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Validation of the Roche COBAS Amplicor system for Chlamydia trachomatis
J M Matthews-Greer1, K L McRae, E B LaHaye
1Diagnostic Virology Laboratory, Louisiana State University Health Sciences Center at Shreveport, 1501 Kings Highway, Shreveport, LA 71130-3932, USA. jgreer@lsuhsc.edu
Summary
This study validated the Roche Amplicor polymerase chain reaction (PCR) for chlamydia detection. PCR offers increased detection rates but requires longer preparation and is not licensed for ocular specimens.
Area of Science:
- Clinical microbiology
- Infectious diseases
Background:
- Chlamydia trachomatis infections are a significant public health concern.
- Accurate and efficient diagnostic methods are crucial for timely treatment and prevention of complications.
Purpose of the Study:
- To validate the Roche Amplicor polymerase chain reaction (PCR) assay using the COBAS automated analyzer for detecting Chlamydia trachomatis.
- To compare the performance of PCR with the Enzyme Immunoassay (EIA) method.
Main Methods:
- Endocervical swab specimens from 193 women were tested using both EIA (MicroTrak Chlamydia Kit) and PCR (Roche Amplicor on COBAS).
- Specimens were collected from patients attending Women's Health, Primary Care, Obstetrics and Gynecology, and Family Practice clinics.
Main Results:
- PCR detected a higher number of chlamydia infections compared to EIA.
- Of 193 specimens, 26.4% tested positive by either method or PCR alone. 14.5% were positive by both, and 11.9% were positive by PCR only.
- PCR reproducibility was 88.2% for repeat testing of positive specimens.
Conclusions:
- The Roche Amplicor PCR assay, when used with the COBAS system, can significantly increase chlamydia detection rates in the studied population.
- Drawbacks include longer specimen preparation time than EIA and lack of licensing for ocular specimens.
- Culture remains necessary for medicolegal cases and suspected sexual abuse due to limitations of both EIA and PCR.