Specifications
Brand Name :
Biokey
Model Number :
BIK-QL-H005S
Certification :
ISO 13485,CE
Place of Origin :
Guangzhou China
MOQ :
We can produce liquid and lyophilized kits
Price :
USD
Payment Terms :
L/C, T/T, Western Union
Supply Ability :
100,000 per day
Delivery Time :
Depending on order quantity
Packaging Details :
Carton package
Package :
48 T/kit(single tube)
Specimen :
Cervical shedding cells, vaginal secretion swab
Applicable :
Micgene 244/244 IVD(BIO-KEY)
Detection limit :
500 copies/mL
CV :
≤5%
Description

Human Papilloma Virus HPV 16 / 18 genotype RT PCR Fluorescence probing PCR test kit


Intended use:

This kit, adopting Real-Time PCR-Fluorescence technology, is used for qualitative detection of HPV 16+ 18. It can be used for the laboratory diagnosis and monitoring of the virus infection. 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-H005S
1 PCR Enzyme Mix (Lyophilized) 48 tests/kit
2 HPV Primer-Probe Mix /
3 Enzyme Mix Buffer (5×) /
4 Positive Control 100 μL/tube
5 Negative Control 100 μL/tube
6 RNase-free water 1mL/tube
7 Paraffin oil 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.

Data anlysis:

The following sample results are possible:

Ct value Result Analysis
1# No Ct Negative
2# ≤38 Positive
3# 38~40 Re-test; if it is still 38~40, report as 2#

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 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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RT HPV PCR Kit 16 18 Genotype Fluorescence Probing Human Papillomavirus Pcr

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Brand Name :
Biokey
Model Number :
BIK-QL-H005S
Certification :
ISO 13485,CE
Place of Origin :
Guangzhou China
MOQ :
We can produce liquid and lyophilized kits
Price :
USD
Contact Supplier
RT HPV PCR Kit 16 18 Genotype Fluorescence Probing Human Papillomavirus Pcr
RT HPV PCR Kit 16 18 Genotype Fluorescence Probing Human Papillomavirus Pcr

Guangzhou BioKey Healthy Technology Co.Ltd

Verified Supplier
3 Years
guangzhou
Since 2003
Business Type :
Manufacturer, Distributor/Wholesaler, Exporter, Seller
Total Annual :
5M-10M
Employee Number :
100~200
Certification Level :
Verified Supplier
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