Assessment of the implementation of HIV-rapid test kits at different levels of health institutions in Ethiopia.
OBJECTIVE
Evaluation and monitoring of Human Immunodeficiency Virus (HIV) testing reagents at the point of service is helpful to prevent the occurrence of problems related to testing and interpretation. To evaluate the implementation of HIV rapid test kits at the point of services in voluntarily counseling and testing (VCT) and diagnostic centers in Ethiopia.


METHODS
The assessment was the third phase of evaluation of HIV rapid test kits in Ethiopia followed from phase-I and phase-II. Known proficiency testing panels, well-structured questionnaire (addressing type of tests, human resource and problems related to tests), onsite supervision and retesting of samples collected from sites were used to evaluate the performances of reagents and laboratories.


RESULTS
Forty-four health institutions were included. Thirty-six (90.0%) health institutions had trained human resource on HIV testing. In 27 (61.4%) three types of HIV rapid test kits (Determine, Capillus and Unigold) were available. Serial-algorithm was used in all the laboratories. In 31 (70.4%) of them external quality control specimens were not used. Twenty two (50.0%) of the laboratories reported frequent shortage of reagents. All (100%) were able to identify negative specimens distributed. Positive proficiency panel samples were identified in 37 (94.8%) of the 39 laboratories. There was 98.3% agreement at a screening level between the sites and the central laboratory. Rate of discrepancy between screening and confirmatory assays was found to be 3.0% and 2.1% at the sites and at central laboratory, respectively.


CONCLUSIONS
The test kits showed a good performance at the point of services in the field sites. However, continuous assessment of HIV test kits at the point of service and training of professionals on newly arrived techniques are recommended to have effective testing performance with acceptable sensitive and specific testing algorithm. Effective quality assurance program should be in place to support programs such as VCT, prevention of mother-to-child-transmission and antiretroviral therapy.
Tegbaru
Belete
B
Ethiopian Health and Nutrition Research Institute (EHNRI)-National Referral Laboratory for AIDS (NRLA).
Wolday
Dawit
D
Messele
Tsehaynesh
T
Meless
Hailu
H
Kassa
Desta
D
Tesema
Desalegn
D
Tamene
Wogene
W
Ahmedin
Zinet
Z
Adane
Asfaw
A
Tebeje
Mekashaw
M
Gezahegn
Negussie
N
Birhanu
Hiwot
H
Mengistu
Yohannes
Y
Wuhib
Tadesse
T
Fekadu
Makonnen
M
D015492:AIDS Serodiagnosis; D000465:Algorithms; D003695:Delivery of Health Care; D005002:Ethiopia; D015483:HIV Antibodies / Q000276:immunology*; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology; D015528:HIV Seroprevalence; D015497:HIV-1; D019538:Health Care Surveys; D006801:Humans; D008403:Mass Screening; D011933:Reagent Kits, Diagnostic; D011795:Surveys and Questionnaires; D013997:Time Factors
D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic