An Assessment of the Current Chlamydia trachomatis Laboratory Practices in Germany

Abstract

Background and Objectives:

Currently, no information is available about the number of Chlamydia trachomatis (CT) tests performed, testing facilities available or diagnostic methods used in Germany. This study aimed to map CT diagnostic facilities so that representative laboratories can be recruited for CT sentinel surveillance.

Methods:

Using a questionnaire, we collected information about population coverage, the number of tests performed, accreditation and current testing methods and systems for German facilities that potentially offer CT diagnostics.

Results:

Overall, 725/1 504 (48%) facilities responded; of the respondents, 143 reported that they perform CT diagnostics. Of the laboratories performing diagnostics, 45% were privately owned, and 42% were located in a hospital. Of the laboratories that provided information about their catchment area, 61% received samples from at least one federal state and therefore covered more than their surrounding area. The median length of time that CT diagnostics had been performed was 11.5 years. Over half (54%) of the laboratories that provided information on their accreditation status were accredited, for a median duration of 6 years. In accordance with national guidelines, 77% used nucleic acid amplification tests (NAAT) for acute CT infections.

Conclusions:

The long duration since Ct diagnostics have been performed and laboratories have been accredited can be seen as an indication of the high diagnostic quality of German laboratories. Additionally, laboratories mostly serviced doctors and patients from a large region and are not representative for people living in the area where the lab is located. This has to be considered when sampling representative labs for CT sentinel surveillance and further epidemiological studies.

Zusammenfassung

Ziel der Studie:

Derzeit gibt es nur wenig Informationen über derzeit übliche Untersuchungspraktiken zur Diagnostik von Chlamydia trachomatis (CT) Infektionen in Deutschland. Um Sentinel-La­bore für ein bundesweites CT-Laborsentinel aus­wählen zu können, war die Basisinformation zur regionalen Verteilung der Labore, dem Einzugsgebiet und den aktuellen Praktiken unumgänglich.

Methodik:

Mittels eines Fragebogens wurden Informationen über die geografische Abdeckung, die Anzahl der durchgeführten CT-Tests, Akkreditierung und die aktuell verwendeten Test­methoden und Testsysteme in deutschen Diagno­stikeinrichtungen erhoben.

Ergebnisse:

Insgesamt nahmen 725 der 1 504 kontaktierten Einrichtungen (48%) teil; von diesen boten 143 CT-Diagnostik an. Von den Laboren mit CT-Diagnostik waren 45% in privater Hand und 42% an einem Krankenhaus organisiert. Von den La­boren, die Angaben zum Einzugsgebiet ihrer ­CT-Proben machten, erhielten 61% Proben aus mindestens einem Bundesland und deckten somit mehr als nur ihre direkte Umgebung ab. Die CT-Diagnostik wurde im Median seit 11,5 Jahren durchgeführt. Mehr als die Hälfte (54%) der Labore waren akkreditiert, im Median seit 6 Jahren. In Übereinstimmung mit den ­Richtlinien verwendeten 77% Nukleinsäureamplifikationstests (NAAT) zur Diagnose akuter Ct-Infektionen.

Schlussfolgerung:

Der lange Zeitraum seitdem die CT-Diagnostik durchgeführt wurde und Akkreditierungen vorlagen sprechen für weitreichende Erfahrung und einen hohen diagnostischen Qualitätsstandard in deutschen Laboratorien. Labore mit CT-Diagnostik deckten meist ein größeres Einzugsgebiet ab und arbei­teten überregional, was bei der Interpretation der Daten aus diesen Laboren und der Auswahl von repräsentativen Laboren für das CT-Labor­sentinel und weitere epidemiologische Studien berücksichtigt werden muss.

Key words

Chlamydia trachomatis (CT) - sexually transmitted ­infection (STI) - sentinel - Germany - nucleic acid amplification test (NAAT) - laboratory

Schlüsselwörter

Chlamydia trachomatis (CT) - sexuell übertragbare ­Infektion (STI) - Sentinel - Deutschland - Nukleinsäureamplifikations­test (NAAT) - Labor

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