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EC CERTIFICATE

EC Declaration of Conformity Annex (List B)

EC Declaration of Conformity Annex (Others)

CERTIFICATE ISO 13485

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AmpliSens
AmpliSens HPV HCR-genotype-titre-FRT
Cat.: R-V67-F-CE
Name: AmpliSens HPV HCR-genotype-titre-FRT
Number of tests: 110
Detection Method: FRT
Packaging arrangement (PA): Kit with reagents only for amplification step
Content: All reagents are in individual vials (no PCR-tubes) + Taq-F polymerase (hot start)
Type: Non-aliquoted
Shelf life: 12 months

Information bulletin to AmpliSens HPV HCR-genotype-titre-FRT PCR kit (version 10.10.2018, update: 15.10.2018)
AmpliSens HPV HCR genotype-titre-FRT PCR kit Instruction Manual (update 22.07.2021)
Guidelines to AmpliSens HPV HCR-genotype-titre-FRT PCR kit (update 28.07.2021)


AmpliSens HPV HCR genotype-titre-FRT PCR kit is an in vitro nucleic acid amplification test for qualitative and quantitative detection and differentiation of DNA of human papillomaviruses of high carcinogenic risk (HPV HCR) in the biological material (urogenital swabs, biopsy material of cervical mucous membrane) using real-time hybridization-fluorescence detection of amplified products.

AmpliSens HPV HCR genotype-titre-FRT PCR kit is developed for qualitative and quantitative definition of genotypes of HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68.

Recommended extraction kits: DNA-sorb-AM (K1-12-100-CE)and DNA-sorb-C (K1-6-50-CE). It is possible to use other nucleic acid extraction protocols.

Adapted for:

  • Rotor-Gene 3000/6000 (Corbett Research, Australia)
  • Rotor-Gene Q (QIAGEN, Germany)
  • iCycler iQ5 (Bio-Rad, USA)
  • Mx3000P (Stratagene, USA)
  • CFX96 (Bio-Rad, USA)


 
Attention!!! Number of tests includes controls and calibrators (for quantitative tests).

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