TY - JOUR
T1 - Low specificity of HIV-testing on sputum specimens kept at ambient temperatures for 4 to 7 days: a blinded comparison
AU - Egwaga, Saidi M.
AU - Chonde, Timothy M.
AU - Matee, Mecky I.
AU - Mfinanga, Sayoki G.
AU - Ngowi, Prosper E.
AU - Lwilla, Fred
AU - Cobelens, Frank Gj
PY - 2007
Y1 - 2007
N2 - ABSTRACT: BACKGROUND: HIV testing on sputum using the QraQuick HIV1/2(R) assay has high sensitivity and specificity, and holds promise for application in tuberculosis surveys. Its performance under conditions that may occur during surveys in resource-poor countries is however, unknown. We assessed, in a blinded comparison with HIV serum testing, the sensitivity and specificity of the OraQuick(R) assay for detecting HIV antibody in sputum specimens kept at ambient temperature for up to 7 days, with and without decontaminant. METHODS: Paired sputum and blood specimens from consecutively diagnosed smear-positive tuberculosis patients were tested with OraQuick(R) and 2 HIV-1/2 ELISA's. Sputum was tested within 24 hours of collection, split into 2 aliquots with and without addition of cetylpyridium chloride, and tested again after 4 and 7 days. RESULTS: Complete data was available for 377/435 (87%) enrolled patients; 132 (35%) tested HIV positive on serum. The sensitivity of the sputum test was 94.7% (95% CI 89.4-97.8) on day 1, 93.2% on day 4 and 92.9% on day 7. The specificity was 92.9% (95% CI 88.9-95.8) on day 1, and declined to 76.7% on day 4 (p <0.001) and to 62.7% on day 7 (p <0.001). Adding cetylpyridium chloride further decreased the specificity to 67.8% on day 4 (p = 0.04) and to 49.6% on day 7 (p = 0.004). CONCLUSION: Transportation of sputum specimens at ambient temperatures for 4 days or more, and addition of decontaminant, strongly affect the specificity of the OraQuick(R) assay. Unless applied within one day, this assay is not suitable for estimation of HIV-prevalence among tuberculosis patients in survey settings
AB - ABSTRACT: BACKGROUND: HIV testing on sputum using the QraQuick HIV1/2(R) assay has high sensitivity and specificity, and holds promise for application in tuberculosis surveys. Its performance under conditions that may occur during surveys in resource-poor countries is however, unknown. We assessed, in a blinded comparison with HIV serum testing, the sensitivity and specificity of the OraQuick(R) assay for detecting HIV antibody in sputum specimens kept at ambient temperature for up to 7 days, with and without decontaminant. METHODS: Paired sputum and blood specimens from consecutively diagnosed smear-positive tuberculosis patients were tested with OraQuick(R) and 2 HIV-1/2 ELISA's. Sputum was tested within 24 hours of collection, split into 2 aliquots with and without addition of cetylpyridium chloride, and tested again after 4 and 7 days. RESULTS: Complete data was available for 377/435 (87%) enrolled patients; 132 (35%) tested HIV positive on serum. The sensitivity of the sputum test was 94.7% (95% CI 89.4-97.8) on day 1, 93.2% on day 4 and 92.9% on day 7. The specificity was 92.9% (95% CI 88.9-95.8) on day 1, and declined to 76.7% on day 4 (p <0.001) and to 62.7% on day 7 (p <0.001). Adding cetylpyridium chloride further decreased the specificity to 67.8% on day 4 (p = 0.04) and to 49.6% on day 7 (p = 0.004). CONCLUSION: Transportation of sputum specimens at ambient temperatures for 4 days or more, and addition of decontaminant, strongly affect the specificity of the OraQuick(R) assay. Unless applied within one day, this assay is not suitable for estimation of HIV-prevalence among tuberculosis patients in survey settings
U2 - https://doi.org/10.1186/1472-6890-7-8
DO - https://doi.org/10.1186/1472-6890-7-8
M3 - Article
C2 - 17880720
SN - 1472-6890
VL - 7
SP - 8
JO - BMC clinical pathology
JF - BMC clinical pathology
ER -