Evaluation of Bio-Rad Geenius HIV-1 and -2 Assay as a Confirmatory Assay for Detection of HIV-1 and -2 Antibodies

DOI: 10.1128/CVI.00153-14

Article Figures & Data

TABLE 1

Comparison of results from the RIBA and Geenius HIV assays

Sample type and HIV status	n	No. with each RIBA result			No. with each Geenius result
Sample type and HIV status	n	Negative	Indeterminate	Positive	Negative	Indeterminate	Positive
Retrospective clinical samples^{^a}
HIV-1 positive	23	0	0	23	0	0	23
HIV-2 positive	1	0	0	1	0	0	1
HIV-1 and HIV-2 positive	1	0	0	1	0	0	1
HIV negative	25	25	0	0	24	1	0
Acute HIV infection^{^b}	5	0	5	0	2	1	2
Acute HIV seroconversion panel^{^b}
1:e sample	10	9	1	0	8	0	2
2:e sample	10	0	5	5	4	0	6
Prospective clinical samples	79	35	3	41	37	0	42
Total	154	69	14	71	75	2	77

↵a HIV status for the retrospectively analyzed positive samples was based on results from follow-up testing confirming HIV infection with RIBA or HIV RNA/DNA. HIV status for the retrospectively analyzed negative samples was based on negative results for both HIV antigen assay tests and follow-up tests. These include samples from 10 blood donors.
↵b Acute-phase HIV infection status was based on indeterminate or negative RIBA results, a positive HIV antigen assay result, and documented HIV seroconversion in follow-up samples.

TABLE 2

Results for seroconversion sample panel

Patient no.	Sample no.	Date (days^{^b})	Sample result^{^a}
Patient no.	Sample no.	Date (days^{^b})	HIV antigen	NT	RIBA	Geenius
1	1	0	Pos	Pos	Neg	Neg
	2	+4	Pos		Ind	Pos
2	1	0	Pos	Pos	Neg	Neg
	2	+7	ND		Pos	Pos
3	1	0	Pos	Pos	Neg	Neg
	2	+12	Pos		Pos	Pos
4	1	0	Pos	Pos	Neg	Neg
	2	+24	Pos		Pos	Pos
5	1	0	Pos	Pos	Neg	Pos
	2	+14	Neg		Pos	Pos
6	1	0	Pos	Pos	Neg	Neg
	2	+4	Pos		Pos	Neg
7	1	0	Pos	Pos	Neg	Neg
	2	+11	Pos		Ind	Neg
8	1	0	Pos	Pos	Neg	Neg
	2	+7	Pos		Ind	Neg
9	1	0	Pos	Pos	Neg	Neg
	2	+8	Pos		Ind	Neg
10	1	0	Pos	Pos	Ind	Pos
	2	+41	ND		Ind	Pos

↵a NT, neutralization test for confirmation of HIV antigen; Neg, negative; Ind, indeterminate; Pos, positive; ND, not done.
↵b Number of days between first and second samples.