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Human Papillomavirus HPV Genotyping Detection Kit (Fluorescence PCR Method)

  • Fluorescent PCR
  • Target: 18 high-risk & 15 lr-risk HPV viruses
  • Premixed Lyphilized regeants
  • For research use only
 
Package Specification:
Availability:
Quantity:
  • PR2026-HP04

  • Bioteke

Human Papillomavirus(HPV) Genotyping Detection Kit

For Research Use Only


Intended Use
The Human Papillomavirus(HPV) Genotyping Detection Kit(Fluorescence PCR Method) is used for in vitro qualitative detection of high-risk and low-risk human papillomavirus(HPV) in human vaginal swabs, cervical exfoliated cells and urine specimens.

  • 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.


Principle
The kit 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 serves as the monitor to confirm successful extraction & identify possible PCR inhibition for the entire testing system to prevent false negative detection results.

  • UDG enzyme/dUTP system was added to the amplification system to effectively degrade the amplified products & avoid false positive results.

  • This kit is a fully premixed lyophilized system. Taq enzyme, UDG enzyme, reaction buffer, specific primers and probes required for amplification are all lyophilized in PCR tubes.



Parameters
  • Model: PR2026-HP04

  • Format: Test cassette

  • Storage: -25~-15℃(-13~5℉)

  • Shelf life: 12 months


Kit Components


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

NOTE:

1. The reagents repeated freezing and thawing should not exceed 7 times.

2. The kit can be transported at room temperature. (No more than 1 month)


Operation Process

hpv pcr test process




PCR Amplification

  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


Performance
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.







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