Reduced community access to a key contraceptive: public health consequence from false suspicion of HIV-contaminated injectables.
BACKGROUND
This study was conducted to investigate a report of positive test results with DMPA on an HIV rapid test. Suspecting HIV contamination, the Zambian Ministry of Health initiated a product withdrawal pending full evaluation.


METHODS
DMPA was evaluated for compliance to product specifications. Contamination with HIV and blood components was investigated with PCR and human IgG ELISA. The performance of Genie II, Unigold and Determine HIV rapid tests was evaluated using DMPA.


RESULTS
DMPA was found compliant with product specifications and negative for HIV and human IgG. DMPA impaired the performance of HIV rapid tests resulting in false-positive/indeterminant results. Rapid test results using polysorbate 80 (formulation component of DMPA) mimicked results obtained with DMPA.


CONCLUSIONS
The DMPA sample was negative for HIV and human IgG. Formulation components may have led to the interpretation of false-positive results, reinforcing the need to validate the sample type used in any test. DMPA use was reinstated in Zambia, minimizing the public health impact that resulted from the initial rapid test results.
Jenkins
David W
DW
Product Quality and Compliance, Family Health International, Durham, NC 27713, USA. djenkins@fhi.org
Krysiak
Robert
R
Sexton
Connie
C
D003278:Contraceptives, Oral, Hormonal / Q000592:standards*; D004279:DNA, Viral / Q000737:chemistry / Q000235:genetics; D004340:Drug Contamination; D005189:False Positive Reactions; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D017258:Medroxyprogesterone Acetate / Q000592:standards*; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015024:Zambia
D003278:Contraceptives, Oral, Hormonal; D004279:DNA, Viral; D007074:Immunoglobulin G; D011933:Reagent Kits, Diagnostic; D017258:Medroxyprogesterone Acetate