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Simple/rapid test devices for anti-HIV screening: do they come up to the mark?
Giles RE; Perry KR; Parry JV; Medical Devices Agency Evaluation Centre,
December 30, 1999
J Med Virol. 1999 Sep;59(1):104-9. Unique Identifier : AIDSLINE

Thirteen simple/rapid test devices (S/RTDs) for the detection of antibodies to HIV 1 and HIV 2 were assessed. Ninety-two specimens in four categories were used and results with the thirteen S/RTDs were compared with those obtained with six currently available commercial laboratory-based anti-HIV 1/2 EIAs. Seven of the 13 S/RTDs scored all 26 blood donors' specimens as unreactive, and 11 correctly identified all the 25 "straightforward" anti-HIV positive specimens. False negative results arose when testing by Uni-Gold HIV and SeroCard HIV, which gave 72 and 68 correct positive observations, respectively, out of 75. No S/RTD detected seroconversion earlier than the most sensitive EIAs, but four S/RTDs performed similarly to most of the EIAs. On the low-titre panel specimens, six S/RTDs were less sensitive than the least sensitive EIA and, in contrast to four of the six EIAs, only one S/RTD was able correctly to identify all the positive specimens. A manufacturing problem was identified that allowed the HIV antigen-sensitised area on the membrane of two SeroCard HIV devices to be misaligned with the device's reading window so that the reaction was almost entirely obscured. As long as small numbers of specimens were involved, most S/RTDs required considerably less time and less equipment than EIAs, but overall they were slightly less sensitive. Their use in various health settings and for confirmatory procedures is discussed.

JOURNAL ARTICLE Developing Countries Evaluation Studies Human HIV Antibodies/*BLOOD HIV Infections/*DIAGNOSIS HIV-1/*IMMUNOLOGY HIV-2/*IMMUNOLOGY Immunoenzyme Techniques Mass Screening Predictive Value of Tests *Reagent Kits, Diagnostic Sensitivity and Specificity Support, Non-U.S. Gov't Time Factors