C003E BCI – Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2)

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