How is the sample for the Anyplex II (Human Papillomavirus) HPV28 Detection test performed?

From the Guidelines

The Anyplex II HPV28 Detection test is performed using a cervical or vaginal sample collected by a healthcare provider, typically obtained during a pelvic examination using a cervical brush or spatula, and placed in a liquid-based cytology medium or specific transport medium to preserve the cells and viral DNA. The sample collection method is similar to that used for a Pap smear, though the processing differs as the Anyplex II test specifically analyzes for the presence of HPV DNA using real-time PCR technology 1. The test can detect and differentiate between 28 HPV genotypes, including high-risk types associated with cervical cancer.

Some key points to consider when performing the sample collection for the Anyplex II HPV28 Detection test include:

• The sample is typically obtained during a pelvic examination using a cervical brush or spatula, which is inserted into the vaginal canal to collect cells from the cervical transformation zone.
• For women who have had a hysterectomy, vaginal samples may be collected instead.
• The collection device is then placed in a liquid-based cytology medium or specific transport medium to preserve the cells and viral DNA.
• Proper sample collection is crucial for accurate results, as inadequate cellular material may lead to false-negative results.
• Patients should avoid using vaginal medications, douches, or having sexual intercourse for 48 hours before the test to ensure optimal sample quality, as recommended by guidelines for HPV testing 1.

It is essential to follow the recommended sample collection and handling procedures to ensure accurate results and minimize the risk of false negatives or false positives. The Anyplex II HPV28 Detection test is a valuable tool for cervical cancer screening, and proper sample collection is critical to its effectiveness 1.

From the Research

Sample Collection and Preparation

• The Anyplex II HPV28 Detection test requires a cervical sample, which can be collected using a cervical swab or liquid-based cytology [(2,3,4,5,6)].
• The sample is then prepared for testing, which may involve processing the cervical swab or liquid-based cytology sample to extract the DNA [(2,3,4,5,6)].

Test Procedure

• The Anyplex II HPV28 Detection test uses real-time PCR to detect 28 HPV types, including 19 high-risk and 9 low-risk types [(2,3,4,5,6)].
• The test involves amplifying the HPV DNA using PCR and then detecting the amplified DNA using a fluorescent probe [(2,3,4,5,6)].
• The results are then analyzed to determine the presence and type of HPV infection [(2,3,4,5,6)].

Comparison with Other Assays

• The Anyplex II HPV28 Detection test has been compared with other commercial assays, such as the Hybrid Capture 2 assay, Cobas 4800 HPV, and Linear Array HPV, and has shown good concordance and sensitivity [(3,4,5)].
• The test has also been compared with the Allplex HPV28 assay, which uses different chemistry and results analysis, and has shown similar results 6.

Clinical Performance

• The Anyplex II HPV28 Detection test has been shown to have good clinical performance, with high sensitivity and specificity for detecting high-risk HPV types [(2,3,4,5)].
• The test has also been shown to be useful for predicting the presence of cervical intraepithelial neoplasia grade 2 or higher (≥CIN2) 3.