Multiplex Genotype HPV 16 + 18 Real Time Fluorescent PCR Detection Kit (Lyophilized)

Intended use:

Test Principle:

The specific primers and specific fluorescent probes are designed for the conserved region of HPV 16+ 18. The PCR reaction solution, and real-time fluorescent quantitative PCR detection technology is applied on the fluorescence quantitative PCR instrument to realize the rapid detection of HPV 16+ 18 through the change of fluorescence signal. The detection system contains a human internal control (IC) gene, which is used to monitor whether the specimens and the process of the nucleic acid extraction is qualified.

HPV 16 & 18 Genotyping PCR testing solution.pdf

Product components:

Note: Do not mix the components from different batches for detection. The Positive Control of HPV and internal control were constructed artificially, and they were not infectious.

Storage and stability:

1.The kit should be stored under -20±5℃ and protected from light. Its period of validity is 12 months. Products can be shipped at room temperature for 7 days.

2.Repeated thawing and freezing should be no more than 3 times.

Specimen requirements:

1. Specimen type

Cervical shedding cells, vaginal swab, genitourinary tract secretions.

2. Specimen collection and transportation

Clean the sampling site with sterile saline, and then use an epithelial brush (cervical brush, swab, etc.) to collect exfoliated cells from the cervix or genitourinary tract, epithelial cells at the lesion, secretions, etc. swabs, etc.) into a sterile storage tube and seal it for inspection.

3. Specimen preservation

The specimen can be stored for 2 weeks ar 4-8℃ , 3 months at -20± 5℃ and for a long time below -70℃

Interpretation of test results:

NOTE: ‘+ ’ is positive, ‘- ’ is negative.

Operation details please check from IFU