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, Roche LC480 and Stratagene Mx3000P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T

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 and18) DNA in reproductive tract secretions. It is intended for use as an aid in the diagnosis of an HPV (Type 16 and18) 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, Roche LC480 and Stratagene Mx3000P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	48T

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 QuantStudioTM 5 , Stratagene Mx3000P
Amplification Time	70 min
Sensitivity	400 copies/mL
Spec.	24T/48T

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 ,SLAN-96P
Amplification Time	70 min
Sensitivity	1000 copies/mL
Spec.	48T