Reproducibility problems with the AMPLICOR PCR Chlamydia trachomatis test.
AUTOR(ES)
Peterson, E M
RESUMO
In an attempt to use an expanded "gold standard" in an evaluation of an antigen detection test for Chlamydia trachomatis, the AMPLICOR (Roche Diagnostics Systems, Inc., Branchburg, N.J.) PCR Chlamydia trachomatis test and culture were used with 591 sets of cervical specimens. Of the 591 specimens assayed, 35 were retested due to either an equivocal result by the PCR (19 samples) or a discrepancy between the results of culture, PCR, and the antigen detection method. During the repeat testing of the samples with equivocal and discrepant results, all but one interpretation change was due to the PCR result. In addition, upon repeat testing the PCR assay value measured in optical density units varied widely for 13 of these specimens. These 13 specimens were then tested in triplicate by the manufacturer with primers to the chlamydia plasmid and in duplicate with primers to the major outer membrane protein. Only 3 of the 13 specimens gave the same interpretation with these five replicates. In summary, reproducibility problems with the AMPLICOR test should be considered before it is incorporated as part of routine testing or used as an expanded gold standard for chlamydia testing.
ACESSO AO ARTIGO
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=229709Documentos Relacionados
- Reproducibility and performance of the AMPLICOR Chlamydia trachomatis test.
- Reproducibility of AMPLICOR enterovirus PCR test results.
- Reproducibility Problems with the Abbott Laboratories LCx Assay for Chlamydia trachomatis and Neisseria gonorrhoeae
- Differences in the sensitivity of the Amplicor Chlamydia trachomatis PCR assay.
- Multicenter Evaluation of the Fully Automated COBAS AMPLICOR PCR Test for Detection of Chlamydia trachomatis in Urogenital Specimens