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.