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STI Panel PCR (Includes CT/NG/TV/MG)

CT, NG, TV, Trich, MG, MGEN, STI, chlamydia, gonorrhea, trichomoniasis, mycoplasma

Test Codes

EPIC: LAB1230890, Beaker: STI PANEL

Department

Molecular Pathology

Instructions

Nucleic acid amplification testing (NAAT) is the preferred option for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG).  Swabs (vaginal or endocervical) in Alinity m Multi-collect media and urine in Alinity m Multi-collect media are acceptable for testing. 

Specimen Collection Criteria

Collect: Swabs or urine as described below:

SWABS: Vaginal (patient-collected or clinician-collected), Endocervical

• Note: Patient-collected vaginal samples must be collected in a healthcare setting
• Collect swab in Alinity m Multi-collect media

URINE (Male or Female):  

Preferred specimen: First void urine in Alinity m Multi-collect media. To ensure specimen integrity, collecting locations should refrain from sending urine in sterile collection cups and should instead transfer urine into Alinity m Multi-Collect Media prior to transport.

Also acceptable:

• First void clean catch urine in a sterile collection container or yellow top urine tube. (Minimum: 5.0 mL)
• Midstream urine in a sterile container or yellow top urine tube. Midstream specimens have decreased clinical sensitivity and are of limited diagnostic value. (Minimum: 5.0 mL)

Urine Collection Instructions:

1. First void ("dirty") urine is included in this collection, this is collected before a UA specimen, if both are needed.
2. Do not cleanse the genital area prior to specimen collection.
3. Patient should not have urinated for at least one hour prior to sample collection.
4. Follow directions above to obtain a first void urine specimen.
5. Discard specimen collection swab, it is not required for urine specimen collection.
6. Unscrew the transport tube cap, taking care not to spill the transport buffer within.
7. Handle the cap and tube carefully to avoid contamination.
8. Use the plastic transfer pipette to transfer urine from the collection cup into the transport tube until the liquid level in the tube falls within the clear fill window of the transport tube label or else a new specimen should be collected.
9. Do not overfill. Slightly more than one full squeeze of the transfer pipette bulb may be required to transfer the necessary volume of urine specimen.
10. Recap the transport tube carefully. Ensure the cap seals tightly.
11. Label the transport tube with sample identification information, including date of collection. Take care not to obscure the fill window on the transport tube.

STI Panel PCR MUST be ordered at the time of collection.

Add-on tests CANNOT be performed on urine specimens following testing on other Instrumentation (i.e., urinalysis).

Physician Office/Draw Specimen Preparation

• Swabs and urine collected in Alinity m Multi-collect media can be stored and transported at room temperature (20-26°C or 68-78.8°F) or refrigerated (2 to 8°C or 36 to 46°F).
• If unpreserved urine is sent, samples must be refrigerated (2 to 8°C or 36 to 46°F) and must be transported to Alinity m Multi-Collect Media within 24 hours of collection. Samples beyond this stability will be rejected. To avoid this, it is recommended that the collecting location transfer urine from the sterile cup to the Alinity m Multi-Collect Media prior to transport.

Preparation for Courier Transport

Transport: Swabs and urine collected in Alinity m Multi-Collect Media can be stored and transported at room temperature (20 to 26°C or 68 to 78.8°F) or refrigerated  (2 to 8°C or 36 to 46°F). Unpreserved/neat urine samples must be refrigerated (2 to 8°C or 36 to 46°F) and transported to Alinity m Multi-Collect Media within 24 hours of collection. Samples beyond this will be rejected. 

Rejection Criteria

• Unlabeled specimens.
• Specimens submitted in transport media other than Alinity m multi-collect specimen collection media.
• Urine specimens sent in a sterile container that were not refrigerated or have not been transferred to Alinity m Multi-Collect Media within 24 hours of collection.
• SurePath or ThinPrep liquid-based cytology specimens.
• Add-on requests for samples that have been previously run on other instrumentation.
• Requests for testing on patients <14 years old. Refer to Send Outs LAB1231880- Chlamydia/Gonorrhoeae DNA w/Confirmation (<14 years) and LAB1231879- Trichomonas  vaginalis DNA (<14 years)).

Inpatient Specimen Preparation

Specimens should be sent to the main Laboratory if received at Royal Oak. Specimens received at other campuses must be added to a packing list before being sent to Royal Oak Laboratory. 

Storage

Abbott Alinity m Multi-collect specimens- Urines, swabs (Vaginal or Endocervical
Room Temperature (20-26°C or 68-78.8°F): 14 days
Refrigerated (2-8°C or 36-46°F): 14 days
Frozen (-20°C/-4°F or below): 60 days

Unpreserved / Neat Urine Specimens
Room Temperature (20-26°C or 68-78.8°F): 24 hours
Refrigerated (2-8°C or 36-46°F): 24 hours
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Alinity m Multi-collect urines and swabs: Room Temperature (20-26°C or 68-78.8°F) for 7 days

Unpreserved / Neat Urine Specimens: Refrigerated (2-8°C or 36-46°F) for 7 days

Laboratory

Royal Oak Molecular Pathology Laboratory

Performed

Monday – Saturday.
Results are usually available within 24-48 hours of receipt in the Laboratory (excluding weekends and holidays).

Reference Range

Chlamydia PCR not detected.
Gonococcus PCR not detected.
Trichomonas PCR not detected.
Mycoplasma genitalium PCR not detected.

Test Methodology

Nucleic acid amplification testing performed using the FDA-cleared Abbott Alinity m STI assay (Abbott Alinity m System).

Interpretation

By report.

Clinical Utility

Infection with Chlamydia trachomatis (CT) is the most frequently reported bacterial sexually transmitted disease (STD) in the United States. CT is the leading bacterial cause of sexually transmitted diseases worldwide, with approximately 89.1 million cases occurring annually. CT is a gram-negative, nonmotile, obligate intracellular bacterium with a unique biphasic lifecycle and is the causative infectious agent for a variety of diseases. CT can cause urethritis, cervicitis, proctitis, conjunctivitis, endometritis, and salpingitis; if left untreated, the infection may ascend to the uterus, fallopian tubes, and ovaries causing pelvic inflammatory syndrome, ectopic pregnancy, and tubal factor infertility. Reiter’s syndrome (urethritis, conjunctivitis, arthritis, and mucocutaneous lesions) has also been associated with genital CT infection.  Many infections remain asymptomatic, and high numbers of infected patients may not seek care. Patients often become re-infected if their sexual partners are not treated.  Infants born to infected mothers can develop conjunctivitis, pharyngitis, and pneumonia. The predominant symptoms in men and women are increased discharge and dysuria; women may also present with irregular uterine bleeding.

 Neisseria gonorrhoeae (NG) is the causative agent of gonorrhea. NG are gram-negative diplococci, cytochrome oxidase positive, non-motile and non-spore forming. A total of 321,849 cases of NG infection have been reported to the CDC in 2013, corresponding to a rate of 104.2 cases per 100,000 population. Clinical manifestations of NG infections are numerous. In men, acute urethritis presents itself after a 1-to-10-day incubation period with urethral discharge and dysuria. Only a small proportion of men remain asymptomatic without signs of urethritis. Acute epididymitis is the most common complication, especially in young men. In women, the primary site of infection is the endocervix. There is a high prevalence of coalescence of symptoms with C. trachomatis, Trichomonas vaginalis, and vaginosis; many women remain asymptomatic and therefore do not seek medical care. In symptomatic women increased discharge, dysuria, and intermenstrual bleeding may be observed. Pelvic inflammatory disease can occur in 10%-20% of women, combined with endometritis, salpingitis, tubo ovarian abscess, pelvic peritonitis, and perihepatitis. Other gonococcal infected sites in men and women are the rectum, pharynx, conjunctiva, and to a lesser degree the disease presents itself as disseminated gonococcal infection. Infants from infected mothers can develop conjunctivitis.

Trichomonas vaginalis (TV) is the most prevalent non-viral STI in the United States. A population-based study demonstrated an overall prevalence of 3.1% among women aged 14 to 49 years, with rates as high as 13.3% among black women in the general population. Another study found TV prevalence of 11.9% in women aged 36 to 45 years, 7.7% in women aged 51 to 60 years, and 4.2% in women aged 16 to 25 years. Molecular based tests for the detection of TV have shown a detection rate between 7% and 13% among females. However, TV is currently not a reportable disease, and the true estimation of disease prevalence is not currently known. Some of the factors contributing to this are the lack of routine testing, low sensitivity of the traditional laboratory tests, and non-specific symptomatology.

Mycoplasma genitalium (MG) is a fastidious bacterium first isolated in 1980 from the urethral swabs of two symptomatic men with non-gonococcal urethritis (NGU). Infections caused by this bacterium have been associated with male and female urethritis, balanoposthitis, prostatitis, cervicitis, pelvic inflammatory disease, and female infertility. Additional complications, such as preterm delivery and extra-genital infections, have been reported. There have been few studies showing an accurate prevalence of MG, because historically this bacterium is difficult to culture. However, several molecular assays have been described that show a prevalence as high as 47.5%. More recent studies using nucleic acid testing showed an MG prevalence of 16-17% in females, with a higher rate of detection observed in vaginal swabs. Another study showed that 8.1% of males who presented to a public sexual health clinic had MG detected in their urine.

Men with recurrent NGU should be tested for M. genitalium using an FDA-cleared NAAT. Women with recurrent cervicitis should be tested for M. genitalium, and testing should be considered among women with PID. Screening of asymptomatic M. genitalium infection among women and men or extragenital testing for M. genitalium is not recommended. In clinical practice, if testing is unavailable, M. genitalium should be suspected in cases of persistent or recurrent urethritis or cervicitis and considered for PID.

Reference

1. Package insert, Alinity m STI AMP Kit. Revised August 2023: Abbott Molecular, Inc. Ref 09N17-095. 53-608012/R3

CPT Codes

0402U

Contacts

Last Updated

3/17/2025