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GeneProof HIV type 1 (HIV-1) PCR Kit

CE 1023 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 MASTER MIX

  • 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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof HIV type 1 (HIV-1) PCR Kit HIV/ISEX/025 real-time PCR 25 reactions
GeneProof HIV type 1 (HIV-1) PCR Kit HIV/ISEX/050 real-time PCR 50 reactions
GeneProof HIV type 1 (HIV-1) PCR Kit HIV/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_HIV1_QCMD_C1.2019_EN
pdf, [206.13 kB]
GP_Instand_03.2019_EN
pdf, [303.02 kB]
Choose all

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 Method 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
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System

Required Detection Channels FAM, HEX
Quality Control Quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panelsresults at www.geneproof.com
Certification CE1023 IVD for in vitro Diagnostics Use 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.45 MB]
GP_HIV1_Instruction for Use_EN
pdf, [105.06 kB]

Declaration of Conformity

GP_FQAS EC Certificate_EN
pdf, [48.26 kB]
GP_HIV1_Declaration of Conformity_EN
pdf, [345.5 kB]
GP_HIV1_EC Design Examination Certificate_EN
pdf, [39.07 kB]

MSDS

GP_HIV1_Safety Data Sheet_EN
pdf, [256.49 kB]

Manual

Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_EN
pdf, [1.53 MB]

Product Leaflet

GP_HIV1_Leaflet_EN
pdf, [154 kB]

PCR Template

GP_HIV-1_Mic_1
micassay, [14.73 kB]
Files are available only for registered users.

Order

+420 543 211 679
sales@geneproof.com


Technical Support 

Send request
+420 730 176 222
support@geneproof.com


FAQ


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