Guangzhou BioKey Healthy Technology Co.Ltd
                                                                                                           
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23 Years
Since 2003
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Multiplex Hpv Genotype 16 18 Real Time Fluorescent PCR Detection Kit Lyophilized

Price Negotiable
Price: USD
MOQ: We can produce liquid and lyophilized kits
Delivery Time: Depending on order quantity
Brand: Biokey
Product Description

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

 
Intended use:
 

This kit, adopting Real-Time PCR Fluorescence  technology, is used for qualitative detection of HPV 16+ 18 genotyping. It can be used for the medical laboratory diagnosis and monitoring of the virus infection status for learning the prediction of cervical caner. The test results are only for clinical reference, not for case confirmation or exclusion.

 

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.

 


Product components:

 

No. Components BIK-QL-H005 BIK-QL-H005S
1 PCR Enzyme Mix (Lyophilized) 96 tests/bottle 48 tests/kit
2 HPV Primer-Probe Mix 100 μL/vial /
3 Enzyme Mix Buffer (5×) 400 μL/vial /
4 Positive Control 100 μL/tube 100 μL/tube
5 Negative Control 100 μL/tube 100 μL/tube
6 RNase-free water 1mL/tube 1mL/tube
7 Paraffin oil 1.5mL/tube*2 1.5mL/tube

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:

 

  FAM (HPV16) VIC/HEX (HPV18) ROX(IC) Interpretation test results
1 - - - Result invalid, test again
2 + - +/- HPV16(+)
3 - + +/- HPV18(+)
4 + + +/- HPV16 and HPV18(+)
5 - - + Negative(-)

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

 

 Operation details please check from IFU

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Company Guangzhou BioKey Healthy Technology Co.Ltd
Location Add:No.2, Ruitai Rd, Guangzhou Hi-Tech Industrial Development Zone, 510670, CHINA
Contact Person Lisa

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