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AffirPrime HIV1&2/HBV/HCV
Intended Use

This assay is intended for the in vitro qualitative measurement of Hepatitis B virus (HBV) DNA, Hepatitis C virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 and 2(HIV 1 + 2) RNA in human serum or plasma samples. This assay is used for donor screening and as an auxiliary diagnosis for clinical infections of Hepatitis B virus, Hepatitis C virus and Human Immunodeficiency Virus Type 1 and 2.

Features

High-Efficiency Multiplexing

Simultaneously detects HBV DNA, HCV RNA, and HIV-1/2 RNA in a single reaction tube, significantly streamlining laboratory workflows and saving turnaround time.


Maximized Blood Safety

Specifically designed and optimized for reliable donor screening, providing an essential diagnostic layer to secure the blood supply chain.


Robust Internal Control

Utilizes advanced Armored RNA technology as a universal internal standard to prevent false negatives caused by RNA degradation or PCR inhibition.


Advanced Anti-Contamination

Incorporates a UNG enzyme system with dUTP to actively eliminate carryover contamination, ensuring high-confidence screening results.


Specifications

Product Name

AffirPrime HIV1&2/HBV/HCV

Technology / Methodology

Multiplex Real-Time PCR / Magnetic beads extraction

Specimen Type

Serum, Plasma (EDTA, Sodium Citrate)

Intended Use

Donor screening and auxiliary diagnosis

Target Pathogens

HBV DNA, HCV RNA, HIV-1/2 RNA

Fluorescence Channels

FAM (HBV), VIC (HCV), ROX (HIV-1+2), CY5 (IC)

LoD

HBV DNA: 5 IU/mL

HCV RNA: 10 IU/mL

HIV (1+2) RNA: 50 IU/mL

Internal Control

Yes

Storage Conditions

2-8°C

Shelf Life

12 months


Ordering Information

Catalog. No.

Product Name

Spec.

Certificate

M1051

AffirPrime HIV1&2/HBV/HCV

96 Tests/Kit

NMPA