Quality Assessment Of Serological Testing For Syphilis In Shanghai Clinical Laboratories

Syphilis is a chronic sexually transmitted diseases caused by treponema, which is usually acquired by sexual contact. The increased prevalence of syphilis has become a serious social problem in recent years.The diagnosis of syphilis is based on the clinical history, clinical symptoms and laboratory test. Laboratory test is important to diagnosis, treatment and effectiveness evaluation, so the accuracy of laboratory test is also important.Syphilis serological testing is the main laboratory test, included nontreponemal screening tests (RPR, TRUST) and treponemal final diagnosis tests (TPPA).To now, there is no report about the lab quality of serological testing in shanghai, This study investigated several lab quality of serological testing, then analysis the influence factors and propose improvement measures to improve the lab quality of serological testing in shanghai.PART1Survey the 59 labs quality of nontreponemal screening tests for syphilis by field hospital and central hospitalObjective:Survey the 59 labs quality of nontreponemal screening tests for syphilis, then evaluate the influence factors. Methods Analysis the influence factors by field survey 59 labs of syphilis to hospital and central hospital in October 2004. Issuing quality-control syphilis serum samples to hospital, they detected it and send report to us, we analysis the influence factors by field survey 59 labs of tertiary hospital and central hospital. Results Before the improved methods were applied, the overall lab up-to-standard rate is 89.85% in nontreponemal screening tests of field survey 59 labs. The instruments for syphilis screening test are only 40 (67.8%). The regent for syphilis screening are 48(98.9%) qualified and personnel qualifications are all qualified. The quality of horizontal rotor is a influence factor to up-to-standard rate (χ2=7.11, p=0.03). for tertiary hospital and central hospital, the difference of titre results between reagents is significant in higher titre samples (F=4.498, p=0.038). Conclusion The 59 labs nontreponemal screening tests for syphilis is in good condition in shanghai. The difference of titre results between reagents is significant in higher titre samples. The quality of horizontal rotor is a influence factor to up-to-standard rate.PART2Quality assessment of Serological testing for syphilis in Shanghai Clinical LaboratoriesObjective:Investigate the overall labs quality of serodiagnosis, then evaluate the influence factors and improve the overall quality of serodiagnosis in shanghai.Methods Get the overall quality status of serodiagnosis with quality control in 2006. From 2006 to 2007, the improved methods were applied in labs. Two stage's results was compared to evaluate the improved methods. Results The up-to-standard rates in three years of were 73%,83.1%,85.2%(screen tests) and 93.5%,95.4%,99.1% (final diagnosis tests). The up-to-standard rates of nontreponemal screening tests increased in primary hospitals and secondary hospitals (p=0.019, p=0.020). The overall up-to-standard rates increased after first improvement. There is no change of treponemal final diagnosis tests (p=0.065,p=0.550). The up-to-standard rates of final diagnosis tests is higher than screening tests (p=0.000). The up-to-standard rates increased in negative and lower titre samples after first and second improvement.Conclusion In shanghai, the overall quality of serodiagnosis is good, the quality of treponemal tests is better than nontreponemal tests.There is defects in screening tests, especially in lower titre samples. Improved methods led to a better quality of serodiagnosis partly.