STI Testing

STI Testing Panels Offered by Pangea
Laboratory

According to the Centers of Disease Control and Prevention (CDC), 20% of people in the US had a sexually transmitted infection (STI) on any given day in 2018. The incidence of STIs has since risen, due to a vast majority of these infections being asymptomatic and an overall decline in routine STI screenings during the pandemic. When left untreated, STIs can lead to serious health complications, ranging from infertility to a heightened risk of developing certain cancers.

For clinicians who want to offer more comprehensive STI testing options to their patients, Pangea Laboratory offers several multiplex tests to simultaneously detect common STIs:

Abbott’s FDA-approved Alinity™ m STI Assay, a 4-in-1 multiplex polymerase chain reaction-based test that can identify up to four common STI pathogens: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG)

PrecisionBIOME®, a proprietary Research Use Only (RUO) test that offers comprehensive identification of key bacterial, fungal, and viral species that could be driving an infection.

Upon receipt of a sample, Pangea can turn around an Alinity™ m STI test within 24 hours and a PrecisionBIOME® test within 48 to 72 hours, so physicians can deliver timely care to patients with acute or chronic infections. Urgent care centers, primary care physicians and OB-GYNs can improve their ability to care for their patients with efficient, effective, and comprehensive STI testing services from Pangea Laboratory. Contact our team today to learn more.

Alinity™ m STI Assay

4-Plex Test
PCR-Based Test
FDA Approved
24-Hour Turnaround

The Alinity™ m STI Assay requires just one vaginal swab for female patients or a urine sample for male patients collected in a healthcare setting to test for four common STI pathogens: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG). As the only FDA-approved STI multiplex test run on advanced molecular technology, this first-of-its-kind test can help physicians diagnose infections correctly and efficiently.

Alinity™ m – Abbott’s most advanced high-volume laboratory molecular instrument – utilizes PCR technology, which works by amplifying DNA fragments to detect DNA and RNA fragments in a sample. This quick, specific, and highly sensitive method results in greater accuracy when it comes to diagnosing certain infectious diseases in both symptomatic and asymptomatic individuals. The test qualitatively detects and differentiates between:

green-dot   Ribosomal RNA from Chlamydia trachomatis (CT)
green-dot   DNA from Neisseria gonorrhoeae (NG)

green-dot   Ribosomal RNA from Trichomonas vaginalis (TV)
green-dot   Ribosomal RNA from Mycoplasma genitalium (MG)

Specific diagnosis of STI pathogens can enhance both treatment compliance and partner notification. This is why the FDA strongly recommends the use of nucleic acid amplification tests (NAAT), like PCR, which have the sensitivity and specificity to detect small concentrations of a virus that traditional methods like wet mount or culture testing may miss. For example, certain pathogens like Mycoplasma genitalium have complex and highly particular growth requirements, only growing when specific nutrients are included in the culture medium.

The level of detection (LoD) claim for the Alinity™ m STI Assay is as follows for each of the organisms in urogenital specimen types:

green-dot   CT: 17.0 Elementary Bodies (EB)/mL
green-dot   NG: 7.5 Colony Forming Units (CFU)/mL

green-dot   TV: 0.1 TV/mL
green-dot   MG: 165 Genome Equivalents (GE)/mL

Why Comprehensive Testing for Key STI Pathogens Matters

Sexually transmitted infections are frequently asymptomatic. Without testing, individuals may not receive necessary treatment, and unknowingly become a carrier of these pathogens and spread them to others. Consistent screening of sexually active individuals and providing treatment where needed is the best way to prevent this. If left untreated, both symptomatic and asymptomatic STIs can result in severe health issues in the long term, from infertility to cancer, making diagnosis and treatment critical before the infection leads to life-threatening complications. With the Alinity™ m STI Assay, clinicians can test for four common STIs at once, making the experience more convenient for their patients.

Chlamydia trachomatis (CT)

Symptoms of CT infection include abnormal vaginal discharge, painful sexual intercourse, bleeding after sex and between periods, discharge from the penis, and testicular pain or swelling. A burning sensation during urination could also be a sign of an infection. When left untreated, even asymptomatic infections can ascend through the uterus to the ovaries causing salpingitis, pelvic inflammatory disease (PID), ectopic pregnancies, and tubal factor infertility. Children born to infected mothers can potentially contract inclusion conjunctivitis, nasopharyngeal infections, and pneumonia due to CT. Untreated men may develop complications including epididymitis. CT can also infect the oropharynx and rectum in both men and women.

Neisseria gonorrhoeae (NG)

NG is one of the most common STIs, with an estimated 1.5 million new infections occurring every year. Symptomatic NG infections can cause painful urination, abnormal discharge, and unusual sores or rashes in both men and women. Rectal infection can result in symptoms ranging from itching to bleeding and painful bowel movements, while oropharyngeal infection can show up as a sore throat. NG is most frequently asymptomatic in women, and without treatment, complications like acute salpingitis or PID can occur, which are both linked to infertility.

Trichomonas vaginalis (TV)

TV is one of the most commonly occurring STIs in the US, with more than 2 million infections reported to the CDC annually. Infections in women can cause vaginitis, urethritis, and cervicitis, leaving them more susceptible to the infection and transmission of the human immunodeficiency virus (HIV). When left untreated, adverse outcomes associated with TV include infertility, PID, premature rupture of membranes, and adverse birth outcomes like preterm delivery and low birth weight. TV in men can lead to non-gonococcal urethritis (NGU), epididymitis, or prostatitis. 70-85% of patients infected with TV are asymptomatic, so regular testing of sexually active individuals is instrumental to their health.

Mycoplasma genitalium (MG)

MG infections are often difficult to identify as they are largely asymptomatic, or result in symptoms that are common to other STIs leading to misdiagnoses. Traditional methods of STI detection like cell culture also have a high false negative rate when it comes to identifying MG. Additionally, treatments that typically work for other STIs tend to have lower efficacy in treating MG. MG causes 20-25% of non-chlamydial NGU in men and has been detected in up to 30% of cervicitis cases in women. There are also associations between MG infection and infertility, PID, and preterm birth.

Collection Instructions for the Alinity™ m STI Assay

Sample collection for the Alinity™ m STI Test is easy when following the instructions laid out in the Alinity™ m multi-Collect Specimen Collection Kit:

green-dot   Only Abbott’s multi-Collect Specimen Collection Kit can be used to collect samples for the Alinity™ m STI test, as other transport media are not compatible.

green-dot   For swab specimen collections, only the orange shaft swab provided in the Alinity™ m multi-Collect Specimen Collection Kit should be used, and each transport tube should only contain a single swab.

green-dot   For urine specimen collections, ensure that the urine level falls within the clear fill window of the Specimen Transport Tube label.

green-dot   Specimens can be shipped at room temperature within 14 days of sample collection.

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Potential Limitations of the Alinity™ m STI Assay

As with any diagnostic test, results from the Alinity™ m STI Assay should be interpreted in conjunction with other clinical and laboratory findings. The Alinity™ m STI Assay is not intended to replace other methods such as cervical exams for the diagnosis of urogenital infection. Patients may have cervicitis, urethritis, urinary tract infections, or vaginal infections due to other causes or concurrent infections with other agents.

Reliable results are dependent on appropriate specimen collection and handling. The test has also not been evaluated for patients under 14.

A negative test result does not preclude the possibility of infection and can be caused by improper specimen collection, technical error, specimen mix-up, or target levels below the assay limit of detection (LoD). Please note that the test has yet to be validated for use with vaginal swab specimens collected by patients at home. Though rare, mutations within the highly-conserved regions covered by the primers and/or probes of the Alinity m STI Assay may result in failure to detect the presence of the organism(s).

Note that the Alinity™ m STI Assay should not be used to determine the success or failure of therapeutic interventions, as nucleic acids may persist even after appropriate antimicrobial therapy.

For all limitations, please contact the Pangea Laboratory team.

PrecisionBIOME® Women’s Health

Comprehensive
Multiplex Test
NGS-Based
Test
Offer Antibiotic
Resistance Data
48 to 72-Hour
Turnaround

PrecisionBIOME® Women’s Health is a molecular diagnostic test that uses Next-generation DNA sequencing (NGS) technology to detect and identify microorganisms and viruses in vaginal infections. Using the power of NGS, PrecisionBIOME® Women’s Health offers the most comprehensive approach for the diagnosis of vaginal infections available. In one single test, PrecisionBIOME® targets and sequences DNA from bacterial and fungal pathogens in a sample, along with specific viruses, parasites, and antimicrobial resistance to commonly prescribed antibiotics. This way, PrecisionBIOME® eliminates the need for separate tests.

PrecisionBIOME® can also be used to identify asymptomatic or difficult-to-diagnose infections that could otherwise go undetected in generalized PCR panels or more traditional methods of testing for STIs and other genital tract infections. Since asymptomatic bacterial vaginosis and intermediate flora are risk factors for adverse pregnancy outcomes, adequate and timely treatment can have a positive impact on women who are trying to conceive.

The emergence of antibiotic drug resistance has become a major global public health concern, with multidrug resistance detected in sexually transmitted pathogens, particularly Neisseria gonorrhoeae (NG). NG has developed resistance to almost every antibiotic used to treat it. Rapid drug resistance has also emerged in Mycoplasma and Ureaplasma species, with Mycoplasma genitalium (MG) showing high levels of resistance to first- and second-line treatments.

Prevention and detection are critical to controlling the continued spread of antibiotic-resistant infections. PrecisionBIOME® Women’s Health helps by providing crucial information on pathogen-specific antibiotic resistance.

Contact Us Today to Learn More About Our Testing Options

Replace Separate Vaginal Tract Tests with One Comprehensive Test

PrecisionBIOME® Women’s Health offers a more comprehensive and precise solution, providing the following information in one clear report:

green-dot   Lists of pathogens detected in the sample
green-dot   Comprehensive profiles of bacteria and fungi detected in the sample
green-dot   Relative abundance of each bacterium and fungi detected
green-dot   Pathogen-specific antibiotic resistance to commonly prescribed antibiotics to combat antibiotic-resistant infections

PrecisionBIOME® can be used to detect the relative abundance of causative agents of various sexually transmitted infections like Bacterial Vaginosis and Aerobic Vaginitis, including:

green-dot   Neisseria gonorrhoeae
green-dot   Chlamydia trachomatis
green-dot   Mycoplasma genitalium
green-dot   Trichomonas vaginalis
green-dot   Herpes simplex viruses 1 and 2
green-dot   Human papillomavirus (HPV) (All HPV Genotypes)
subBullet   High-risk HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59
subBullet   Low-risk HPV 6, 11, 42, 43, and 44
green-dot   Mycoplasma hominis
green-dot   Ureaplasma parvum
green-dot   Ureaplasma urealyticum
green-dot   Candida vulvovaginitis

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