ALINITY M STI AMP KIT (09N17-095)

Intended Use

The Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG),  ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal   RNA from Mycoplasma genitalium (MG), to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for the following analytes:

CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, male urine, oropharyngeal swabs, and rectal swabs

NG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, male urine, oropharyngeal swabs, and rectal swabs

TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine

MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine

A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.

Limitations of the procedure

FOR IN VITRO DIAGNOSTIC USE. RX ONLY.

1. For females, a vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.
2. False negative results for Neisseria gonorrhoeae were observed from endocervical samples in the clinical study when multiple endocervical samples were collected from one patient. If multiple endocervical samples are necessary from the same patient, and the NG test result is negative, further testing may be indicated if infection with N. gonorrhoeae is strongly suspected.
3. Performance of the assay for the detection of MG has not been established in gynecological specimens in PreservCyt or in female urine.
4. Performance of the assay for the detection of TV and MG has not been established in oropharyngeal or rectal swab specimens.
5. Gynecological specimens in PreservCyt are acceptable for detection of CT, but may detect up to 10.7% fewer CT infections when compared with vaginal swab specimens.
6. First-catch female urine specimens are acceptable for the detection of CT, NG, and TV, but may detect up to 12.3% fewer CT infections, 9.8% fewer NG infections, and 6.6% fewer TV infections when compared with vaginal swab specimens.
7. The Alinity m STI Assay has not been evaluated for patients younger than 14 years of age.
   
8. Assay interference may cause false negative or invalid results. Assay interference may be observed in the presence of seminal fluid at concentrations greater than 3.0% in PreservCyt samples.
9. Cycle number delays were observed for mucus, seminal fluid, γ-globulin, glucose, Preparation H Hemorrhoidal Cream, feces and Sensodyne Repair & Protect Sensitive Toothpaste, which could result in interference at lower target levels (refer to Table 3 and Table 4 in the package insert 53-608012/R2).
10. Performance with specimens collected with other collection media than those specified in the package insert has not been evaluated.
11. Only PreservCyt specimens that have been aliquoted prior to cytology have been evaluated with the Alinity m STI Assay. The use of residual specimens post cytology has not been evaluated.
12. 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).
13. As with any diagnostic test, results from the Alinity m STI Assay should be interpreted in conjunction with other clinical and laboratory findings.
14. Reliable results are dependent on appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the package insert 53-608012/R2).
15. The Alinity m STI Assay has not been validated for use with vaginal swab specimens collected by patients at home. The patient-collected vaginal swab specimen application is limited to health care facilities where support/counseling is available to explain the procedures and precautions.
16. Use of this assay is limited to personnel who have been trained in the procedure. Failure to follow the instructions given in the package insert may result in erroneous results.
17. Nucleic acid contamination from the positive controls or specimens must be monitored by good laboratory practice and careful adherence to the procedures specified in the package insert.
18. A positive result for the presence of CT, NG, TV, and MG nucleic acids does not establish the causative agent for salpingitis or PID. A negative result for CT, NG, TV, and MG nucleic acids does not exclude related infection as a cause of ascending infection.
19. The Alinity m STI Assay has not been evaluated with patients who are currently being treated with antimicrobial agents active against CT, NG, TV, and MG.
20. The Alinity m STI Assay should not be used to determine therapeutic success or failure as nucleic acids may persist after appropriate antimicrobial therapy.
21. The Alinity m STI Assay for male and female urine testing must be performed on first-catch urine specimens (defined as the first 20-30 mL of the urine stream). The effects of other variables such as first-catch vs. mid-stream, post douching, etc. have not been determined.
22. The Alinity m STI Assay is not intended to replace other methods (eg, cervical exam) for 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.
23. Use of the Alinity m STI Assay is not approved for the evaluation of suspected sexual abuse contact tracings as well as for other medico-legal indications.
24. The effects of factors such as vaginal discharge, use of tampons, douching, or other specimen collection variables have not been determined.
25. 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).

ALINITY M MULTI-COLLECT SPECIMEN COLLECTION KIT (09N19-015)

Intended Use

The Alinity m multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female urine specimens, endocervical swab specimens, vaginal swab specimens, oropharyngeal swab specimens, and rectal swab specimens to stabilize nucleic acid for testing with the Alinity m STI Assay. Refer to the Alinity m STI Assay package insert for additional information.

The Alinity m multi-Collect Specimen Collection Kit is not intended for home use.

Limitations of the procedure

FOR IN VITRO DIAGNOSTIC USE. RX ONLY.

• For In Vitro Diagnostic Use Only
• Optimal performance of this kit requires appropriate specimen collection, handling, preparation, and storage (refer to the SPECIMEN COLLECTION PROCEDURES section of the package insert 53-608346/R1).
• This kit should only be used to collect swab samples from the cervix or vagina (females), oropharynx or rectum (males and females), or urine specimens (males and females). Refer to the Alinity m STI Assay package insert for allowable specimen types and any additional information.
• The collection of vaginal samples from pregnant women using the Alinity m multi-Collect Specimen Collection Kit should be conducted by an obstetrical provider or family physician.
• Vaginal swab sampling is not designed to replace cervical exams for diagnosis of female urogenital infections. Patients may have cervicitis, urethritis, urinary tract infections, or vaginal infections due to other causes or concurrent infections with other agents.
• Women who have symptoms suggesting pelvic inflammatory disease (PID) should not use a self-collected vaginal swab specimen as a replacement for a pelvic exam.
• The self-collected vaginal swab specimen application is limited to health care facilities where support and counseling is available to explain the procedures and precautions.