Comparison of the diagnostic accuracy of a rapid immunochromatographic test and the rapid plasma reagin test for antenatal syphilis screening in Mozambique.
OBJECTIVE
Programmes to control syphilis in developing countries are hampered by a lack of laboratory services, delayed diagnosis, and doubts about current screening methods. We aimed to compare the diagnostic accuracy of an immunochromatographic strip (ICS) test and the rapid plasma reagin (RPR) test with the combined gold standard (RPR, Treponema pallidum haemagglutination assay and direct immunofluorescence stain done at a reference laboratory) for the detection of syphilis in pregnancy.


METHODS
We included test results from 4789 women attending their first antenatal visit at one of six health facilities in Sofala Province, central Mozambique. We compared diagnostic accuracy (sensitivity, specificity, and positive and negative predictive values) of ICS and RPR done at the health facilities and ICS performed at the reference laboratory. We also made subgroup comparisons by human immunodeficiency virus (HIV) and malaria status.


RESULTS
For active syphilis, the sensitivity of the ICS was 95.3% at the reference laboratory, and 84.1% at the health facility. The sensitivity of the RPR at the health facility was 70.7%. Specificity and positive and negative predictive values showed a similar pattern. The ICS outperformed RPR in all comparisons (P<0.001).


CONCLUSIONS
The diagnostic accuracy of the ICS compared favourably with that of the gold standard. The use of the ICS in Mozambique and similar settings may improve the diagnosis of syphilis in health facilities, both with and without laboratories.
Montoya
Pablo J
PJ
Health Alliance International, Maputo, Mozambique. pablom@teledata.mz
Lukehart
Sheila A
SA
Brentlinger
Paula E
PE
Blanco
Ana J
AJ
Floriano
Florencia
F
Sairosse
Josefa
J
Gloyd
Stephen
S
D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D002845:Chromatography; D004396:Coloring Agents; D005260:Female; D016508:Fluorescent Treponemal Antibody-Absorption Test; D006801:Humans; D009073:Mozambique; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis* / Q000382:microbiology; D011296:Prenatal Diagnosis / Q000379:methods* / Q000592:standards; D011934:Reagent Strips; D011935:Reagins; D012680:Sensitivity and Specificity; D013587:Syphilis / Q000097:blood / Q000175:diagnosis* / Q000382:microbiology; D013588:Syphilis Serodiagnosis / Q000379:methods* / Q000592:standards; D014210:Treponema pallidum / Q000276:immunology
D000907:Antibodies, Bacterial; D004396:Coloring Agents; D011934:Reagent Strips; D011935:Reagins