Clinical specificity and sensitivity of a blood screening assay for detection of HIV-1 and HCV RNA.
BACKGROUND
An HIV-1 and HCV NAT blood screening assay (Procleix HIV-1/HCV, Gen-Probe, Inc.) simultaneously detecting HIV-1 and HCV RNA) has been implemented. Donor plasma samples reactive in the Procleix HIV-1/HCV assay are tested with the HIV-1 and HCV discriminatory assays to resolve whether HIV-1 RNA, HCV RNA, or both are present.


METHODS
To determine the specificity of the Procleix HIV-1/HCV assay, data were analyzed for samples from 192,288 donations, tested in 16-member pools. To determine sensitivity, data were analyzed for 2014 commercial samples known to contain HIV-1, HCV, or both, as well as 10 HIV-1 and 10 HCV commercial seroconversion panels.


RESULTS
The specificity of the Procleix HIV-1/HCV assay was 99.7 percent. The HIV-1 and HCV discriminatory assays showed similar specificity. The sensitivity of the Procleix HIV-1/HCV assay was 99.9, 99.6, and 100 percent, respectively, for samples containing HIV-1, HCV, or both. The Procleix discriminatory assays were comparably sensitive. The Procleix discriminatory assays detected all tested samples of known HIV-1 subtype or HCV genotype. Procleix HIV-1/HCV testing of seroconversion panels showed that the median times to a positive reaction for HIV-1 and HCV were reduced by 3 and 25 days, respectively, compared to serologic tests.


CONCLUSIONS
These studies support the use of the Procleix HIV-1/HCV assay for routine blood donor screening.
Vargo
Janet
J
Gen-Probe Incorporated, San Diego, California 92121, USA. janetv@gen-probe.com
Smith
Katie
K
Knott
Caroline
C
Wang
Songbai
S
Fang
Chyang
C
McDonough
Sherrol
S
Giachetti
Cristina
C
Caglioti
Sally
S
Gammon
Richard
R
Gilbert
Denise
D
Jackson
J Brooks
JB
Richards
William
W
Stramer
Susan
S
Mimms
Larry
L
D001769:Blood / Q000821:virology; D001782:Blood Donors; D005838:Genotype; D015658:HIV Infections / Q000175:diagnosis / Q000635:transmission; D006679:HIV Seropositivity; D015497:HIV-1 / Q000235:genetics*; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000175:diagnosis / Q000635:transmission; D006801:Humans; D008403:Mass Screening; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity
D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic