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Human Papillomavirus HPV Genotyping Detection Kit (Fluorescence PCR Method)

This kit uses highly sensitive fluorescent PCR technology to distinguish and detect a variety of high-risk HPV viruses(18 types) and low-risk HPV viruses(15 types), accurately screen different types of HPV infection, and help medical institutions quickly identify potential virus-infected people for early treatment and intervention.
 
Product form: PCR reagents kit
Specimen: Vaginal swabs, cervical exfoliated cells, urine specimen
Model NO.: PR2026-HP04
Specification: 8 samples/kit; 24 samples/kit
Certificate: CE
 
Package Specification:
Availability:
Quantity:
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  • PR2026-HP04

  • Bioteke


Human Papillomavirus(HPV) Genotyping Detection Kit(Fluorescence PCR Method)

A. Intended Use


  • This kit is used for in vitro qualitative detection of high-risk and low-risk human papillomavirus(HPV).

  • The high-risk HPV includes type 16,18,26,31,33,35,39,45,51,52,53,56,58,59,66,68,73,82; 

  • The low-risk HPV includes type 6,11,40,42,43,44/55,54,57/71,61,70,72,81,84.




B. Principle


  • This reagent is a multiplex fluorescent probe-based Taqman® qPCR assay system.

  • Specific primers and probes are designed for detection of different types of human papillomavirus (HPV).

  • Internal control (IC) is used as a monitoring method to avoid false negative test results.

  • UDG enzyme/dUTP system is added to degrade the amplification product to avoid false positive results.

  • This kit is a fully premixed lyophilized system. Taq enzyme, UDG enzyme, reaction buffer, specific primers and probes have been pre-placed in the reagents.




C. Components


HPV genotyping test kit

Conponents  8 samples/kit
24 samples/kit Ingredient
HP04 Lyophilized Reagent
8×8 strip tubes 24×8 strip tubes

Specific primer&probes for the detection of target pathogens, dNTP/dUTP Mix, Mg2+, Tac polymerase and UDG enzyme

HPV Lysis Buffer
1 mL×1 tube 2.5 mL×1 tube Surface active agent, balanced salt solution
HPV Positive Control
400 mL×1 tube 400 mL×1 tube Plasmid containing every target gene sequence
HPV Negative Control
400 mL×1 tube 400 mL×1 tube Plasmid containing internal control sequence
Dissolving Solution
1 mL×1 tube 1 mL×3 tubes Stabilizer





D. Storage and Shelf Life


Transportation at room temperature below 37℃(<1 month).

Stored at -20℃±5℃ for 1 year.

Repeated freezing and thawing should not exceed 7 times.





E. Overview of the Testing Process


hpv pcr test process




F. PCR Amplification


图片1.


  1. Put the reaction tubes into PCR instrument and set the names of each reaction well in the corresponding order.

  2. Select FAM,VIC/HEX,ROX and CY5 four fluorescence channels for detection.The corresponding targets of each fluorescence channel are shown in the table below:


Location
FAM
VIC/HEX
ROX
CY5
Well 1 HPV type 16
HPV type 18 HPV type 26 Internal Control (IC)
Well 2 HPV type 31 HPV type 33 HPV type 35 HPV type 39
Well 3 HPV type 45 HPV type 51 HPV type 52 HPV type 53
Well 4 HPV type 56 HPV type 58  HPV type 59 HPV type 68
Well 5 HPV type 66 HPV type 73 HPV type 82 HPV type 81
Well 6 HPV type 6 HPV type 11 HPV type 40 HPV type 42
Well 7 HPV type 43 HPV type 44/55 HPV type 54 HPV type 61
Well 8 HPV type 57/71 HPV type 70 HPV type 72 HPV type 84




G. Results Analysis and Interpretation

Please refer to the user manual.




H. Performance Specification

1.Detection limitation: 1000 Copies/mL

2.Precision: The coefficient of variation (CV,%) of Ct value of within-batch/between-batch precision is≤5%.

3.Accuracy: The conformity rate of negative/positive reference:100%.

4.Specificity:The farget organisms had been analyzed in silico for potential cross-reactivity with the primers or probe sequences.

Homology with other species is all below 80%.

Specificity analysis showed that there is no cross reaction with trichomonas vaginalis, neisseria gonorrhoeae, chlamydia trachomatis, gardnerella vaginalis, haemophilus ducreyi, candida albicans, streptococcus agalactiae, ureaplasma urealyticum, ureaplasma parvum, mycoplasma hominis, mycoplasma genitalium, treponema pallidum, herpes simplex virus type 1&2.





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