High-Risk HPV with Genotyping
Chlamydia and Gonorrhea (CT/NG)
Mycoplasma genitalium (Mgen)
Trichomonas vaginalis (Trich)
This FDA-approved test and self-collection device offers key advantages for both healthcare providers and patients. By enabling test results to be available before a patient’s visit, self-collection helps streamline workflow and allows for more efficient, informed care decisions. Patients benefit from greater flexibility and convenience, with the option to self-collect in-office or at any of Labcorp’s 2,200+ patient service centers (PSCs) nationwide, providing a comfortable and accessible testing experience.
A comfortable option for patients who avoid testing due to stigma, trauma or discomfort with pelvic exams.
Patients can self-collect in-office or at a Labcorp PSC, eliminating the need for provider-collected samples.
Reduces in-office procedure time while ensuring accurate and timely diagnostics.
Patients who may benefit from self-collection include those who:
Missed routine STI or cervical cancer screenings
Require STI follow-up testing after treatment
Have a history of trauma, discomfort or stigma with pelvic exams
Struggle with transportation, scheduling, or clinic access
Self-collected vaginal swabs have been clinically validated as a reliable alternative to clinician-collected samples, offering comparable sensitivity and specificity.
Self-collected vaginal sample | Clinicial-collected cervical sample | ||||
| HPV 16/18 Positive | 12 other HPV HR Positive | Negative | Total | ||
| HPV 16/18 Positive | 7 | 2 | 3 | 12 | |
| 12 other HPV HR Positive | 0 | 82 | 32 | 114 | |
| Negative | 1 | 16 | 345 | 362 | |
| Total | 8 | 100 | 380 | 488 | |
| Result % | 95% confidence interval | |
| HPV 16/18 Positive | Positive percent agreement | 87.5% | 52.9%-97.8% |
| 12 other HPV HR Positive | Positive percent agreement | 82% | 73.3%-88.3% |
| 14 HPV HR | Positive percent agreement | 84.3% | 76.2%-89.9% |
| Negative percent agreement | 90.8% | 87.5%-93.3% |
Agreements between Self-Collected Vaginal Specimens using FLOQSwabs® 552C.RM and Clinician-Collected Cervical Specimens1
STI | Sensitivity | Specificity |
|
Chlamydia trachomatis (CT) | 97.2% | 94.9% |
|
Neisseria gonorrhoeae (NG) | 97.3% | 99.2% |
|
Mycoplasma genitalium (Mgen) | 98.9% | 98.5% |
|
Trichomonas vaginalis (Trich) | 98.8% | 99.4% |
|
These findings confirm that self-collection offers diagnostic accuracy comparable to clinician-collected specimens, supporting expanded access to STI screening while maintaining high sensitivity and specificity.
Patients may be good candidates if they:
Have skipped recommended STI or cervical cancer screening
Have a history of trauma or anxiety around exams
Lack transportation or availability for in-office testing
Cannot provide a cervical sample from a Pap smear
| Test number | Test name | Container |
|---|---|---|
| 507401 | Self-collection in Office or Patient Service Center, High Risk Human Papillomavirus (HPV) With Genotyping, Vaginal Swab | Copan FLOQSwabs and ThinPrep® vial (Kit PS#144747) |
| 188013 | Self-collection in Office or Patient Service Center, Chlamydia/Gonococcus, NAA, Swab | Aptima® Multitest Swab Specimen Collection Kit (Kit PS#119391) |
| 180105 | Self-collection in Office or Patient Service Center, Mycoplasma genitalium, NAA, Swab | Aptima® Multitest Swab Specimen Collection Kit (Kit PS#119391) |
| 188024 | Self-collection in Office or Patient Service Center, Trichomonas vaginalis, NAA, Swab | Aptima® Multitest Swab Specimen Collection Kit (Kit PS#119391) |
In-office or at any of Labcorp’s 2,200+ PSCs nationwide
Available in 3-4 days via Labcorp Link or EMR integration
Patients may access their results via Patient Portal
For positive results, providers can determine next steps using evidence-based guidelines.
1. Cobas® HPV test. Package inserts Roche; 2024.
2. Mycoplasma genitalium assay. Package insert. Aptima®; 2019.
3. Neisseria gonorrhoeae assay. Package insert. Aptima®; 2021.
4. Chlamydia trachomatis assay. Package insert. Aptima®; 2021.
5. Trichomonas vaginalis assay. Package insert. Aptima®; 2023.
