Limitations

1. To ensure collection of cells infected with Chlamydia, columnar epithelial cells lining the endocervix should be sampled. If excess mucus is not removed, sampling of these cells is not ensured.
2. Reliable results are dependent on adequate specimen collection. Because the transport system used for this assay does not permit microscopic assessment of specimen adequacy, training of clinicians in proper specimen collection techniques is necessary. Refer to the package insert of the appropriate GEN-PROBE specimen collection kit.
3. Therapeutic failure or success cannot be determined with the APTIMA Combo 2 Assay since nucleic acid may persist following appropriate antimicrobial therapy
4. Results from the APTIMA Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.
5. A negative result does not preclude a possible infection because results are dependent on adequate specimen collection. Test results may be affected by improper specimen collection, technical error, specimen mix-up, or target levels below the assay limit of detection.
6. For the endocervical swab, male urethral swab and urine specimen clinical studies, performance characteristics for detecting CT and GC are derived from high prevalence populations. Positive results in low prevalence populations should be interpreted carefully with the understanding that the likelihood of a false positive may be higher than a true positive.
7. The APTIMA Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For those patients for whom a false positive result may have adverse psycho-social impact, the CDC recommends retesting.
8.  Performance of endocervical, vaginal and male urethral swab specimens; male and female urine and PreservCyt solution liquid Pap specimens have not been evaluated in adolescents < 14 years of age.