HIV Genotyping Assay (CE-IVD)

HIV Genotyping Assay (CE-IVD)

Clinical Research Services Contract NGS (Research Use Only)

Regulatory Status: CE-IVD, AUSTRALIA-IVD, HSA (Singapore)

DESCRIPTION

This assay is intended for the detection of HIV-1 Group M genomic mutations in Protease, Reverse Transcriptase and Integrase regions from plasma of patient specimens diagnosed with HIV infection.  HIV subtype determination in this assay is based on sequence information from two target regions, Protease and Reverse Transcriptase only and is not derived from full genome sequencing.

Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test.

 

SAMPLE REQUIREMENT

Minimum volume: 2 mL of serum or plasma

 

HIV Coverage

Target Genes

Codon Coverage

Targeted Mutations

Protease

1 – 99

97

Reverse Transcriptase

1 – 376

131

Integrase

1 – 288

48

 

Subtype Detection

A, B, C, D, F, G, H, J, K, AG,

CRF02, CRF03, CRF06, CRF09, CRF11, CRF13, CRF14, CRF18, CRF22, CRF25, CRF26, CRF37

 

TEST PERFORMANCE

Clinical sensitivity: 98.50%  (95% CI: 96.77% – 99.31%)

Variant detection correctness: 99.82% (95% CI: 99.78% – 99.86%)

Analytical sensitivity: 1000 copies/mL

Minimum variant frequency detected at 1000 copies/mL: 20%

Analytical reactivity: 97.43% (95%CI: 91.12%-99.29%)