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GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit

CE 1023 IVD New product

PRODUCT ADVANTAGES 

 

DUAL TARGET DETECTION

  • Protection against detection failures caused by virus mutations

QUALITATIVE AND QUANTITATIVE DETECTION

  • Monitoring of pathogen level in time
  • Full traceability to WHO standard

EASY-TO-USE CONCEPT

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

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

 

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) Diagnostic PCR Kit HIV1D/GP/025 real-time PCR 25 reactions
GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit HIV1D/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_HIV1D_QCMD_04_22_EN_02
pdf, [196.38 kB]
; GP_HIV1D_QCMD_04_22_EN_01
pdf, [196.37 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE1023 IVD
Intended User For professional use in laboratories with trained staff
Technology Real-time PCR
Type of Analysis Qualitative and quantitative
Target Sequence

LTR sequence, gag/pol gene boundary and gag gene

Analytical Specificity

HIV subtypes A – D, AE, F, G, AG-GH, BF, H, K, CRF03_AB, Group N, Group O – 100 %

Analytical Sensitivity (LoD with 95% probability)
Sample Processing Plasma Serum
GeneProof PathogenFree RNA Isolation Kit 129.6 IU/ml, i.e. 71.3 cp/ml 213.5 IU/ml, i.e. 117.4 cp/ml
croBEE 201A Nucleic Acid Extraction Kit 404.5 IU/ml, i.e. 222.5 cp/ml 253.9 IU/ml, i.e. 139.65 cp/ml
MagCore Automated NA Extractor 58.8 IU/ml, i.e. 32.4 cp/ml 70.6 IU/ml, i.e. 38.84 cp/ml
Diagnostic Specificity 100 % (CI95% : 99.05 % - 100 %)
Diagnostic Sensitivity 

95.41 % (CI95% : 89.10 % - 98.30 %)

Positive Predictive Value 100 % (CI95% : 95.56 % - 100.00 %)
Negative Predictive Value 100 % (CI95% : 99.05 % - 100.00 %)
Linear Range
Extraction Method Precision Plasma Serum
GeneProof PathogenFree RNA Isolation Kit ± 0.5 log 109 – 102.5 IU/ml 109 – 103 IU/ml
croBEE 201A Nucleic Acid Extraction Kit ± 0.5 log 109 – 103 IU/ml 109 – 103 IU/ml
MagCore Automated NA Extractor ± 0.5 log 109 – 102.5 IU/ml 109 – 103 IU/ml
Dynamic Range

109 IU/ml – LoD (LoD varying according to the extraction and material used)

Trueness
Extraction Method Plasma Serum
GeneProof PathogenFree RNA Isolation Kit -0.02 log (CI95%: -0.10 – 0.06) -0.09 log (CI95%: -0.22 – 0.04)
croBEE 201A Nucleic Acid Extraction Kit -0.09 log (CI95%: -0.16 – -0.01) -0.32 log (CI95%: -0.42 – -0.21)
MagCore Automated NA Extractor -0.36 log (CI95%: -0.42 – -0.29) -0.36 log (CI95%: -0.42 – -0.31)
Precision – Repeatability Intra-assay SD of log concentration = 0.065 (CI95%: 0.052 – 0.085)
Precision – Reproducibility Inter-assay SD of log concentration = 0.083 (CI95%: 0.054 – 0.184)
Inter-lot SD of log concentration = 0.076 (CI95%: 0.049 – 0.167)
Total SD of log concentration = 0.086 (CI95%: 0.055 – 0.189)
Reporting Units

IU/μl

Conversion Factor

1 IU = 0.55 cp

Metrological Traceability 4th HIV-1 International Standard NIBSC 16/194
Extraction/Inhibition Control PCR inhibition, reverse-transcription efficiency and RNA extraction efficiency control by Internal Control
Validated Specimen plasma (EDTA, citrate), serum
Storage -20 ± 5 °C
Validated Extraction Method croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree RNA Isolation Kit
MagCore Automated NA Extractor
Instruments

croBEE Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96, Fluorescent Quantitative Detection PCR system
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
LineGene 9600 Plus
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

Required Detection Channels FAM, HEX/JOE
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panelsresults at www.geneproof.com

 

Documentation

Instruction for Use

; GP_HIV1D_Instruction_for_Use_EN
pdf, [336.95 kB]

Declaration of Conformity

; GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 kB]
; GP_HIV1D_Declaration_of_Conformity_EN
pdf, [633.53 kB]

MSDS

; GP_HIV1D_Safety_Data_Sheet_EN
pdf, [276.53 kB]

Product Leaflet

; GP_HIV1D_Leaflet_EN
pdf, [133.92 kB]
Files are available only for registered users.

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