HPV Genotype 2+12 High Risk 16+18 Medium Risk PCR Detection Kit 96 Tests/Kit

Intended use:

Principle:

NG product lyophilization pacakage:



Main 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.

Specimen requirements:

1.Specimen type :
Cervical shedding cells, 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 at 4-8℃, 3 months at -20±5℃ and for a long time below -70℃.


Quality control:

Negative Control: None of the FAM, VIC/HEX, ROX& Internal Control (CY5) channels have a Ct value or Ct ＞38;

Positive Control: FAM, VIC/HEX, ROX& Internal Control (CY5) channels Ct ≤ 30;

The above two items should be met simultaneously in one experiment. Otherwise, the experiment is invalid and should be repeated.

Data analysis and interpretation:

The following sample results are possible:

Interpretation of test results:

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

Operation details please check from IFU!

Bio key Health is a high-tech enterprise with integrating R&D, production and sales&marketing in Guangzhou. Since 2003. Bio Key was founded by the "Thousand Talents Program" entrepreneurial team and the overseas senior automation equipment development engineer team.

The company's core team has been in the field of IVD research and entrepreneurship for more than 10 years, and has mastered a wealth of molecular diagnostic POCT industrial application technology, SmartTRF immune detection technology, RT qPCR nucleic acid detection technology and independent research and development capabilities of instruments.

It has a number of independent core technologies in the fields of automation engineering, micro-precision manufacturing, immunofluorescence, nucleic acid detection and gene sequencing. Since its establishment, the company has applied for more than 60 patents and currently has 17 authorized patents. The company has two R&D centers for diagnostic reagents and instruments and equipment, totaling more than 500 square meters; it has established more than 2,000 square meters of GMP workshops and equipment production plants; it has SmartTRF new immune detection technology, nucleic acid detection technology (POCT) and three scientific services.