English
Fourth-generation HIV immunoassays empower earlier viral detection—even during seroconversion—allowing for detection of earlier and established infections. And earlier detection allows for earlier treatment.
In this multicenter study, scientists evaluated the new Beckman Coulter Access HIV Ag/Ab combo assay, which simultaneously detects HIV-1 p24 antigen and HIV 1/2 antibodies on the DxI 9000 Immunoassay Analyzer, and compared it to two commercially available HIV assays on more than 9000 fresh and frozen blood samples, including more than 250 with potentially cross-reactive factors.
The Beckman Coulter Access HIV Ag/Ab combo assay showed:
- Excellent clinical performance on clinical samples and viral lysates
- 100% clinical sensitivity for clinical samples
- A higher sensitivity in 44 of the 46 lysates on the Access assay as compared with another commercially available assay
- >99% clinical specificity for testing of blood donor and hospitalized patient samples
- Exceptional analytical sensitivity on seroconversion samples and p24 antigen
- Detection of seroconversion 1 to 2 bleeds earlier than another commercially available assay
- Detection of the p24 antigen 1.2 and 1.6 days earlier compared with the two other commercially available assays
- A lower Limit of Detection (LoD) for the p24 antigen on the Access assay (0.22 IU/mL) than the reported value for either of the other two commercially available assays (0.7–1.2 IU/mL and 0.3 IU/mL)
- A higher number of detected bleeds with the Access assay than for either of the other two commercially available assays (n = 90 vs. n = 80 or n = 77)
