Comparison of 4th-Generation HIV Antigen/Antibody Combination Assay With 3rd-Generation HIV Antibody Assays for the Occurrence of False-Positive and False-Negative Results.
OBJECTIVE
To assess the false-positive and false-negative rates of a 4th-generation human immunodeficiency virus (HIV) assay, the Abbott ARCHITECT, vs 2 HIV 3rd-generation assays, the Siemens Centaur and the Ortho-Clinical Diagnostics Vitros.


METHODS
We examined 123 patient specimens. In the first phase of the study, we compared 99 specimens that had a positive screening result via the 3rd-generation Vitros assay (10 positive, 82 negative, and 7 indeterminate via confirmatory immunofluorescent assay [IFA]/Western blot [WB] testing). In the second phase, we assessed 24 HIV-1 RNA-positive (positive result via the nuclear acid amplification test [NAAT] and negative/indeterminate results via the WB test) specimens harboring acute HIV infection.


RESULTS
The 4th-generation ARCHITECT assay yielded fewer false-positive results (n = 2) than the 3rd-generation Centaur (n = 9; P = .02) and Vitros (n = 82; P <.001) assays. One confirmed positive case had a false-negative result via the Centaur assay. When specimens from the 24 patients with acute HIV-1 infection were tested, the ARCHITECT assay yielded fewer false-negative results (n = 5) than the Centaur (n = 10) (P = .13) and the other 3rd-generation tests (n = 16) (P = .002).


CONCLUSIONS
This study indicates that the 4th-generation ARCHITECT HIV assay yields fewer false-positive and false-negative results than the 3rd-generation HIV assays we tested.
Department of Pathology, University of Texas Southwestern Medical Center at Dallas.
Alagarraju
A
Muthukumar
Department of Pathology, University of Texas Southwestern Medical Center at Dallas.
Adnan
A
Alatoom
Department of Pathology, University of Texas Southwestern Medical Center at Dallas.
Susan
S
Burns
Department of Pathology, University of Texas Southwestern Medical Center at Dallas.
Jerry
J
Ashmore
Department of Immunology, Parkland Memorial Hospital, Dallas, Texas.
Anne
A
Kim
Dallas County Health and Human Services, Dallas, Texas.
Brian
B
Emerson
Dallas County Health and Human Services, Dallas, Texas.
Edward
E
Bannister
Department of Pathology, University of Texas Southwestern Medical Center at Dallas Current affiliation: Department of Clinical Pathology, Cleveland Clinic, Cleveland, Ohio ansarim@ccf.org.
M Qasim
MQ
Ansari
D003955:Diagnostic Tests, Routine / Q000379:methods*; D005189:False Positive Reactions; D005260:Female; D015483:HIV Antibodies / Q000097:blood*; D015488:HIV Antigens / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008297:Male; D012698:Serologic Tests / Q000379:methods
D015483:HIV Antibodies; D015488:HIV Antigens
3rd-generation HIV assays; 4th-generation HIV testing; HIV; Western blot; false-negative results; false-positive results