GeneProof HIV type 1 (HIV-1) PCR Kit

 

CE1023 IVD 

PRODUCT ADVANTAGES

HIGH DIAGNOSTIC SPECIFICITY AND SENSITIVITY

  • Diagnostic sensitivity was verified on 128 HIV positive plasma samples acquired from Centre for AIDS Reagents (CFAR), National Institute for Biological Standards and Control (NIBSC)
  • Diagnostic specificity was verified on 500 HIV negative samples

DUAL TARGET DETECTION

  • Dual targeting prevents detection failure caused by possible mutations inside the HIV-1 genome

DETECTS A BROAD SPECTRUM OF HIV-1 SUBTYPES

  • HIV genotypes A - D, AE, F, AG-GH, Group N, Group O, BF, H, K, CRF03_AB

SINGLE TUBE READY-TO-USE MASTERMIX

  • Contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary
  • Reduces the need for qualified laboratory staff
  • Ensures reproducibility of the result

CONTROL OF THE WHOLE DIAGNOSTIC PROCESS

  • RNA extraction, reverse transcription and PCR amplification

 

 TECHNICAL SPECIFICATION

Technology real-time PCR
Type of analysis qualitative and quantitative
Target Sequence LTR sequence and GaG gene
Analytical Specificity HIV genotypes A - D, AE, F, AG-GH, Group N, Group O, BF, H, K, CRF03_AB, 100%
Analytical Sensitivity (LoD) reaches up to 273.971 IU/ml i.e. 153.424 cp/ml with the probability of 95 % (on HIV-1 NIBSC 16/194 using manual extraction GeneProof PathogenFree RNA Isolation Kit)
reaches up to 548.121 IU/ml i.e. 306.948 cp/ml with the probability of 95 % (on HIV-1 NIBSC 16/194 using automatic extractor croBEE NA16 Nucleic Acid Extraction System)
reaches up to 98.59 IU/ml i.e. 55.21 cp/ml with the probability of 95 % (on Acrometrix HIV-1 Panel IU/ml using manual extraction SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution)
Diagnostic Specificity 100 % (CI95 % : 99.10 % - 100 %)
Diagnostic Sensitivity 93.66 % (CI95 % : 87.96 % - 96.88 %)
Linear Range 109– 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree RNA Isolation Kit)
109– 103 IU/ml with precision of ± 0.5 log (using automatic extractor croBEE NA16 Nucleic Acid Extraction System)
Dynamic Range 109 – 273.971 IU/ml (using manual extraction GeneProof PathogenFree RNA Isolation Kit)
109 – 548.121 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System)
Reporting Units IU/µl
Conversion Factor 1 IU = 0.56 cp
Metrological Traceability HIV NIBSC 16/194
Extraction/Inhibition Control PCR inhibition and RNA extraction efficiency control (ISEX version)
Validated Specimen plasma
Storage -20 ± 5 °C
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation Kit
Instruments croBEE Real-Time PCR System*
Applied Biosystems 7300 / 7500 Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
LightCycler® 480
LineGene 9600 Plus
Mic qPCR Cycler
QuantStudioTM 3/5 Real-Time PCR System
SLAN® Real-Time PCR System
Required Detection Channels FAM, HEX
External Quality Assessment Regularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com
Regulatory Status CE1023 IVD

* Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof HIV type 1 (HIV-1) PCR Kit HIV1/ISEX/025 One-Step RT real-time PCR 25 reactions
GeneProof HIV type 1 (HIV-1) PCR Kit HIV1/ISEX/050 One-Step RT real-time PCR 50 reactions
GeneProof HIV type 1 (HIV-1) PCR Kit HIV1/ISEX/100 One-Step RT real-time PCR 100 reactions