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S3055E BP – Bordetella Pertussis DNA Diagnostic Kit

Brief

Pertussis, also known as whooping cough, is a highly contagious respiratory infection caused by the bacterium Bordetella pertussis. Pertussis spreads easily from person to person mainly through droplets produced by coughing or sneezing. The disease is most dangerous in infants, and is a significant cause of disease and death in this age group.

Sansure kit is used to detect Bordetella pertussis DNA present in the nasopharyngeal swab specimens by applying PCR fluorescence probing technique. The detection result can be used as an aid in the diagnosis of bordetella pertussis.

Parameters

Product features	Parameter
Specimen Types	Nasopharyngeal swab
Technical Platform	Fast release technology Advanced magnetic beads technology
Anti-contamination system	UNG enzyme + dUTP system
Internal Control	Internal control plasmid
PCR Instruments	Mx3000P; ABI 7500; MA-6000; S-Q31A/S-Q31B; S-Q36A
Sensitivity	200 copies/mL
Obtained Certificates	NMPA, CE-IVDD etc.

Natch 16S Nucleic Acid Extraction System

Extraction Instruments

Specifications

Model	Natch 16S
Sample throughput	1-16
Extraction technology	Magnetic bead technology
Purification differences between wells	CV≤5%
Mixing mode	Tip comb moving up and down to mix, 10 different mixing modes
Extraction time	10-60 minutes/batch
Anti-contamination	Built-in UV lamp and air filtration system
Operation mode	Touch control
Program management	Create, copy, delete, import, export and edit
Display	7-inch touch screen
Interface	USB
Power supply	Input: AC 100V-240V, 50-60Hz, 120VA
Size	≤200mm×300mm×300mm (L×D×H)
Net weight	≤8Kg

Extraction kit components

No.	Spec.	Product Name
S10016E	48T/kit	Nucleic Acid Extraction-Purification Kit (Magnetic beads method)

Available projects

Sexually Transmitted Diseases : CT, NG, UU, HSV-2, HSV I/2 Women's Health : hrHPV and hrHPV genotyping Respiratory Tract Disease : 6RP, TB, MP, RSV, ADV, BP Gastrointestinal Diseases : HFMD Prenatal and Postnatal care : CMV, EBV Public Health : SARS-CoV-2, Influenza A/B, HINI, H7N9 Customerized Projects

S3174E HCoV-MERS – Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit

Respiratory Tract Infections

Brief

The Human Coronavirus (MERS) is generally detectable in respiratory samples during the acute phase of infection. The Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) can qualitatively detect HCoV-MERS in sputum, alveolar lavage fluid, and throat swabs, the test results can be used to assist in the diagnosis of patients infected with HCoV-MERS, providing a molecular diagnostic basis for coronavirus MERS infection. The test results of this kit are for clinical reference only, and should not be used as the sole criterion for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.

Parameters

Product features	Parameter
Covering Genes	MERS-CoV Orf1b
Specimen Types	Sputum, alveolar lavage fluid, throat swab
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Internal Control Gene	RNase P
Compatible Instruments	ABI 7500, Stratagene Mx3000P, SLAN®-96P, MA-6000, iPonatic S-Q36A/S-Q31A/S-Q31B
Sensitivity	500 copies/mL
Qualification	CE

S3104E 2019-nCoV (FDA EUA)Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

2019-nCoV (FDA EUA)

For in vitro diagnostic use only.

For emergency use only.

For Prescription Use only.

Rx only.

Brief

The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARSCoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal aspirates from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Performance

One-tube/fast release technology
Simple operation process, less specialist training
Room temperature lysis, less contamination
Sampling types: nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal spirates
Internal control: human housekeeping gene RNase P

Parameters

Product features	Parameters
Specimen Type	Nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal spirates
Extraction Platform	Sample Release Reagent Qiagen QIAamp Viral RNA Mini Kit
Target Genes	SARS-CoV-2 ORF1ab, N gene
Internal Control	Rnase P gene
PCR Instrument	ABI 7500 Real-Time PCR System
LoD	200 copies/mL
Spec.	24T, 48T
Qualification	FDA EUA

Notes

This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.

S3353E FluA/Flu B – Influenza A/B Virus Nucleic Acid Diagnostic Kit

Respiratory Tract Infections

Brief

Influenza Virus is a kind of RNA virus in the Orthomyxoviridae family which leading to human and animal influenza. It causes acute upper respiratory tract infection, spreads rapidly through the air and has periodic pandemics around the world. Human influenza virus are influenza pathogens which can be classified into three types, namely A, B and C. Among them, influenza A is the most harmful, while influenza B and influenza C have weak pathogenicity and are not easy to mutate.

The diagnostic Kit is intended for detection of the Influenza A and Influenza B in oropharyngeal swab from individuals. The test results can be used for the auxiliary diagnosis of respiratory Influenza A/B Virus infection and provide molecular diagnostic basis for Influenza A/B Virus infection.

Parameters

Product features	Parameter
Covering pathogens	Influenza A and Influenza B
Specimen Types	Oropharyngeal swab
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Compatible Instrument	ABI 7500; MA-6000; SLAN®-96P; QuantGene 9600; iPonatic S-Q31A/S-Q31B
Sensitivity	200 copies/mL
Spec.	48T, 24-P
Qualification	CE

S3363E-12-P TB and RFP – Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Fluorescence Diagnostic Kit

Respiratory Tract Infections

Brief

Mycobacterium tuberculosis (M. tuberculosis) is the pathogen causing tuberculosis, which can invade all organs of the whole body, and pulmonary tuberculosis caused by pulmonary involvement is the most common. Early diagnosis and treatment are crucial measures to effectively control the spread of tuberculosis.

Due to the abuse of antibiotics or the insufficient course of drugs of patients, the sensitivity of patients to drugs weakens or even disappears, resulting in the decreasing or ineffective effect of drugs on pulmonary tuberculosis. According to the types of anti-tuberculosis drugs, drug-resistant tuberculosis can be divided into monoresistance pulmonary tuberculosis, polyresistance pulmonary tuberculosis, multidrug resistance pulmonary tuberculosis and extensively drug-resistant pulmonary tuberculosis. Rifampicin is one of the first-line drugs for the treatment of pulmonary tuberculosis.

The Mycobacterium Tuberculosis and Rifampicin Resistance Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time polymerase chain reaction test kit intended for the qualitative detection of the nucleic acid of mycobacterium tuberculosis and rifampicin resistance mutations in human sputum samples. The test results can be used to assist in the diagnosis of TB patients and patients with an increased risk of RFP drug-resistant TB, providing a molecular diagnosis basis for infected patients.

Parameters

Product features	Parameter
Specimen Type	Sputum
Technical Platform	One-tube fast release technology
PCR Instruments	iPonatic Ⅲ (S-Q36A)
Internal Control	RNase P
Limit of detection	Mycobacterium tuberculosis 1,000 Bacteria/mL; Rifampicin resistance 10,000 Bacteria/mL

The kit is registered in Indonesia.

Sample Storage Reagent for SARS-CoV-2

Sample Storage Reagent

Brief

The Sample Storage Reagent is intended for preservation and transportation of cells from human body.

The Sample Storage Reagent can protect the stability of virus and intracellular nucleic acid in clinical samples in a short term and is beneficial to the transport of clinical samples.

Kit Components

Item No.	Main Ingredients
X1002E	0.9% normal saline, Rnasin and etc.
X1003E	Sodium chloride, Rnasin and Guanidine Thiocyanate etc.
X1004E	Triton^TM X-100, Tween-20 and ProClin^TM 300 etc.

Order Information

No.	Product Name	Capacity	Spec.
X1002E	Sample Storage Reagent	1mL	48T,96T/Kit
		2mL	24T/Kit
		3mL	24T,48T/Kit
		6mL	24T,48T/Kit
X1003E	Sample Release Reagent	1mL	48T,96T/Kit
		2mL	24T/Kit
		3mL	24T,48T/Kit
		6mL	24T,48T/Kit
X1004E	Sample Storage Reagent	1mL	48T,96T/Kit
		2mL	24T/Kit
		3mL	24T,48T/Kit
		6mL	24T,48T/Kit

S3108E HPV G23 – Human Papillomavirus DNA (23 genotypes) Diagnostic Kit

HPV Infections

Brief

Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of high-risk HPV (Type 6, 11, 16, 18, 26, 31, 33, 35, 39, 42, 43, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 81, 82) present in exfoliated cells from females’ cervix. The test results can be used for identification of HPV genotypes.

Parameters

Product features	Parameter
Specimen Type	Exfoliated cells from females’ cervix
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Detection types	Type 6, 11, 16, 18, 26, 31, 33, 35, 39, 42, 43, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 81, 82
Internal Control	β--globin gene
PCR Instrument	Stratagene ABI7500, Life Technologies QuantStudio^TM5 and SLAN-96P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	24T/48T
Qualification	CE

Order Information

Ref. No.	Product Name	Spec.
S3108E	Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing)	24T, 48T/Kit
S1013E	Sample Release Reagent	48T/Kit
S10016E	Nucleic Acid Extraction-Purification Kit	24T, 48T, 96T/Kit

iPonatic III – Portable Molecular Workstation

mPOCT

Brief

iPonatic III - Portable Molecular Workstation is a new member of Sansure's iPonatic series, optimizing molecular diagnostics with its advanced capabilities. With its cutting-edge technology, iPonatic III ushers in a new "digital and intelligent" era of molecular diagnostics, empowering healthcare professionals and providing rapid and accurate results.

Features

Fully automated rapid testing process and “sample-in-result-out” system make test results available in 15 - 45 minutes.
Pre-packaged kits significantly shorten the hands-on time and reduce the chance of contamination.
Rich and extendable testing menu meets the testing demands of different pathogens from every scenario.
Through innovative wireless connection modules, large smart screen, and flexible combination abilities, samples can be tested anytime upon arrival.
Only 7.2 kilograms (15.84 Pounds)
Benefiting from state-of-the-art “SanUI” interactive system and HD smart touch screen, the test results will be displayed directly.
Top international industrial design standard embodies Sansure’s distinctive design concepts.

Parameters

Model	S-Q36A
Dimension	391 mm×140 mm×368 mm (L×W×H)
Weight	About 7.2kg
Channels	FAM, VIC/HEX, ROX/Texas Red, CY5
Duration	15 - 45min (SARS-CoV-2)
LOD	200 copies/mL (SARS-CoV-2)
Maximum heating rate	≥10℃/sec
Maximum cooling rate	≥3℃/sec
Temperature accuracy	±0.5°C
Functions	Nucleic acid extraction, amplification detection, data analysis
Display	Built-in 7-inch high-definition touch screen, 12.1-inch smart screen (optional)
Interfaces/communication	USB2.0, RJ45, Type-C, WI-FI, Bluetooth, LIS_LH7
Input voltag	100-240 VAC
Power frequency	50/60Hz
Rated power	160VA
Temperature	Operating conditions:10°C- 30°C Transportation and storage: -40°C- 55°C
Humidity	Operating conditions: 30% - 80%, non-condensing Transportation and storage: ≤ 93%, non-condensing
Barometric pressure	85.0kPa - 106.0k Pa
Altitude	Less than 3,000 m
Qualification	CE

Test menu

RTI: SARS-CoV-2 (ORF1ab, N gene) SARS-CoV-2 (ORF1ab, N gene, E gene) SARS-CoV-2/Flu A/Flu B SARS-CoV-2/Flu/RSV Six Respiratory Pathogens (Flu A/Flu B/RSV/AdV/HRV/MP) Acinetobacter baumannii and Canidia albican (AB/CA) Flu A/Flu B Mycoplasma Pneumoniae (MP) Mycobacterium Tuberculosis (TB) Bordetella Pertussis (BP) Respiratory Syncytial Virus (RSV) Streptococcus Pneumoniae (SP) Carbapenemase Gene (KPC) MERS Legionella pneumophila (Lp) Adenovirus (AdV) STI & HPV: HPV 13+2 (Identifies HPV 16 and HPV 18, reports 13 other high risk types in pooled results) HPV 15 HR (Reports 15 high risk HPV types in pooled results) HPV 16&18 HPV 6&11 HSV-2 HSV-1&2 Mycoplasma Genitalium/Mycoplasma Hominis/Trichomonas Vaginalis (MG/MH/TV) Neisseria Gonorrhoeae (NG) Ureaplasma Urealyticum (UU) Mycoplasma Genitalium (MG) Other infections: Epstein-Barr Virus (EBV) Group B Streptococcus (GBS) Toxigenic Clostridium difficile (CD) * Monkeypox Virus (MPXV) *

Use scenarios

Medical laboratories, emergency rooms, fever clinics, remote areas, CDCs, airports, customs, etc.

*All use scenarios must comply with local regulations.

S3046E HIV-1 – Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit

Blood-borne Infections (BBIs)

Brief

The human immunodeficiency virus (HIV) is the causative agent for the worldwide AIDS epidemic, and it has taken nearly 33 million lives worldwide. Sansure's HIV-1 RNA Quantitative Fluorescence Diagnostic Kit is intended for quantitative detection of the HIV-1 Virus RNA in human EDTA plasma specimens. Sansure's HIV-1 RNA kit received CE certificate, supporting the company to provide more quality products and services for international customers, and to help prevent and control AIDS worldwide.

Performance

Patented Modified-Capture Probe Assay Using exclusive modified super-paramagnetic nano-beads to absorb DNA/RNA in the sample； Heating free: Innovative lysis solution, no heating, less aerosol contamination; Single wash step: Unique combination of inorganic and organic solutions for reduced handling steps and reduced HBV DNA loss. Dual Target LTR and GAG gene regions are selected as targets for HIV detection to avoid missed detection, which can improve detection efficiency. High Sensitivity 25 IU/mL, meeting HIV-1 infection clinic guidelines. Internal Control The HIV-1 RNA Kits uses Internal Control is the full name to whole-process the HIV-1 extraction and amplification process to avoid false negative results.

Parameters

Product features	Parameter
Specimen Type	Plasma
Extraction Platform	Advanced magnetic beads technology
Genotype	HIV-1 Group M,N,O
Internal Control	Pseudoviruses
PCR Instrument	SLAN-96P, ABI7500, Roche cobas 480
Sensitivity	25 IU/mL
Linear range	50—1.0E+08 IU/mL
Spec.	48T
Qualification	CE

S3016E MP – Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit

Respiratory Tract Infections

Brief

Mycoplasma pneumoniae (MP) is a pathogenic microorganism between bacteria and virus. It is mainly transmitted through buccal and nasal mucus by the air causing respiratory diseases, with the highest incidence in children and adolescents. Respiratory infection has the manifestations of pharyngitis and bronchitis, with a few cases causing infection to the lung. Recently, incidence among infants and children is increasing, therefore, early diagnosis and treatment can decrease the exacerbation of acute pneumonia in children. The development of molecular biology also draws more attention to the fluorescence quantitative PCR technology for the detection of MP-DNA. This diagnostic kit is an in vitro nucleic acid amplification test for the detection of mycoplasma pneumoniae DNA in humansputum and throat swab. It is intended for use as an aid in the diagnosis of an MP infection and providing a molecular-diagnostics-based solution.

Parameters

Product features	Parameter
Specimen Type	Sputum and throat swab
Extraction Platform	One-tube fast release technology
Internal Control	cloning plasmid containing the target gene fragment
PCR Instrument	ABI 7500, SLAN-96P,MA-6000, Roche LightCycler 480, iPonatic S-Q31A&B,S-Q36A
Sensitivity	400 copies/mL
Spec.	48T, 12-P
Qualification	CE

S3066E 6RP – Six Respiratory Pathogens Nucleic Acid Diagnostic Kit

Respiratory Tract Infections

Brief

Respiratory infections are classified into the upper respiratory tract infections and lower respiratory tract infections. It refer to the pathogens that infect the nose, throat, trachea, bronchi or lungs, which principally cause diseases of tissues and organs outside the respiratory tract, manifested by fever, sore throat, cough, headache and other symptoms. The respiratory tract pathogen has the characteristics of strong infectivity, rapid spread, short incubation period and acute onset, etc. which seriously harm human health. After respiratory infection, symptoms are mostly similar. Sansure six respiratory pathogens joint detection kits can help doctors make differential diagnosis, accurately detect the pathogens that cause symptoms, and formulate treatment plans.

Performance

High sensitivity: Super-cis-nanometer magnetic bead technology; can achieve 500copies/mL
Accurate identification: One test presented six results ; accurate guidance for rational clinical drug use
Whole-process monitoring: Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) human housekeeping gene as internal standard; Monitor the whole process of sampling, nucleic acid extraction and amplification

Parameters

Product features	Parameter
Specimen Type	Nasopharyngeal swabs
Extraction Platform	Advanced magnetic beads technology
Internal Control	lentivirus particles（GAPDH）
PCR Instrument	SLAN-96P, ABI7500
Sensitivity	Influenza A virus: 2.0 TCID₅₀/mL Influenza B virus: 2.0 TCID₅₀/mL Respiratory syncytial virus: 500.0 copies/mL Adenovirus: 500.0 copies/mL Mycoplasma pneumonia: 500.0 copies/mL Human rhinovirus: 500.0 copies/mL
Spec.	24T
Qualification	CE

S3334E ADV – Adenovirus Nucleic Acid Diagnostic Kit

Respiratory Tract Infections

Brief

Acute infectious disease caused by adenovirus, easily affects the mucous membranes of the respiratory and digestive tracts, the conjunctiva of the eyes, the urinary tract and the lymph nodes. The main manifestation is an acute upper respiratory tract infection. The population is generally susceptible, mostly the children. Infants are susceptible to adenovirus pneumonia, which is severe and has a high mortality rate. The source of infection is the patient and the latent infected person. The virus is excreted from the respiratory tract and conjunctival secretions, feces and urine, and is transmitted by airborne droplets, close contact and the feces-oral route. The Adenovirus Nucleic Acid Diagnostic Kit is used for nucleic acid testing of adenovirus in patients suspected of being adenovirus infections (e.g., fever, cough, wheezing, dyspnea, bronchopneumonia, upper respiratory tract infections, lung infections, etc.) or related close contacts, and the results can be used to assist in the diagnosis of adenovirus infection and provide a molecular diagnostic basis for adenovirus infection.

Features

High sensitivity: Detection sensitivity reaches 200 copies/mL.
Quick and easy: Perfectly match Sansure's one-tube fast Sample Release Reagent, easy to operate.
IC monitoring: IC(Internal Control) monitoring test process to avoid false negative results.

Parameters

Items	Parameter
Specimen Type	Throat swab
Extraction Platform	One-tube fast release technology Advanced magnetic beads technology
Anti-contamination system	UNG enzyme + dUTP system
PCR Instrument	ABI 7500; MA-6000; SLAN-96P; QuantStudio 5; iPonatic S-Q31A&B; S-Q36A
Sensitivity	200 copies/mL
Qualification	NMPA, CE

S3018E TB – Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit

Respiratory Tract Infections

Brief

Mycobacterium tuberculosis virus (TB) is a pathogenic bacterium that causes tuberculosis. It is likely to infect all human tissues and organs, especially the lungs to cause pulmonary tuberculosis. Early diagnosis and treatment are important for effective control of tuberculosis. In recent years, with the development of molecular biology, nucleic acid fluorescence quantitative PCR method based on the mycobacterium tuberculosis nucleic acid has drawn more and more attention from researchers.

Parameters

Product features	Parameter
Specimen Type	Human sputum
Extraction Platform	One-tube fast release technology
Internal Control	Cloning plasmid, without TB target sequence
PCR Instrument	ABI 7500, SLAN-96P,MA-6000, Stratagene Mx3000P, iPonatic S-Q31A&B,S-Q36A
Sensitivity	1 bacterium/mL
Spec.	48T, 12-P
Qualification	CE

S3310E 6LRP – Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit

Respiratory Tract Infections

Brief

Lower respiratory infections (LRP) remained the world’s most deadly communicable disease, ranked as the 4th leading cause of death. In 2019 it claimed 2.6 million lives. Diseases of the lower respiratory tract include acute tracheitis, bronchitis, pneumonia, chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, etc. They are caused by microbial infections such as viruses, bacteria, mycoplasma, chlamydia and legionella. Bacteria are the main pathogens of lower respiratory tract infections, with a wide variety of pathogens and complex clinical presentations. Due to the long detection period and low positive detection rate of traditional pathogenic tests, over 62% of adults with community-acquired pneumonia have no pathogenic basis. Failure to identify the cause quickly can delay treatment, exacerbate the disease and lead to death, and increase the development of antibiotic resistance.

Features

Highly efficient identification and rapid diagnosis: Six common bacteria of lower respiratory tract infections can be detected in one tube; a batch of 94 sample tests can finish in 100 minutes.
Accurate and reliable, high detection rate: sensitive and specific, unaffected by antibacterial drugs, full internal control monitoring to avoid false negatives, UDG enzyme + dUTP anti- contamination measures to reduce false positives.
Easy to operate and adaptable: automatic instruments are available, and the results can be intelligently analyzed by conventional fluorescent PCR instruments to meet the needs of medical laboratories , clinical Institutions, emergency and primary care etc.

Parameters

Items	Parameter
Specimen Type	Sputum
Extraction Platform	Advanced magnetic beads technology
Internal Control	Plasmid
PCR Instrument	Thermofisher QuantStudio™ 5 and SLAN-96P
Sensitivity	15 CFU/mL (Streptococcus pneumoniae) 340 CFU/mL (Legionella pneumophila) 625 CFU/mL (Haemophilus influenzae) 675 CFU/mL (Pseudomonas aeruginosa) 900 CFU/mL (Klebsiella pneumoniae) 2875 CFU/mL (Staphylococcus aureus)
Qualification	NMPA, CE

S3352E MPXV – Monkeypox virus Nucleic Acid Diagnostic Kit

Other Infections

Brief

Monkeypox is a disease of global public health importance as it not only affects countries in west and central Africa, but the rest of the world. Human-to-human transmission can result from close contact with respiratory secretions, skin lesions of an infected person or recently contaminated objects. Transmission via droplet respiratory particles usually requires prolonged face-to-face contact, which puts health workers, household members and other close contacts of active cases at greater risk. WHO recommends polymerase chain reaction (PCR) is the preferred laboratory test given its accuracy and sensitivity.

Performance

Test time ≤ 30 min
Sensitivity: 200 copies/mL
Suitable for PCR and iPonatic

Parameters

Items	Parameters
Specimen Type	Vesicles or pustules, nasopharyngeal swab, oropharyngeal swab, serum, whole blood
Extraction Platform	One-tube fast release technology Advanced magnetic beads technology
Internal Control	Human gene
PCR Instrument	ABI 7500, QuantStudio™ 5, LightCycler 480, MA-6000, SLAN-96P, QuantGene 9600, Portable Molecule Workstation S-Q31A&B, Portable Molecular Workstation S-Q36A
Sensitivity	200 copies/mL
Spec.	48 T, 12-P
Qualification	CE

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C004E BCI – Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2)
Blood-borne Infections (BBIs)
Brief
Nucleic Acid Test Kit for HBV,HCV,HIV(Type1+2), is based on real-time fluorescence PCR technology and used for nucleic acid qualitative detection of HBV, HCV, HIV1+2 in plasma. This kit is intended for use as a blood donor screening test to detect HBV DNA, HCV RNA, HIV-1 RNA and HIV-2 RNA in pooled or individual sample from healthy blood donors, blood donors of various components (red blood cells, platelets and plasma) and other types of blood donors. All plasma to be tested can be screened as individual samples or tested in pools after mixing with each equal aliquots according to routine serological screening results HBV, HCV and HIV samples. For the pooled sample showed positive test results, carry out individual testing, the individual test result should be used as the final test result of this sample. The test results of this diagnostic kit can distinguish reactivity of between HBV, HCV and HIV.
Advantages
High sensitivity
- HBV 2.41 IU/mL
- HCV 12.38 IU/mL
- HIV-1 31.68 IU/mL
- HIV-2 48.34 IU/mL
High efficiency
- 576 tests/ 5h（pooling）
- 96 tests / 4.5h（single)
Complete subtypes coverage
- HBV genotypes A-H
- HCV genotypes 1-6
- HIV-1 group M/N/O
- HIV-2
Single pipe joint inspection
- Four tests for a tube of samples
- Direct discriminating positive
Automated detection
- Extraction and amplification process
- No need to be on duty
Cost and space savings
- One extractor + one amplifier
- Less consumable material consumption
Features
Sample preparation and extraction in one module Fully automatic sample preparation and nucleic acid extraction in one module to build up a integrated reaction system Flexible testing mode 6 pooling sample testing or individual donor testing (IDT) supported Advanced magnetic beads technology Nanometer-level beads enable beads-in-PCR amplification ensuring maximum nucleic acid template Patented magnetic beads lateral suction technology Thorough waste liquid removal allows minimal magnetic beads loss Sophisticated sample information processing Automatic recognition of the sample barcode & sample tracking and archiving table generation available High throughput 558/96 samples result output in one time Minimal system maintenance time Less than 20 minutes startup with fewer maintenance tasks Excellent accuracy A total number of 105,124 blood bags which confirmed as negative by serological testing were tested against some referential screening kits. 15 false-negative results in reference tests were found.
Parameters

Qualification CE
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S3120E-H-SARS-CoV-2 Rapid Antigen Test for Self-testing
Respiratory Tract Infections
Brief
The SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) for self-testing is authorized for home use with self-collected nasal swab samples to directly detect antigen of SARS-CoV-2 virus. With the help of this kit, people without professional training can also easily acquire their COVID-19 test result within 15-20 minutes.
Features
- Accurate Sensitivity 94.55%, Specificity 100%
- Convenient No instrument needed, easy to operate
- Fast Result available in only 15-20 min
- Flexible Get tested anytime when you are free
Instruction

Result interpretation

Parameters

Qualification CE

Kit components

No. Product Name Spec.

S3120E-1-H, S3120E-5-H SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) 1 Test, 5 Tests

The kit components:
- SARS-CoV-2-Antigen Test Cassette (with desiccant)
- SARS-CoV-2 Sample Extraction Buffer
- Swab
- Plastic Waste Bag
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S3109E SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method)
Respiratory Tract Infections

Brief
The SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) is intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein in human nasopharyngeal or nasal swab sampled from individuals suspected of COVID-19.
Parameters

Testing Time 10-15 minutes

Sensitivity 98.4%

Specificity 98.1%

Qualification CE

Kit components

No. Product Name Spec.

S3109E-25 SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) 25 tests

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iPonatic – Portable Molecule Workstation

mPOCT, PCR Instruments

Brief

Innovations in molecular assays—especially on the point-of-care testing (POCT) front—have spread this testing from molecular diagnostics laboratories into clinical microbiology laboratories—and now into general laboratories and even clinics and exam rooms.^[1] Access to sensitive and rapid infectious disease diagnostic assays is essential for accurate diagnosis, effective treatment, and timely infection control, making POCT vital to reducing TAT. With novel POCT on the horizon, future studies are warranted to determine cost savings, antimicrobial usage, TAT, patient impact, and how to best implement in non-microbiology clinical laboratories and clinics.^[2] Sansure iPonatic (Portable Molecule Workstation) aims to innovate traditional diagnostic mode and assist precision diagnosis. It can provide quickly and convenient diagnosis experience for clinical emergency, health management, military safety, biological emergency and other applications.

Core technologies

Rapid nucleic acid lysis at room temperature within 1 minute
Ultra fast amplification system in 8-45 minutes
Integrated automatic data analysis software
Results immediately printed by built-in printer

Performance

Diagnostic results consistent with international mainstream PCR instruments

Parameters

Model	S-Q31A		S-Q31B
Detection platform	Real-time PCR
Detection module	1 amplification module		4 amplification modules
Temperature control	Liquid metal coated ceramic heating / Air cooling technology
Heating rate	≥6.0℃ /s (from 50℃ to 95℃ )
Cooling rate	≥2.0℃ /s (from 95℃ to 50℃ )
Excitation light source	LED
Detector	High sensitivity photodiode
Applicable dyes	FAM	VIC	ROX	CY5
Sensitivity	Can detect single copy gene
Electrical specification	AC 100-200V 50/60Hz
Dimension	230×284×376 mm (L×W×H)		336.5 × 280 × 435 mm (L×W×H)
Weight	9.7Kg		13Kg
Qualification	CE

Test menu

Respiratory Infections : SARS-CoV-2, SARS-CoV-2/FluA/B, MP, ADV, BP.... HPV Infections : HrHPV, HPV 13+2, HPV 16/18, HPV 6/11.... Children's health : EBV, HCMV.... STIs : CT/UU/NG, CT, UU, NG, HSV-2.... Other test projects are under development

References

[1]. Kozel TR, Burnham-Marusich AR. Point-of-care testing for infectious diseases: Past, present, and future. J Clin Microbiol 2017;55:2313-20.

[2]. Paige M.K. Larkin, Omai B. Garner. Molecular Point-of-Care Testing in Clinical Laboratories Laboratorians can lead a new era in rapid testing with expertise in quality control and result interpretation. Clinical Laboratory News. JUL.1.2020

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MA-6000 Real-Time Quantitative Thermal Cycler

PCR Instruments

Brief

The MA-6000 Real-Time Quantitative Thermal Cycler has spent many years in the research and development phase, but it was worth the wait as this advanced technology will help you treat more patients and cut down your waiting times with its ability to process up to 96 samples at one time. Our new Real-Time fluorescence quantitative PCR system MA-6000 is equipped with innovative hardware, structure and optimised software to deliver higher quality results.

Features

Temperature Control Technology and Innovation MA-6000 employs a six independent temperature control module, associated with an infrared environmental scanning and monitoring system for temperature control and secured precision for the thermal block. A technologically designed thermal gradient customises twelve thermal conditions for multiple reaction actions in scientific research, maximising convenience for your research and scientific experiments. The MA-6000’s platinum sensor prevents temperature overshoot and undershoot, homogenised temperature variance which in tandem offer customers reliably excellent and repeatable data output. The World's Leading Optical Detection Technology’s Built-In Advantages A world leading technology of optical conduction and detection is applied to MA-6000. A highly functional heat-resistance optical fibre conducts full-spectrum halogen light source to samples without attenuation. The emission fluorescence signals are synchronously collected by monochrome CCD, which together with its cooling system, physically eliminate dark current on the detection array. MA-6000 ensures extraordinary detection sensitivity, extends the application of thermal cycler from nucleic acid to biotinylated protein and expands a brand-new path for multiplex diagnosis in clinical field.

Specifications

PCR Module
Sample capacity	96×200ul tubes / 12 x 8-well PCR strips / l x 96-well plate
Temperature range	4-100 ℃
Maximum ramp rate	3.5 ℃/s for heating; 3.2℃/s for cooling
Temperature accuracy	± 0. 1 ℃
Temperature uniformity	±0.25℃
Temperature monitoring method	6 independent zones for temperature surveillance
Gradient capability	Yes
Excitation light source	Full spectrum halogen lamp(5 years warranty)
Excitation spectrum	380-780nm
Excitation channels	Built-in 6(including I extension channels)
Fluorescence dyes/probes	FAM / SYBR Green I / VIC / HEX / TET / Cy3 / Cy3.5 / JOE / Yellow 555 / ROX / Texas Red / Cy5 / Cy5.5 / LC Red / Tamara
Detection channels	96 two-way heat-resistance optical fibers
Data resolution	5.000-10.000 copies with 99.8% confidence; 1.5 times differentiation for single reaction
Thermo Cycler
Power supply	100-240V
Frequency	50-60Hz
Dimensions(WxHxD)(cm)	54.8×38.8×28.8
Weight	23kg
Software	Win7, Win8, Win10, etc.
Qualification	CE

SLAN-96P Real-Time PCR System

PCR Instruments

Features

Precise Temperature Control System: 1. The SLAN system adopts Peltier technology which can accurately and quickly control increases and decreases of temperature with a precision of ±0.1℃ and features long service life, no noise and no pollution, etc.; 2. Multiple-point temperature control technology ensures the uniformity between different wells. The temperature correction technology guarantees the accuracy of temperature and thus ensures the accuracy of assay result; 3. PCR tube temperature-control technology guarantees the accuracy of actual temperature of reagent in the tube and enables the SLAN to easily adjust for different reactions using different volumes. Sensitive Photoelectric Detection System 1. High sensitivity photoelectric detector with no background noise which is fast and stable; 2. Lifetime maintenance-free ultra-bright LED cold light source with a large signal value and high stability; 3. Unique optical fiber conduction technology that greatly improves fluorescence collection efficiency and avoids fluorescence interference between neighboring tubes; 4. The system automatically selects best gain value for each tube without the need for user configuration. The SLAN^®has an extremely broad measuring range for fluorescence; 5. Extremely high detection sensitivity with an extremely low fluorescence background value. It's not necessary for users to make optical correction or background correction.

SLAN-96P Multi-tasking Software Interface (analysis screen)

Unique Electronic Automatic Hot Lid System 1. Flexible heating technology ensures uniform hot lid temperature; 2. The electronic automatic hot lid has an adjustment function for different 0.2ml reaction tubes to ensure even tube pressure; 3. Once the assay starts, the hot lid has automatic locking function to prevent assay failure following accidental opening. Other functions

· Power-off protection	· Automatic saving result	· Export of result
· Real-time data display	· Quantitative and qualitative analysis	· File encryption
· Automatic baseline optimization	· Digital filtering	· Search function
· Report sheet print and edit	· Melt curve function

Specifications

Product model	SLAN-96P
Sample capacity	96 wells (dual 48/48 reaction module)
Sample size	15-50mL
Consumable	0.2mL PCR tubes, 8-tube strips, 48-well plates
Parallel running mode	Dual reaction blocks/running 2 tests independently
Temperature range	4-99°C
Max ramp rate	4.0°C/sec
Temperature accuracy	±0.1°C
Temperature uniformity	±0.1°C
Thermal cycling system	Peltier-based system
Temperature control mode	Tube control/block control
Light Source	LED (maintenance-free)
Detector	High sensitivity photoelectric sensor
Sensitivity	1 copy
Linearity range	10⁰-10¹⁰
Resolution	Can discriminate between 1000 copies and 2000 copies
Excitation	CH1 470nm CH2 530nm CH3 580nm CH4 630nm CH5/CH6 custom-made
Emission	CH1 510nm CH2 565nm CH3 620nm CH4 665nm CH5/CH6 custom-made
Dyes and probes	CH1 FAMTM /SYBRGreen® CH2 VIC®/HEX/J0ETM /TET CH3 ROX/TexasRed® CH4 CY5TM
Hot-lid	30°C~108°C (default105°C, adjustable) electronic automatic hot-lid
Power supply	230VAC, 50Hz
Power consumption	850VA
Dimensions	380mm x 520mm x 250mm (WxDxH)
Weight	18Kg
Communication	RS232, USB
Qualification	CE

Natch 48 Nucleic Acid Extraction System

Extraction Instruments

Extremely simple workflow

Specifications

Instrument model	Natch 24/48/96
Sample type	Serum, plasma, whole blood, secretions, exfoliated cells, tisues, throat swabs, anal swabs, urine, feces, etc.
Extraction technology	Advanced magnetic beads technology
Sample type Volume	1-96 tests/batch
Extraction Time	10-60 minutes each batch
Working volume	30-2000uL
Recovery rate of magnetic beads	＞95%
Blending mode	Vortex omnidirectional liquid mixing
Temperature control range	Adjustable from roomtemperature to 125℃
Operation	7-inch touch screen
Storage	Up to 120 groups of programs can be used.
Size and weight	655x655x520 mm (L x W x H), weight: 65kg
Qualification	CE

Extraction kit components

No.	Spec.	Product Name
S10016E	48T/kit	Nucleic Acid Extraction-Purification Kit (Magnetic beads method)

Available projects

Natch CS2 Fully Automated Nucleic Acid Extraction System

Extraction Instruments

Extremely simple workflow

Features

1. Efficient anti-contamination

Well-organized countertop layout
Sample area is separated from clean area
Effective UV decontamination
Anti-contanmination function of moving path

2. Super magnetic, effective adsorption

Super 3-D magnetic adhesion technology
Permanent magnetic mode
117 magnetic racks, 4 magnetic bars in each well

3. Excellent sample addition function

Automatic liquid level detection
Clot detection
Tip detection
Air-prof detection

4. Easy-to-use software

Preset programs, one-key selection
Prompt the placement of reagents
Display the status of reagents and consumables
Real-time display of remaining time
Show real-time experimental procedures
Permits LIS compatibility

Specifications

Instrument model	S-S13A
Sample type	Serum, plasma, whole blood, secretions, exfoliated cells, tissues, nasopharyngeal swab, oropharyngeal swab, urine, feces, etc.
Sample tube specifications	Compatible with various original sample tubes
Extraction Principle	one-tube fast release technology (OT) Advanced magnetic beads technology (MB)
Sample type Volume	OT: 1-96 tests/batch; MB: 1-96 tests/batch
Extraction Time	OT of 96 tests ≤ 30 minutes; MB of 96 tests ≤ 90 minutes
Pipetting range	10~1000 μL
Level detection	Pressure detection / capacitance detection, automatic detection of liquid level
Clot detection	Pressure detection, automatic detection of liquid aspiration and liquid clogging
Sample loading function	Automatic liquid level detection Clot detection Tips detection Air-prof detection
Magnetic field control	Permanent magnet mode Patented design Super 3-D magnetic adhesion technology
Blending mode	Vortex omnidirectional liquid mixing
Temperature control range	Adjustable from room temperature to 100℃
UV disinfection	Timed opening and closing
Barcode Scanning	Sample scanning system Supported multiple barcodes
Language	Simplified Chinese / English
Display Method	10.4 inches touch screen
Communication Interface	USB, RS232, network ports, HDMI
Dimensions and Weight	1320×850×1600mm (LxWxH), weight: 350Kg
Power supply	Input: AC 100-240V 50/60Hz 350 VA
Qualification	CE

Extraction kit components

No.	Spec.	Product Name
S1013E	48T/kit	Sample Release Reagent
S1014E	24T/Kit, 48T/kit	Sample Release Reagent
S1002E	24T/kit	Nucleic Acid (DNA/RNA) Extraction or Purification Kit (Magnetic beads method)
S1006E	48T/kit	Multi-type Sample DNA/RNA Extraction-Purification Kit (Magnetic beads method)
S10016E	48T/kit	Nucleic Acid Extraction-Purification Kit (Magnetic beads method)

Available projects

Hepatitis and AIDS : HBV, HCV, HIV Sexually Transmitted Diseases : CT, NG, UU, HSV-2, HSV I/2 Women's Health : hrHPV and hrHPV genotyping Respiratory Tract Disease : 6RP, TB, MP, RSV, ADV, BP Gastrointestinal Diseases : HFMD Prenatal and Postnatal care : CMV, EBV Public Health : SARS-CoV-2, Influenza A/B, HINI, H7N9 Customerized Projects

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S1006E Multi-type Sample DNA/RNA Extraction-Purification Kit
DNA/RNA Extraction Reagents

Brief
Multi-type Sample DNA/RNA Extraction-Purification Kit (Suprall extraction reagent) is an innovative product based on Sansure advanced magnetic beads technology platform , which can accomplish the unified extraction of nucleic acids in various gene detection applications and samples to provide comprehensive solutions for nucleic acid extraction , can be applied in infectious disease diagnosis, genetic disease screening, birth defect prevention, tumor screening, individualized diagnosis and treatment, detection of disease susceptibility genes, sequencing services and other fields.
Parameters

Qualification CE

Kit components

No. Product Name Spec.

S1006E Multi-type Sample DNA/RNA Extraction-Purification Kit 24T/kit

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Nucleic Acid (DNA/RNA) Extraction or Purification Kit

DNA/RNA Extraction Reagents

Brief

Nucleic Acid (DNA/RNA) Extraction or Purification Kit developed based on Sansure advanced magnetic beads technology platform，using exclusive modified super-paramagnetic nano-beads to absorb sample DNA/RNA , only needs a simple step of washing to obtain high purity nucleic acid, combined with the "DNA/RNA elution-free " technology and integrated high-efficient amplification system, to achieve DNA/RNA amplification detection with magnetic beads.

Parameters

Qualification

Kit components

No.	Product Name	Spec.
S1002E	Nucleic Acid (DNA/RNA) Extraction or Purification Kit	24T/kit
S10011E	Nucleic acid (DNA/RNA) extraction or purification kit	24T/Kit, 48T/kit
S10016E	Nucleic Acid Extraction-Purification Kit	48T/kit, 96T/kit

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Sample release reagent
DNA/RNA Extraction Reagents

Brief
Sample release reagent developed based on the Sansure one-tube fast release technology platform. Adopting Sansure patent nucleic acid release technology, can quickly lyse pathogens at room temperature, no need heating, centrifuging or replacing tubes, the sample DNA/RNA can be extracted quickly through simple operations. Sample Release Reagent is used for the pretreatment of nucleic acids, to release the nucleic acids from specimens, then the released nucleic acids can be used for clinical in vitro diagnosis or used for the detection through equipment.
Parameters

Qualification CE

Kit components

No. Product Name Spec.

S1011E Sample Release Reagent 48T/kit

S1013E Sample Release Reagent 48T/kit

S1014E Sample Release Reagent 24T/Kit, 48T/kit

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S3053E EV/EV71/CA16 – Enterovirus/Coxsackievirus A16/Enterovirus 71 RNA Diagnostic Kit

Gastrointestinal Infections (GIIs)

Brief

Hand-foot-and-mouth disease is a common childhood disease caused by enteroviruses. Most of the patients will have a fever and get vesicle rash in the mouth or on the hand and foot. A few patients will get cephalomeningitis, cerebritis, neurogenic pulmonary edema and myocarditis, etc. Some patients may get sequelae of this disease or even death. The viruses that can cause hand-foot-and-mouth disease include Coxsackievirus, new-type enterovirus and ECHO virus, of which the most common types are Coxsackievirus A16 and Enterovirus 71. The laboratory diagnosis methods mainly include virus isolation, nucleic acid detection, etc. The Enterovirus/Coxsackievirus A16/Enterovirus 71 RNA Diagnostic Kit (PCR-Fluorescence Probing) is intended to detect Enterovirus, Coxsackievirus A16 and Enterovirus 71 in throat swab by applying real-time quantitative PCR technique. The detection results can be used to distinguish Coxsackievirus A16 and Enterovirus 71.

Parameters

Product features	Parameter
Specimen Type	throat swab
Technical Platform	Advanced magnetic beads technology
Target pathogen	EV, EV71, CA16
Internal Control	Lentivirus
PCR Instrument	ABI7500,SLAN-96P
Amplification Time	100 min
Sensitivity	1000 copies/mL
Spec.	24T
Qualification	CE

S3014E HCMV – Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit

Other Infections

Brief

Human cytomegalovirus (HCMV), also called cell inclusion body virus, is a double helix DNA virus and belongs to β genus of herpes virus family, which causes infected cells to enlarge and has a huge intranuclear inclusion. The ways of infection of HCMV is mainly through contact, blood transfusion, intrauterine and birth canal, and the infections are commonly found in fetus, newborns, pregnant women, etc. If the pregnant women are infected, it may cause their newborns congenital monstrosity. When the organism immune deficiency or immune system is under inhibitory state, people can be easily infected by HCMV, such as the patients receiving immunosuppressive therapy after transplantation of organ, the patients receiving malignant tumor chemotherapy and AIDS patients, etc. If these patients are infected by HCMV, it usually causes high mortality and serious diseases. Clinical tests suggest that HCMV infection hasn’t specific manifestations and it causes harm to multiple organs, especially the liver and lung. A statistical analysis of positive and negative rate of HCMV in various kinds of clinical indications shows HCMV infection is probably related with various diseases, such as Cytomegalovirus hepatitis, Infant hepatitis syndrome, liver dysfunction, pneumonia, Bronchitis, Upper respiratory tract infections, enteritis, enterocolitis, diarrhea, hematemesis, heart failure, etc. The Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of HCMV DNA in human urine, serum and peripheral blood samples. It is intended for use as an aid in the diagnosis of an HCMV infection and for observing drug efficacy.

Parameters

Product features	Parameter
Specimen Type	urine, serum, and peripheral blood.
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Target pathogen	HCMV
Internal Control	cloning plasmid
PCR Instrument	ABI7500, Roche LC 480 and Stratagene Mx3000P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T
Qualification	CE

S3015E EBV – Epstein-Barr virus DNA Quantitative Fluorescence Diagnostic Kit

Other Infections

Brief

Epstein-barr virus (EBV) is known to be the first virus that is definitely related with human tumors. EBV infection mainly causes infectious mononucleosis in children and tumor-related diseases such as Burkitt’s lymphoma, lymphoid tissue hyperplasia in immunocompromised individuals, primary lymphoma, empyema associated lymphoma, T-cell lymphoma, NK cell lymphoma/leukemia, Hodgkin’s disease, nasopharyngeal carcinoma, stomach cancer, lymphoid epithelial tissue cancer, smooth muscle tumors, etc. The Epstein-Barr virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the quantification of Epstein-Barr Virus (EBV) DNA in peripheral blood. Test result can be used as an aid in the diagnosis of an EBV infection and in observation of drug efficacy.

Parameters

Product features	Parameter
Specimen Type	peripheral blood.
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Target pathogen	EBV
Internal Control	cloning plasmid
PCR Instrument	ABI7500, Roche LC 480 and Stratagene Mx3000P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T
Qualification	CE

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C003E BCI – Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2)
Blood-borne Infections (BBIs)
Brief
Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2), is based on real-time fluorescence PCR technology and used for nucleic acid qualitative detection of HBV, HCV, HIV1+2 in plasma. This kit is intended for use as a blood donor screening test to detect HBV DNA, HCV RNA, HIV-1 RNA and HIV-2 RNA in pooled or individual sample from healthy blood donors, blood donors of various components (red blood cells, platelets and plasma) and other types of blood donors. All plasma to be tested can be screened as individual samples or tested in pools after mixing with each equal aliquots according to routine serological screening results HBV, HCV and HIV samples. For the pooled sample showed positive test results, carry out individual testing, the individual test result should be used as the final test result of this sample. The test results of this diagnostic kit can distinguish reactivity of between HBV, HCV and HIV.
Advantages
High sensitivity
- HBV 3IU/mL
- HCV 10IU/mL
- HIV 45IU/mL
High efficiency
- 576 tests/ 5h（pooling）
- 45 tests / 4.5h（single
Complete subtypes coverage
- HBV A-H
- HCV 1-6
- HIV-1（M/N/O）and HIV-2
Single pipe joint inspection
- Four tests for a tube of samples
- Direct discriminating positive
Automated detection
- Extraction and amplification process
- No need to be on duty
Cost and space savings
- One extractor + one amplifier
- Less consumable material consumption
Features
Sample preparation and extraction in one module Fully automatic sample preparation and nucleic acid extraction in one module to build up a integrated reaction system Flexible testing mode 6 pooling sample testing or individual donor testing (IDT) supported Advanced magnetic beads technology Nanometer-level beads enable beads-in-PCR amplification ensuring maximum nucleic acid template Patented magnetic beads lateral suction technology Thorough waste liquid removal allows minimal magnetic beads loss Sophisticated sample information processing Automatic recognition of the sample barcode & sample tracking and archiving table generation available High throughput 558/45 samples result output in one time Minimal system maintenance time Less than 20 minutes startup with fewer maintenance tasks Excellent accuracy A total number of 105,124 blood bags which confirmed as negative by serological testing were tested against some referential screening kits. 15 false-negative results in reference tests were found.
Parameters

Qualification CE
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S3034E HCV Genotype – Hepatitis C Virus Genotype Diagnostic Kit

Blood-borne Infections (BBIs)

Brief

By applying real-time PCR technology, the Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing) is designed for qualitative identification of HCV genotypes (including genotypes 1b, 1, 2, 3, 4, 5 and 6) from HCV RNA positive samples. The test results can be used as an aid in the identification of HCV genotypes and determination of an appropriate therapeutic treatment indicated for the above listed gentoypes. The results can be used only for clinical reference, and cannot be used as the only evidence for adjusting therapeutic drugs. Clinical symptoms and other laboratory test results should also be considered to comprehensively determine the patients treatment.

Parameters

Product features	Parameter
Specimen Type	serum
Extraction Platform	Magnetic beads technologies
Genotype	1b, 1(1b, 1a), 2 (2a), 3 (3a, 3b), 4 (4a), 5 (5a), 6 (6a)
Internal Control	Plasmid
PCR Instrument	Mx3000P,Slan 96P
Sensitivity	1000 IU/mL
Spec.	12T
Qualification	CE

S3119E HCV Ultra – Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit

Blood-borne Infections (BBIs)

Brief

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the quantification of HCV RNA in human serum or plasma. It is intended for use as an aid in the diagnosis of an HCV infection and observing drug efficacy. Hepatitis C is mainly caused by HCV infection and transmitted through blood. Chronic infection of HCV can lead to chronic inflammation of liver and fibrosis, and some patients may develop into liver cirrhosis, even Hepatocellular Carcinoma (HCC). It has huge harms on patients’ health and life quality, and has become a severe social and public health issue.

Parameters

Product features	Parameter
Specimen Type	Plasma
Extraction Platform	Advanced magnetic beads technology
Genotype	HCV 1-6 genotype
Internal Control	Lentivirus particles
PCR Instrument	SLAN-96P, ABI7500, Roche cobas 480
Sensitivity	12 IU/mL
Linear range	25—1.0E+08 IU/mL
Spec.	24T
Qualification	CE

S3013E HBV fast – Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit

Blood-borne Infections (BBIs)

Brief

Hepatitis B Viral (HBV) DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the quantification of HBV DNA in human serum or plasma. It can be used to evaluate antiviral treatment and monitor the therapeutic effect by monitoring HBV DNA baseline levels and changes in patient blood. Test results should not be taken as the only indicator for evaluation of diseases, but to be combined with patients clinical symptoms and other laboratory tests to analyze the diseases.

Parameters

Product features	Parameter
Specimen Type	Serum or plasma
Extraction Platform	One-tube fast test release
Genotype	HBV genotype A-H
Internal Control	Plasmid
Compatible Instrument	ABI7300 , Stratagene Mx3000P , Roche Light Cycler 480 , ABI7500, SLAN-96P and QuantStudio 5
Sensitivity	30 IU/mL
Linear range	100—5.0E+09 IU/mL
Spec.	24T, 48T

S3118E HBV Ultra – Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit

Blood-borne Infections (BBIs)

Brief

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) (HBV Ultra) is an in vitro nucleic acid amplification test for the quantification of Human HBV DNA in human serum. It is intended for use as an aid in diagnosing an HBV infection and observing drug efficacy.

Performance

Advanced magnetic beads technology HBV DNA detection and viral load measurement are essential for treatment decisions and patient monitoring. Sansure's HBV Ultra uses the advanced magnetic beads technology to extract HBV DNA from clinical Plasma. Our technology achieved high sensitivity and wide linear range detection to meet of clinical diagnosis and follow-up needs. Highly conservative primer probe design Sansure primers and probes target select the highly conservative S gene of HBV, which can cover A-H genotypes and avoid missed detection. High-efficient quality control system HBV Ultra uses UNG enzyme + dUTP system to remove carry-over contamination to avoid a false positive result. HBV Ultra uses Internal Control HBV Ultra uses Internal Control is the full name to whole-process the HBV extraction and amplification process to avoid false negative results.

Parameters

Product features	Parameter
Specimen Type	Plasma
Extraction Platform	Advanced magnetic beads technology
Genotype	HBV genotype A-H
Internal Control	Pseudoviruses
PCR Instrument	SLAN-96P, ABI7500, Roche cobas 480
Sensitivity	5 IU/mL
Linear range	20—2.0E+09 IU/mL
Spec.	48T
Qualification	CE

S3017E HPV 6,11 – Human papillomavirus (Type 6 and 11) DNA Fluorescence Diagnostic Kit

HPV Infections

Brief

HPV (Type 6 and 11) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of low-risk HPV (type 6/11) DNA in reproductive tract secretions. It is intended for use as an aid in the diagnosis of an HPV (type 6/11) infection and patients with clinically suspected genital warts.

Parameters

Product features	Parameter
Specimen Type	reproductive tract secretions
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Detection types	type 6, 11
Internal Control	β--globin gene
PCR Instrument	ABI7500,QuantStudio 5, Stratagene Mx3000P, MA-6000, SLAN-96P, LightCycler® 480 II,iPonatic S-Q31A&B,S-Q36A
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T, 12-P
Qualification	CE

S3019E HPV 16, 18 – Human papillomavirus (Type 16 and 18) DNA Fluorescence Diagnostic Kit

HPV Infections

Brief

HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of high-risk HPV (Type 16 and 18) DNA in reproductive tract secretions. It is intended for use as an aid in the diagnosis of an HPV (Type 16 and 18) infection, and the early screening of cervical cancer.

Parameters

Product features	Parameter
Specimen Type	reproductive tract secretions
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Detection types	type 16, 18
Internal Control	β--globin gene
PCR Instrument	ABI7500,QuantStudio 5, Stratagene Mx3000P, MA-6000, SLAN-96P, LightCycler® 480 II,iPonatic S-Q31A&B,S-Q36A
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T, 12-P
Qualification	CE

S3360E HPV 15HR – 15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit

HPV Infections

Brief

15 High-risk HPV DNA Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of high-risk HPV (type 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) present in exfoliated cells from females’ cervix. The test results can be used as an aid in the diagnosis of a high-risk HPV infection.

Parameters

Product features	Parameter
Specimen Type	exfoliated cells from females’ cervix
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Detection types	type 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68
Internal Control	β--globin gene
PCR Instrument	ABI7500, QuantStudio 5, MA-6000, SLAN-96P, LightCycler 480, Stratagene Mx3000P, iPonatic S-Q31A&B,S-Q36A
Amplification Time	70 min
Sensitivity	1000 copies/mL
Spec.	48T, 12-P
Qualification	CE

S3027E HPV G15 – High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit

HPV Infections

Brief

This High-risk HPV DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing) is an in vitro nucleic acid amplification test for the detection of high-risk HPV (type 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) present in exfoliated cells from females’ cervix. The test results can be used for identification of HPV genotypes.

Parameters

Product features	Parameter
Specimen Type	Exfoliated cells from females’ cervix
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Detection types	type 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68
Internal Control	β--globin gene
PCR Instrument	SLAN-96P, ABI 7500, Roche LC 480 and QuantStudio^TM 5 , Stratagene Mx3000P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	24T/48T
Qualification	CE

S3057E HPV 13+2 – Human Papillomavirus DNA Diagnostic Kit

HPV Infections

Brief

Base on the study results by WHO International Agency for Research on Cancer (IARC) and other international organizations, the 13 kinds of genotypes including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 are classified as high-risk HPV, and the 5 kinds of genotypes including HPV26, 53, 66, 73, 82 are classified as medium-risk HPV. Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) chooses the above 13 kinds of high-risk genotypes and two popular kinds of medium-risk genotypes that are HPV 53 and 66 to be the target genotypes, in order to guarantee that the kit is capable of cervical carcinoma screening and risk evaluation. Moreover, it is clearly indicated that the females at the age of 30 or above who have no abnormal cervical cytology but the HPV detection is positive, especially for HPV16 and HPV18 infected females, should get vaginoscopy immediately. Therefore, the diagnostic kit can be used for detection of the 15 kinds of target genotypes and also subtype identification of HPV16 and HPV18.

Parameters

Product features	Parameter
Specimen Type	Exfoliated cells from females’ cervix
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Detection types	Type 16+18+31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68
Internal Control	β--globin gene
PCR Instrument	ABI7500, MA-6000, SLAN-96P, QuantGene 9600 , iPonatic S-Q31A&B, S-Q36A
Amplification Time	70 min
Sensitivity	1000 copies/mL
Spec.	48T, 24-P
Qualification	CE

S3002E HSV-2 – Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit

Reproductive Tract Infections

Brief

Herpes Simplex Virus Type 2 (HSV-2) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is used to detect the presence of HSV-2- DNA in samples such as male urethral swab and female cervical swab. The detection result can be used as an aid in the diagnosis of an HSV-2 infection. The test provides a molecular diagnostics-based solution for early diagnosis of venereal disease and for preliminary screening of high-risk venereal disease groups.

Parameters

Product features	Parameter
Specimen Type	Genital tract secretions.
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Target pathogen	HSV-2
Internal Control	Recombinant plasmid
PCR Instrument	ABI7500,QuantStudio 5, Stratagene Mx3000P, MA-6000, SLAN-96P, LightCycler® 480 II,iPonatic S-Q31A&B,S-Q36A
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T, 12-P
Qualification	CE

S3004E UU – Ureaplasma Urealyticum DNA Fluorescence Diagnostic Kit

Reproductive Tract Infections

Brief

The Ureaplasma Urealyticum (UU) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is used to detect the presence of UU-DNA in samples such as male urethra swab and female cervical swab. The detection result can be used as an aid in the diagnosis of a UU infection. The test provides a molecular diagnostics-based solution for early diagnosis of venereal disease and for preliminary screening of high-risk venereal disease groups.

Parameters

Product features	Parameter
Specimen Type	Genital tract secretions.
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Target pathogen	UU
Internal Control	Recombinant plasmid
PCR Instrument	ABI7500,QuantStudio 5, Stratagene Mx3000P, MA-6000, SLAN-96P, LightCycler® 480 II,iPonatic S-Q31A&B,S-Q36A
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T, 12-P
Qualification	CE

S3003E NG – Neisseria Gonorrhoeae DNA Fluorescence Diagnostic Kit

Reproductive Tract Infections

Brief

Neisseria Gonorrhoeae (NG) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) is used to detect the presence of NG-DNA in samples such as male urethral swab and female cervical swab. The detection result can be used as an aid in the diagnosis of an NG infection. The test provides a molecular diagnostics-based solution for early diagnosis of venereal disease and for preliminary screening of high-risk venereal disease groups.

Parameters

Product features	Parameter
Specimen Type	Genital tract secretions.
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Target pathogen	NG
Internal Control	Recombinant plasmid
PCR Instrument	ABI7500, QuantStudio 5, Stratagene Mx3000P, MA-6000, SLAN-96P, LightCycler® 480 II, iPonatic S-Q31A&B, S-Q36A
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T, 12-P
Qualification	CE

S3001E CT – Chlamydia Trachomatis DNA Fluorescence Diagnostic Kit

Reproductive Tract Infections

Brief

Chlamydia Trachomatis (CT) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) applies to detect CT DNA in specimens like reproductive tract secretion. The detection result can be used for aiding diagnosis of CT infection, which provides molecular diagnosis base for early diagnosis of venereal disease and for preliminary screening of venereal disease high-risk groups.

Parameters

Product features	Parameter
Specimen Type	genital tract secretions.
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Target pathogen	CT
Internal Control	Recombinant plasmid
PCR Instrument	ABI 7500, Roche LC480，Stratagene Mx3000P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T
Qualification	CE

S3050E CT/UU/NG – Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit

Reproductive Tract Infections

Brief

Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing) is a qualitative in vitro test for simultaneous detection of Chlamydia Trachomatis, Ureaplasma Urealyticum and Neisseria Gonorrhoeae DNA in sterile calcium alginate swab specimens from male urinary tract secretion and female genital tract secretion by applying real-time fluorescence quantitative PCR technique, which can provide molecular diagnosis evidence for the early diagnosis of related sexually transmitted diseases and initial screening of high-risk STD population.

Parameters

Product features	Parameters
Specimen Type	genital tract secretions.
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Target pathogen	CT, UU, NG-DNA
Internal Control	β--globin gene
PCR Instruments	ABI7500,SLAN-96P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T
Qualification	CE

S3113E SC2/FluA/B – SARS-CoV-2 and Influenza A/B Virus Nucleic Acid Diagnostic Kit

Respiratory Tract Infections

Brief

Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Elder people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness. Sansure COVID-19 diagnostic solutions are used to directly detect the presence of viral RNA, which will be detectable in patients before antibodies form or symptoms of the disease are present, which means the test results can tell whether or not that someone gets virus very early on in their illness. This kit can also joint-detect RNA of influenza A virus and influenza B virus.

Parameters

Product features	Parameters
Specimen Type	Oropharyngeal swab, sputum
Extraction Platform	One-tube fast release technology Advanced magnetic beads technology
Target Genes	SARS-CoV-2：ORF 1ab, N gene； influenza A：M gene； influenza B：NP gene
Internal Control	Rnase P gene
PCR Instrument	ABI7500, SLAN-96P, MA-6000, QuantGene 9600, iPonatic S-Q31A&B,S-Q36A
Sensitivity	200 copies/mL
Spec.	24T, 48T, 24-P
Qualification	CE

S3148E SC2/Flu/RSV – SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit

Respiratory Tract Infections

Brief

The SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time RT-PCR test intended for the qualitative Diagnostic of nucleic acid from SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple in the nasopharyngeal swabs and oropharyngeal swabs from individuals.

As the seventh coronavirus that infects humans, the SARS-CoV-2 can cause fever, fatigue, dry cough, dyspnea and other symptoms. In severe cases, it can cause acute respiratory distress syndrome, septic shock, and even death. At the same time, the SARS-CoV-2 has a strong spreading ability and has a wide range. Influenza virus (Influenza virus) can cause acute respiratory infections, with clinical manifestations of fever, headache, myalgia, fatigue, rhinitis, sore throat and cough. Influenza viruses can aggravate underlying diseases (such as heart and lung diseases) or cause secondary bacterial pneumonia or primary influenza viral pneumonia. The elderly and people with various chronic diseases or physical weakness are prone to severe complications and mortality higher after infecting influenza. Respiratory syncytial virus (RSV) belongs to the Pneumovirus genus of the Paramyxoviridae family. It mainly causes lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months, as well as rhinitis , Cold and other upper respiratory tract infections in older children and adults.

Parameters

Product features	Parameter
Covering pathogens	SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus
Specimen Types	Nasopharyngeal swab and oropharyngeal swab
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Internal Control	RNase P gene
Compatible Instrument	ABI 7500; MA-6000; SLAN®-96P; iPonatic S-Q31A/S-Q31B/S-Q36A
Sensitivity	500 copies/mL.
Qualification	CE

S3102E SC2 – Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit

Respiratory Tract Infections

Brief

COVID-19 is an infectious disease caused by a newly discovered coronavirus named SARS-CoV2. Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Elder people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness. Sansure COVID-19 diagnostic solutions are used to directly detect the presence of viral RNA, which will be detectable in patients before antibodies form or symptoms of the disease are present, which means the test results can tell whether or not that someone gets virus very early on in their illness.

Performance

One-tube/fast release technology
Up to 96 samples at one time
Simple operation process, less specialist training
Room temperature lysis, less contamination
Sampling types : nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, sputum, serum, whole blood ,Feces
Enhance large-scale screening efficiency
Internal control: human housekeeping gene RNase P

Parameters

Product features	Parameters
Specimen Type	Nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, sputum, serum, whole blood, feces
Extraction Platform	One-tube fast release technology Advanced magnetic beads technology
Internal Control	Rnase P gene
PCR Instrument	ABI7500, QuantStudioTM 5, SLAN-96P, MA-6000, Bio-Rad CFX-96, QuantGene 9600, LightCycler 480, iPonatic S-Q31A&B,S-Q36A
Sensitivity	200 copies/mL
Spec.	24T, 48T, 24-P
Qualification	CE

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S3121E SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay)
Respiratory Tract Infections
Brief

SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay) is intended for the qualitative detection of the SARS-CoV-2/InFluA/InFluB nucleocapsid protein in human nasopharyngeal or oropharyngeal swabs. Test results will be available for reading in 15-20 minutes. Positive results indicate the presence of viral antigens. This kit is for in vitro diagnostic use.

Features
- Accurate LOD 80TCID₅₀ /ml, Specificity 100%
- Convenient No instrument needed, easy to operate
- Fast Result available in only 15-20 min
Instruction

Result interpretation

Parameters

Qualification CE

Kit components

No. Product Name Spec.

S3121E-25

SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay)
25 Test

The kit components:
- SARS-CoV-2/InFluA/InFluB Antigen Test Cassette (individually in a foil pouch with desiccant)
- Sample Extraction Buffer
- Swab
Read More

No.	Product Name	Spec.
S3120E-1-H, S3120E-5-H	SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)	1 Test, 5 Tests

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References

[1]. Kozel TR, Burnham-Marusich AR. Point-of-care testing for infectious diseases: Past, present, and future. J Clin Microbiol 2017;55:2313-20.

[2]. Paige M.K. Larkin, Omai B. Garner. Molecular Point-of-Care Testing in Clinical Laboratories Laboratorians can lead a new era in rapid testing with expertise in quality control and result interpretation. Clinical Laboratory News. JUL.1.2020

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Extremely simple workflow

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