RESUMO
This study to evaluate the performance of eight diagnostic tests for HIV/AIDS infection was conducted at the National Reference Center for HIV/AIDS/STD in Lomé, Togo. The tests were as follows: Enzymum test anti HIV Combi, Enzymum tests anti-HIV1 + 2 + subtype O, Genscreen HIV 1/2, Ice 1.0.2, Vironostika HIV Uni-Form II Plus O, Genie II HIV 1/2, SFD HIV 1/2 PA and DETERMINE HIV 1/2. A total of 238 serum specimens collected consecutively between January and April 1999 were studied. They were from 161 occasional blood donors and 77 patients. New Lav-Blot I and Ii (western blot) were used as reference tests. Test sensitivity ranged from 90 to 100%. Specificity ranged from 96 to 100%. The Enzymum test anti HIV Combi used only on serum samples from blood donors demonstrated a sensitivity and specificity of 100%. Tests based on Elisa (Emzymum Combi, Enzymum HIV 1 + 2 + subtype O, Genscreen, Ice 1.0.2 and Vironostika) allowed acceptable diagnosis of HIV/AIDS as alternatives to western blot. Two of the three rapid assays tested provided acceptable results, i.e., Genie II HIV 1/2 and SFD HIV 1/2. They are suitable for screening to prevent HIV transmission by blood transfusion in areas where Elisa is unfeasible.
Assuntos
Infecções por HIV/diagnóstico , Transfusão de Sangue , Western Blotting , DNA Viral/análise , Ensaio de Imunoadsorção Enzimática , Humanos , Controle de Qualidade , Sensibilidade e Especificidade , TogoRESUMO
PURPOSE: HIV rapid diagnostic tests (RDT) could be greatly contributive for a universal access to HIV diagnosis. However, according to the WHO, these tests need to be assessed before they can be used in routine. METHOD AND RESULTS: We assessed 9 RDT in routine clinical use between 2009 and 2013. The sensitivity and specificity observed for 7 tests were≥99% and≥98%, respectively: FIRST RESPONSE HIV1-2-O PMC Medical, India, GENIE Fast HIV 1-2 and GENIE™ III HIV(1/2) Bio-Rad, France, HIV TRI-DOT+Ag;J. Mitra, INDIA; SD BIOLINE HIV(1/2) 3.0 and SD BIOLINE HIV/SYPHILIS DUO Standard Diagnostic, Korea; and VIKIA HIV(1/2); BioMérieux, France. Two tests had performances inferior to WHO recommendations: INSTI HIV1/2 Biolytical Canada; sensitivity=97.8% and HEXAGON HIV HUMAN GmbH Germany; specificity=94.8%. CONCLUSION: Seven of 9 RDT had excellent performances. Nevertheless, they can be used only after training staff, and taking into account national algorithm for their safe use.