Laboratory improvement in the CDC proficiency testing program

Is Serological Testing a Reliable Tool in Laboratory Diagnosis of Syphilis? Meta-Analysis of Eight External Quality Control Surveys Performed by the German Infection Serology Proficiency Testing Program

“…The quality of routine serological diagnosis of syphilis, however, has been questioned by several studies that found significant inter-and intralaboratory variability of test results (11,12,15,20,21,22). In the United States, the Food and Drug Administration (FDA) and the Center for Devices and Radiological Health enforce a complex regulatory system for new in vitro diagnostics (8).…”

“…Guidelines for acceptance and evaluation of new syphilis tests (2) as published by the CDC (Centers for Disease Control and Prevention), the regular participation of diagnostic laboratories in proficiency testing, and the establishment of medical advisory boards for the diagnosis of syphilis represent internationally proven interventions for achieving better test standardization and for regulating the quality of infection serology in general (12,15,20,21,22). Over the years, the success of such policy options is strongly supported by the results of quality assessment schemes in other countries, including the United Kingdom, Taiwan, and the United States, where the performance of laboratories could be improved, particularly when guidance was provided to poorly performing laboratories (11,20,21,22).…”

“…Over the years, the success of such policy options is strongly supported by the results of quality assessment schemes in other countries, including the United Kingdom, Taiwan, and the United States, where the performance of laboratories could be improved, particularly when guidance was provided to poorly performing laboratories (11,20,21,22). In addition, the use of standard preparations can increase accuracy levels Ն10% (21,22). Such interventions were successful in parameters like rheumatoid factor, parvovirus B19 serology, Lyme disease serology, and tick-borne encephalitis ELISA testing (3,7,10,21,22).…”

“…In addition, the use of standard preparations can increase accuracy levels Ն10% (21,22). Such interventions were successful in parameters like rheumatoid factor, parvovirus B19 serology, Lyme disease serology, and tick-borne encephalitis ELISA testing (3,7,10,21,22). To improve the quality of syphilis serology in Germany and possibly in Europe, a network of independent specialist laboratories should deal with the issues of test evaluation, quality promotion, and interassay standardization of commercially available test kits on a more regular basis.…”

“…The accuracy of diagnostic tests is critical for successful control measures of epidemic syphilis outbreaks, including case finding, prompt therapy of infected individuals, and mandatory testing of potential transmitters (2,4,9,14). Thus, promotion and quality control of diagnostic procedures is a relevant public health issue, but peer reviewed publications on that topic are sparse (11,15,20,21,22). Here, for the first time, the impact of test quality on the laboratory diagnosis of syphilis in Germany is investigated by use of a meta-analysis of external quality control program data obtained between 2000 and 2003 by the The Bacteriologic Infection Serology Study Group of Germany (BISSGG) (12,13).…”