Background:
Nucleic acid amplification technology is widely accepted as the standard of care for diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infections. An integral aspect associated with the implementation of molecular diagnostic assays is the development of appropriately rigorous methods for quality control within the testing laboratory. Under the Clinical Laboratories Improvement Amendments (CLIA) program (42 CFR 493 - Final Rule), prior to reporting patient test results, each laboratory that introduces an unmodified, FDA-cleared or -approved system must demonstrate accuracy and precision that are similar to the performance specifications established by the manufacturer. Due to the low prevalence of many analytes and a lack of independently confirmed positive specimens, this frequently presents a significant challenge and necessitates the use of seeded samples and/or commercially available mock specimens to demonstrate the adequacy of assay performance.

Objective:
To investigate the compatibility of Boston Biomedica ACCURUN® 341 and Bio-Rad Amplichek CT/GC DNA Swab and Urine Positive Controls with the BD ProbeTec ET CT/GC/AC Amplified DNA Assays.

Method:
Mock Swabs: 100µL aliquots of the ACCURUN-341 and Amplichek Swab Controls were diluted in 2mL of Diluent and assayed.
Mock Urines: 4mL volumes of PBS/BSA were spiked with 100µL aliquots of the ACCURUN-341 and Amplichek Urine Controls, processed and assayed.


Result:
For CT, the proportion of positive results was between 97% and 100% for Amplicheck and 90 and 100% for ACCURUN controls. For GC, both types of control yielded 100% positive results.

Conclusion:
ACCURUN-341 and Amplichek Swab and Urine Controls are compatible with the BD ProbeTec ET CT/GC/AC Amplified DNA Assays.

Implications:
The availability of these controls provides an independent means by which to monitor the performance of the BD ProbeTec ET CT/GC/AC Assays in accordance with CLIA guidelines.