Specimen Collection Manual and Test Catalog

Self-collected vaginal swab: simpli-COLLECT HPV collection kit. No other collection devices are acceptable.

Specimens must be collected in a clinic setting. Laboratory site and home collections are not permitted.

HPV primary screening by self-collection is recommended for Average-Risk individuals who fulfill all five criteria. For more information, view the Value-based Care Guide for Cervical Cancer Screening in EPIC or refer to the current ASCCP guidlelines.
1. Has a cervix.
2. Age is 30-65 years.
3. Due for cervical cancer screening.
4. Asymptomatic.
     * No abnormal bleeding.
     * No other symptoms concerning for cervical cancer.
5. Not immunosuppressed (e.g. biologics, HIV).

Screening History (must meet at least ONE):
1. Prior normal cervical cancer screening results, or
2. No prior cervical cancer screening (first-time screen), or
3. Remote history of abnormal screening results followed up with a history of   
     normal testing that the patient may safely resume routine cervical cancer screening 
     based on follow-up recommendations from the (ASCCP) Risk-Based Management Consensus 
     Guidelines.

Specimen Collection Guide 

Room temperature (15-30°C) or Refrigerator temperature (2-8°C).

Specimen is stable for 8 days at room temperature (15-30°C) or 14 days at refrigerator temperature (2-8°C).

Specimens store or transported frozen. Stability limits exceeded, improper collection tube/swab used, improperly labeled, mis-identified specimens. Patients that are not in the acceptable date range of 30 to 65 years of age.

Negative for High-Risk Human Papilloma Virus.

This test is a qualitative in vitro assay for the detection of Human Papillomavirus DNA. This assay identifies High-Risk HPV Types 16, 18, 45 while reporting the concurrent detection of the other high risk genotype grouping (31/33/52/58) and 35/39/51/56/66/68).

HPV, Human Papilloma Virus, Primary Screen, Self-collect, Cervical cancer.

Human Papillomavirus (HPV) is a small, non-enveloped, double-stranded DNA virus (approximately 8,000 base pairs) that replicates in the nucleus of squamous epithelial cells and induces hyperproliferative lesions. HPV infections are among the most common sexually transmitted infections. Most HPV infections have a benign clinical consequence and are cleared spontaneously. However, persistent HPV infection in women’s cervix may result in progression to cervical cancer. More than two-hundred different HPV genotypes have been identified, among which over forty infect mucosal and genital epithelia. Genital HPV genotypes are generally classified into high risk (HR) and low risk (LR) groups based on their carcinogenic potential. HR HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) are associated with invasive cervical cancer (squamous cell carcinoma or adenocarcinoma) or its immediate precursor high-grade squamous intraepithelial lesion (HSIL), cervical intraepithelial neoplasia, carcinoma in situ, or adenocarcinoma in situ), whereas LR HPV genotypes induce benign lesions and are not associated with cervical cancer. Three of the 14 HR HPV genotypes, 16, 18, and 45, are associated with approximately 70-80% of invasive cervical cancer cases worldwide.