INTENDED USES AND LIMITATIONS FOR CLINICAL USE AND MANAGEMENT

To view the product insert for all of the test data, click on the title of the test, or refer to the *respective statement.

Only minimal ThinPrep® approved lubricants should be used during collection. The clinician must determine the use and relevance of the results of these tests when ordering outside of these parameters and should be regarded as investigational or for research.

HPV High Risk:

The Aptima HPV assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The Aptima HPV assay does not discriminate between the 14 high-risk types. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the Aptima HPV assay. The assay is used with the Tigris DTS System or the Panther System. The use of the test is indicated: 1. To screen women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy. 2. In women 30 years and older, the Aptima HPV assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

 

This assay is not intended for use as a screening device for women under age 30 with normal cervical cytology. The Aptima HPV assay is not intended to substitute for regular cervical cytology screening. Detection of HPV using the Aptima HPV assay does not differentiate HPV types and cannot evaluate persistence of any one type. The use of this assay has not been evaluated for the management of HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or who have other risk factors (e.g., HIV+, immunocompromised, history of sexually transmitted infection). The Aptima HPV assay is designed to enhance existing methods for the detection of cervical disease and should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.

Aptima HPV 16 18/45 Genotype Assay:

The Aptima HPV 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 45 in cervical specimens from women with Aptima HPV assay positive results. The Aptima HPV 16 18/45 genotype assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the Aptima HPV 16 18/45 genotype assay. The assay is used with the Tigris DTS System or the Panther System. The use of the test is indicated: 1. In women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. 2. In women 30 years and older, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

This test is not intended for use in determining the need for treatment (i.e. excisional or ablative treatment of the cervix) in the absence of high-grade cervical intraepithelial neoplasia (CIN). Women who are HPV 16/18/45 positive should be monitored carefully for the development of high-grade CIN according to current practice guidelines. The Aptima HPV 16 18/45 genotype assay is not intended for use as a stand-alone assay. The assay should be performed only as a follow-up to an Aptima HPV assay positive result, and should be interpreted in conjunction with cervical cytology test results. The Aptima HPV 16 18/45 genotype assay is not intended for use in women under age 30 with normal cervical cytology. The Aptima HPV 16 18/45 genotype assay is not intended to substitute for regular cervical cytology screening. The use of this test has not been evaluated for the management of HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or who have other risk factors (e.g. HIV+, immunocompromised, history of sexually transmitted infection).

Chlamydia and Gonorrhea (Aptima Combo 2 Assay):

A negative infection does not preclude a possible infection because results are dependent on adequate specimen collection.  Test results may be affected by improper specimen collection, technical error or target levels below the assay limit of detection.  Testing performed using Transcription Mediated Amplification.  The effects of tampon use, douching, and specimen collection variables have not been assessed for their impact on the detection of CT or GC.  The Aptima Combo 2 Assay has not been validated for use with vaginal swab specimens collected by patients at home.   On the Panther System, the assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, clinician-collected gynecological specimens collected in the PreservCyt® Solution, patient-collected vaginal swab specimens, and urine specimens. Performance with specimens other than those specified under Specimen Collection and Storage has not been evaluated.  The performance of the Aptima Combo 2 Assay has not been evaluated in adolescents less than 14 years of age.

Aptima Trichomonas Assay:

A negative infection does not preclude a possible infection because results are dependent on adequate specimen collection.  Test results may be affected by improper specimen collection, technical error or target levels below the assay limit of detection.  A negative result does not preclude a possible infection because the presence of Trichomonas tenax or Pentatrichomonas hominis in a specimen may affect the ability to detect T. vaginalis rRNA.  The effects of tampon use, douching, and specimen collection variables have not been assessed for their impact on the detection of Trichomonas vaginalis.  TV-positive mucoid samples may exhibit decreased RLU values. To ensure proper endocervical sampling, excess mucus should be removed.  This assay has not been validated for use with vaginal swab specimens collected by patients.  Performance has not been evaluated in women less than 14 years of age.  If a specimen has a small number of T. vaginalis organisms, uneven distribution of these trichomonads may occur, which may affect the ability to detect T. vaginalis rRNA in the Aptima Trichomonas vaginalis Assay 16 503684 Rev. 002 Limitations Aptima® collected material. If negative results from the specimen do not fit with the clinical impression, a new specimen may be necessary.

Vaginitis and Leukorrhea Panel: See Chlamydia, Gonorrhea and Trichomonas information above.  See the *statement below for Gardnerella and Candida.

Aptima HSV 1 & 2 Assay: 

The Aptima® Herpes Simplex Viruses 1 & 2 assay (Aptima HSV 1 & 2 assay) is an in vitro diagnostic nucleic acid amplification test (NAAT), using real time transcription-mediated amplification (TMA), for the qualitative detection and differentiation of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) messenger RNA (mRNA) in clinician-collected swab specimens from anogenital skin lesions. The assay is intended for use with swab specimens placed in Aptima specimen transport medium (STM) or in viral transport media (VTM) that is immediately diluted into STM. The Aptima HSV 1 & 2 assay is intended for use as an aid in the diagnosis of HSV-1 and/or HSV-2 infections in symptomatic male and female patients. The Aptima HSV 1 & 2 assay is indicated for use on the Panther® system. Warning The Aptima HSV 1 & 2 assay is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening.  The Aptima HSV 1 & 2 assay is not intended for use with cerebrospinal fluid or for prenatal screening.  Reliable results are dependent on adequate specimen collection, transport, storage, and processing.  The Aptima HSV 1 & 2 assay is used with swab specimens collected from male and female anogenital skin lesions and stored in the Aptima specimen transport media (STM) and viral transport media (VTM). Performance characteristics of other specimen types have not been established.  The Aptima HSV 1 & 2 assay has not been validated for use with patient-collected lesion swab specimens.  The Aptima HSV 1 & 2 assay detects and differentiates between HSV-1 and HSV-2 only. It does not detect or differentiate any other Herpes virus types.  The Aptima HSV 1 & 2 assay does not distinguish between infectious and non-infectious HSV-1 and HSV2.  Results from the Aptima HSV 1 & 2 assay should be interpreted in conjunction with other clinical data available to the clinician.  The Aptima HSV 1 & 2 assay provides qualitative results. Therefore, a correlation cannot be drawn between the magnitude of a positive assay signal and the HSV viral load in a specimen.  A negative Aptima HSV 1 & 2 assay result does not preclude a possible infection because results are dependent on adequate specimen collection. The assay results may be affected by improper specimen collection, technical error, clinical stage of the lesion sampled, or target levels below the assay limit of detection.  *ThinPrep testing has been validated at our reference laboratory, but a direct scraping of the lesion is critical for sampling.  

Group B Strep: *

* Method: Real-time PCR.  This test was developed and its performance characteristics determined by ProPath Services, LLC.  It has not been cleared or approved by the U.S. Food and Drug Administration (FDA).  The laboratory is regulated under CLIA as qualified to perform high-complexity testing.  This test is used for clinical purposes.  It should be regarded as investigational or for research.   Performed by reference lab, ProPath,1355 River Bend Drive, Dallas, TX 75247 1-800-258-1253.  For detailed performance characteristics, limitations and collection method please visit www.ProPath.com/test-menu and Obstetrics and Gynecology.