Clinical performance of HIV Ag/Ab diagnostic test

This study evaluated the clinical performance of the HIV Ag/Ab diagnostic test, designed for the qualitative detection of HIV p24 antigen and antibodies to HIV-1 and HIV-2 in human serum or plasma.

From the coordinator

The evaluation confirms the utility of the test as a reliable HIV diagnostic tool, compliant with the IVDR requirements.

PROJECT COORDINATOR Izabela
Chodara Director of Strategy and Operations

Challenges

The need to compare performance with a CE-marked reference test

Demonstrating reliability for all three analytes (HIV p24 antigen, HIV-1 antibodies, HIV-2 antibodies)

Description of the study

The objective of this clinical performance evaluation was to verify the HIV Ag/Ab diagnostic test, based on the CLIA method, designed for the qualitative detection of HIV p24 antigen and antibodies to HIV-1 and HIV-2 in human serum or plasma. The test was assessed in accordance with Regulation (EU) 2017/746 (IVDR), using residual serum and plasma samples.

The HIV Ag/Ab diagnostic test, classified as a class D in vitro diagnostic medical device, was evaluated against a CE-marked reference assay using a certified CLIA analyzer. The study focused on the detection of three analytes: HIV p24 antigen, anti-HIV-1 antibodies, and anti-HIV-2 antibodies.

The results demonstrated that the HIV Ag/Ab diagnostic test achieved clinical performance comparable to the reference method in terms of sensitivity and specificity. The kit met the standards set forth under the IVDR, confirming its value as a diagnostic tool for HIV detection.

Results

Effective detection of HIV p24 antigen, HIV-1 antibodies, and HIV-2 antibodies

Compliance with IVDR requirements for class D devices

Key findings

The HIV Ag/Ab test fulfilled the IVDR requirements, achieving diagnostic accuracy comparable to the reference method.

Izabela Chodara

Project Manager

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