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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

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

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 HIV1/ISEX/025 real-time PCR 25 reactions
GeneProof HIV type 1 (HIV-1) PCR Kit HIV1/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_HIV_QCMD_08_21_EN_02
pdf, [219.16 kB]
; GP_HIV_QCMD_08_21_EN_01
pdf, [222.53 kB]
; GP_HIV_Instand_03_21_EN
pdf, [1.02 MB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE1023IVD
Intended User For professional use in laboratories with trained staff
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 with 95% probability)

Reaches up to 273.971 IU/ml i.e. 153.424 cp/ml (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 (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 (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/ml

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 201A 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
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panelsresults at www.geneproof.com

 

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_HIV1_Advisory Notice_EN
pdf, [571.83 kB]
; GP_HIV1_Instruction for Use_EN
pdf, [223.28 kB]
; GP_HIV1_Manual de Uso_ES
pdf, [224.81 kB]
; GP_HIV1_Mode d'emploi_FR
pdf, [240.98 kB]

Declaration of Conformity

; GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 kB]
; GP_HIV1_Declaration_of_Conformity_EN
pdf, [606.74 kB]
; GP_HIV1_EC _Design_Examination Certificate_EN
pdf, [364.23 kB]
; GP_HIV1_EC_Design_Examination_Certificate_EN
pdf, [345.7 kB]

MSDS

; GP_HIV_Safety_Data_Sheet_EN
pdf, [277.24 kB]

PCR Template

; GP_HIV-1_Mic
micassay, [14.73 kB]
; GP_HIV1_ABI7500
edt, [10.33 kB]
; GP_HIV1_AriaMx
amxt, [3.63 kB]
; GP_HIV1_CroBee
fqt, [4.93 kB]
; GP_HIV1_QS3
edt, [8.01 kB]
; GP_HIV1_QS5
edt, [8.07 kB]
; GP_HIV_1_BioRad
prcl, [1.38 kB]
; RG_HIV_1
ret, [14.31 kB]

Product Leaflet

; GP_HIV1_Leaflet_EN
pdf, [131.25 kB]

Manual

; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
; SLAN Real-Time PCR System_EN
pdf, [1.53 MB]
Files are available only for registered users.

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