GeneProof BK Virus (BKV) PCR Kit

Kat.: BKV/GP/025

Gyártó: GeneProof a.s.

 

A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.

Pontos és teljesen nyomon követhető mennyiségi meghatározás a WHO 1. nemzetközi szabványának, a NIBSC BKV 14/212-nek megfelelően. ‘Ready-To-Use’ master mix. . A nagy tumor antigént kódoló t-Ag gene szekvenciát célozza. (25 reakció)

 

 

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PRODUCT ADVANTAGES

W.H.O. STANDARD BASED QUANTIFICATION

  • Precise and fully traceable quantification according to 1st WHO International Standard NIBSC BKV 14/212
  • Enables reliable viral load monitoring

EASY-TO-USE CONCEPT

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

SIMPLE LABORATORY WORKFLOW

  • Easily combinable with other GeneProof PCR kits in one workflow

CONTAMINATION PREVENTION

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

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Technology real-time PCR
Type of Analysis qualitative and quantitative
Target Sequence T-Ag gene encoding large tumor antigen
Analytical Specificity BK virus (BKV), 100 %
Analytical Sensitivity (LoD with 95% probability) 
Sample Processing CSF Plasma Whole blood
GeneProof PathogenFree DNA Isolation Kit 240.9 IU/ml 297.0 IU/ml 251.8 IU/ml
croBEE 201A Nucleic Acid Extraction Kit 532.1 IU/ml 644.7 IU/ml 908.6 IU/ml
Diagnosis Specificity 100.00 % (CI95%: 86.27 % – 100.00 %)
Diagnosis Sensitivity 96.30 % (CI95%: 79.11 % – 99.81 %)
Positive Predictive Value 100.00 % (CI95%: 83.98 % – 100.00 %)
Negative Predictive Value 96.88 % (CI95%: 82.00 % – 99.84 %)
Linear Range 1010 – 103 IU/ml with precision of ± 0.5 log (using manual or automatic extraction from plasma, CSF
and whole blood)
Dynamic Range 1010 – LoD IU/ml (LoD varying according to the extraction and material used)
Trueness (of expected concentration)
Extraction Method CSF Plasma Whole blood
GeneProof PathogenFree DNA Isolation Kit -0.11 log
(CI95%: -0.20 – -0.02)		 -0.07 log
(CI95%: -0.14 – -0.01)		 -0.04 log
(CI95%: -0.14 – -0.01)
croBEE 201A Nucleic Acid Extraction Kit -0.12 log
(CI95%: -0.23 – -0.01)		 -0.06 log
(CI95%: -0.12 – 0.00)		 -0.07 log
(CI95%: -0.15 – 0.00)
Precision – Repeatability Intra-assay SD of log concentration = 0.061 (CI95%: 0.050 – 0.080)
Precision – Reproducibility Inter-assay SD of log concentration = 0.112 (CI95%: 0.072 – 0.246)
Inter-lot SD of log concentration = 0.206 (CI95%: 0.133 – 0.454)
Total SD of log concentration = 0.243 (CI95%: 0.157 – 0.536)
Reporting Units IU/ml
Conversion Factor 1 IU = 1 cp
Metrological Traceability 1st WHO International Standard for BK virus DNA (NIBSC code 14/212)
Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control by Internal Control
Validated Specimen CSF, plasma, urine, whole blood
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
Validated 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
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 Panels – results at www.geneproof.com

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GeneProof BK Virus (BKV) PCR Kit

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