English Abstract A feasibility study on the possibilities of quality
assessment for PCR diagnostic tests for detection of Chlamydia trachomatis
was carried out among seven laboratories. Fifteen samples from patients,
i.e. six culture negative samples and three dilultion's of three
culture-positive samples, were mailed to and tested by the laboratories.
Four times they used an in house developed PCR test and five times the
commercially available AmplicorTM kit. With one exception, all negative
samples were correctly reported as negative. One sample was false-positive
reported by an in house developed PCR test. Nine times a false-negative
result was reported. Five samples were false negative in two of the in
house developed PCR tests. One PCR protocol appeared to be sub optimal and
one PCR test used as detection method of the amplicon gel electrophoresis
only, which is probably not sensitive enough. Three samples were reported
false negative by one laboratory using the AmplicorTM kit and one sample by
another laboratory. The cause appeared to be an inappropriate method of
sample preparation. Using an optimal protocol both in house developed PCR
tests and the commercially available AmplicorTM kit appear to be equally
sensitive. It was concluded, that PCR quality assessment by mailing
selected samples in dilution series is feasible.