Comparison of the Sanofi Diagnostics Pasteur Chlamydia Microplate EIA shortened assay with the original standard assay and cell culture.
The new Sanofi Diagnostics Pasteur Chlamydia Microplate EIA shortened assay was evaluated by comparison with the original standard assay and cell culture. A total of 853 paired male and female genital tract specimens was tested with both Sanofi Chlamydia Microplate EIA shortened and standard assays and the results were compared with those of cell culture. For confirmation, a blocking assay run in the shortened format was used. Discrepancies between the three methods were resolved by a direct fluorescent antibody (DFA) test on the EIA samples or the culture retentate, or both. After resolution of discrepant results, the standard assay had a sensitivity, specificity, positive predictive value and negative predictive value of 98.5%, 100%, 100% and 99.9%, respectively. The shortened assay results were 100%, 100%, 100% and 100%, respectively. The shortened assay takes approximately 1.5 h less time than the standard assay and this study demonstrated that they have equivalent sensitivity and specificity. The improvement in turnaround time enables results to be reported on the same day.
Chan
E L
EL
Department of Clinical Microbiology, Provincial Laboratory, Regina, Saskatchewan, Canada.
Brandt
K
K
Stoneham
H
H
Horsman
G
G
D002478:Cells, Cultured; D002690:Chlamydia Infections / Q000175:diagnosis*; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D019085:Fluorescent Antibody Technique, Direct; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013997:Time Factors
D011933:Reagent Kits, Diagnostic