Field evaluation of the Merlin immediate HIV-1 and -2 test for point-of-care detection of human immunodeficiency virus antibodies.
The Merlin Immediate HIV-1 and -2 Test (Merlin point-of-care [POC] test; Merlin Biomedical & Pharmaceutical) is a nitrocellulose membrane flow immunoassay performed at the POC with the use of blood obtained from a fingerprick. The results of this test were compared with those of enzyme immunoassay (EIA) performed on venous blood samples in the laboratory. Positive results of both tests were confirmed by a Western blot (WB). The study included 553 adults with known HIV (human immunodeficiency virus) seropositivity (all of whom had positive Merlin POC test results) and 2659 adults with unknown HIV serostatus (20 of whom had positive EIA/WB results; 19 of the 20 also had positive Merlin-POC test results). The sensitivity of the Merlin POC test was 95.0% for patients with an unknown HIV serostatus and 99.83% for those with a positive serostatus. For previously untested subjects, the test's specificity and positive predictive value were 100%, its negative predictive value was 99.96%, and its overall accuracy was 99.96%. The Merlin POC test is highly accurate for the detection of HIV antibodies.
Shafran
Stephen D
SD
Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2B7. sshafran@uah.ualberta.ca
Conway
Brian
B
Prasad
Errol
E
Greer
Jane
J
Vincelette
Jean
J
Ellis
C Edward
CE
Haase
David A
DA
Walmsley
Sharon L
SL
Lalonde
Richard G
RG
Cameron
D William
DW
D015492:AIDS Serodiagnosis / Q000379:methods*; D000328:Adult; D000914:Antibodies, Viral / Q000276:immunology; D015153:Blotting, Western; D006679:HIV Seropositivity; D015497:HIV-1 / Q000276:immunology / Q000302:isolation & purification*; D015498:HIV-2 / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D000914:Antibodies, Viral; D011933:Reagent Kits, Diagnostic