STI and STD Testing
STI and STD Testing Panels Offered by Pangea
Laboratory
According to the CDC, 1 in 5 people in the US had an STI on any given day in 2018. The incidence of sexually transmitted infections (STIs) has risen since then. This epidemic has been fueled by the precipitous decline of routine STI and sexually transmitted disease (STD) testing in the past few years and the fact that a vast majority of these infections remain asymptomatic. When left untreated, even asymptomatic STIs can lead to serious health complications, from infertility to a heightened risk of developing certain cancers.
Pangea Laboratory offers several multiplex tests to simultaneously detect common STIs and STDs:
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.
The Difference Between STI and STD Testing
Whether a patient is seeking diagnosis and treatment for an STI or an STD, the test performed will be the same. The goal of STI or STD testing is to correctly identify a specific set of pathogens that are most commonly spread through sexual contact, so patients can be treated if necessary.
“STI” and “STD” are often used interchangeably, although there is one key difference according to CDC guidelines, which states that an STD is the “recognizable disease state that developed from an infection”. Because many STIs can take years to display obvious symptoms, or never show symptoms at all, the usage of “STD” can unwittingly cause people to downplay the need to get tested. Many clinicians now prefer to use the term “STI” instead of “STD” for the sake of accuracy and to reduce the stigma around getting tested and treated for these infections.
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 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 clinicians diagnose infections correctly in a more efficient way.
Alinity™ m – Abbott’s most advanced high-volume laboratory molecular instrument – utilizes PCR technology, which works by amplifying DNA fragments to detect targeted DNA or RNA fragments in a sample. This quick, specific, and highly sensitive method results in high accuracy when it comes to diagnosing certain infectious diseases in symptomatic and asymptomatic individuals. The test qualitatively detects and differentiates between:
Ribosomal RNA from Chlamydia trachomatis (CT) DNA from Neisseria gonorrhoeae (NG)
Ribosomal RNA from Trichomonas vaginalis (TV) Ribosomal RNA from Mycoplasma genitalium (MG)
Specific diagnosis of STI pathogens can enhance both treatment compliance and partner notification, which is why the FDA strongly recommends the use of a nucleic acid amplification test (NAAT) like PCR, which has the sensitivity and specificity to detect small concentrations of a virus that other tests, including traditional wet mount or culture testing, might 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 LoD claim for the Alinity m STI Assay is as follows for each of the organisms in urogenital specimen types:
CT: 17.0 Elementary Bodies (EB)/mL NG: 7.5 Colony Forming Units (CFU)/mL
TV: 0.1 TV/mL MG: 165 Genome Equivalents (GE)/mL
Why Comprehensive Testing for Key STI and STD Pathogens Matters
As infection is frequently asymptomatic and can lead to patients being an unknown carrier to spread future infection, consistent screening of sexually active patients is the best way to determine whether patients have contracted an STI and require treatment. In the long term, untreated STIs and STDs can result in severe health issues, from infertility to cancer, making it important to diagnose and treat them before they cause life-threatening complications. With the Alinity™ m STI Assay, clinicians can test for four common STIs together, making it 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 more than 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 the most commonly occurring STI in the US. In women, infections can cause vaginitis, urethritis, and cervicitis, while also leaving them more susceptible to being infected with or transmitting HIV. Left untreated, adverse outcomes associated with TV include PID, infertility, 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.
Mycoplasma genitalium (MG)
MG infections are often difficult to identify as they are largely asymptomatic, result in symptoms that are common in other STIs, and traditional methods of detection like cell culture deliver a high false negative rate. Treatments that typically work for other STIs also tend to have a lower efficacy on 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 is also an association between MG infections and PID, infertility, and pre-term 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:
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.
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.
For urine specimen collections, ensure that the urine level falls within the clear fill window of the Specimen Transport Tube label.
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 be 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® Reproductive Health
Comprehensive
Multiplex Test
NGS-Based
Test
Offer Antibiotic
Resistance Data
48 to 72-Hour
Turnaround
PrecisionBIOME® Reproductive Health is a molecular diagnostic test that uses Next-generation DNA sequencing (NGS) technology for the detection and identification of microorganisms and viruses in urogenital infections. Using the power of NGS, PrecisionBIOME® Reproductive Health offers the most comprehensive approach for the diagnosis of urogenital 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 antibiotic-resistance genes 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 people 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, which 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 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® Reproductive Health helps by providing crucial information on pathogen-specific antibiotic resistance.
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Replace Separate Urogenital Tract Tests with One Comprehensive Test
PrecisionBIOME® Reproductive Health offers a more comprehensive and precise solution, providing the following information in one clear report:
Lists of pathogens detected in the sample Comprehensive profiles of bacteria and fungi detected in the sample Relative abundance of each bacterium and fungi detected 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:
Neisseria gonorrhoeae Chlamydia trachomatis Mycoplasma genitalium Trichomonas vaginalis Herpes simplex viruses 1 and 2 Human papillomavirus (HPV) (All HPV Genotypes)
High-risk HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59
Low-risk HPV 6, 11, 42, 43, and 44 Mycoplasma hominis Ureaplasma parvum Ureaplasma urealyticum Candida vulvovaginitis