Virus Screening

The Virus Screening PCR Kit (VSPK) is designed for the  simultaneous NAT blood screening for the parameters HCV, HBV, HIV-1, HIV-2, HAV und PB19.

Blood Screening

The Virus Screening PCR Kit (VSPK) is a ready-to-use system for the detection of HIV-1 and HIV-2 RNA, HCV RNA, HBV DNA, HAV RNA and PB19 DNA by reverse transcription (RT), amplification (Real-Time Polymerase Chain-Reaction, Real-Time PCR) and detection using the Applied BiosystemsTM 7500® or Roche LightCycler® 480 systems.

The multiplex kit allows the simultaneous screening of mini pools from up to 96 donors and must be used with the autoX-System. It includes the proprietary triple target technology for HIV-1.

The Virus Screening PCR Kit is supplemented with an internal control (IC) as a second heterologous non-competitive amplification system to monitor the nucleic acid extraction and PCR amplification process.

Sensitivity: 95% Limit of Detection (95% LOD) for Roche LightCycler® 480
Analyte (PCR version)
Reference material
Individual samples
sample volume 100 μl
Sample pools (n = 96)
100 μl per sample
HCV (v1)
quant. FFP
98 IU/ml1513 IU/ml
HCV (v1)
PEI standard 3443/04
not validated1866 IU/ml
HBV (v1)
WHO 2nd IS 97/750
53 IU/ml116 IU/ml
HIV-1 (v3)
WHO 3rd IS 10/152
351 IU/ml730 IU/ml
HIV-2 (v1)
quant. CCS
92 cop/ml
398 IU/ml
688 cop/ml
2979 IU/ml
HAV (v1)
WHO 1st IS 00/560
40 IU/ml53 IU/ml
PB19 (v2)
WHO 2nd IS 99/800
518 IU/ml1095 IU/ml

FFP: frozen fresh plasma; CCS: cell culture supernatant; IS: International Standard
conversion factor from cop/ml to IU/ml = 4.3 (determined using WHO 1st Int. Std. for HIV-2)

Sensitivity: 95% Limit of Detection (95% LOD) for Applied BiosystemsTM 7500
Analyte (PCR version)
Reference material
Individual samples
sample volume 100 μl
Sample pools (n = 96)
100 μl per sample
HCV (v1)
WHO 2nd IS 96/798
96 IU/ml1011 IU/ml
HBV (v1)
WHO 2nd IS 97/750
64 IU/ml181 IU/ml
HIV-1 (v3)
WHO 3rd IS 10/152
378 IU/ml800 IU/ml
HIV-2 (v1)
quant. CCS
375 cop/ml
1624 IU/ml
2858 cop/ml
12375 IU/ml
HAV (v1)
WHO 1st IS 00/560
85 IU/ml61 IU/ml
PB19 (v2)
WHO 2nd IS 99/800
392 IU/ml707 IU/ml

FFP: frozen fresh plasma; CCS: cell culture supernatant; IS: International Standard
conversion factor from cop/ml to IU/ml = 4.33 (determined using WHO 1st Int. Std. for HIV-2)

Specificity of individual samples for Roche LightCycler® 480 (EDTA plasma)
Analyte
(PCR version)
Specificity
HCV (v1)100%
HBV (v1)100%
HIV-1 (v3)100%
HIV-2 (v1)100%
HAV (v1)100%
PB19 (v2)100%
Genotype detection
VirusGenotype / Subtype
HCV1 – 6
HBVA – H
HIV-1M (= A – K), N, O, P, recombinant forms
HIV-2A, B, D, I
HAV1 – 3
PB191 – 3

For details please refer to the product information document.

Virus Screening PCR Kit
Virus Screening PCR Kit (version 1.3)
GFE order number
Number of reactions per kit

001-12-10
12 analyses for 6 viruses
packing unit = 10 kits
001-24-10
24 analyses for 6 viruses
Kit components:
Basismix v2
Oligomix HCV-HBV Multiplex-PCR v1
Oligomix HIV-1 PCR v3
Oligomix HIV-2-HAV Multiplex-PCR v1
Oligomix Parvovirus B19 PCR v2
PCR version

PCR version 1
PCR version 3
PCR version 1
PCR version 2
Label
BM
O_BC
O_i1
O_i2A
O_B19

Intended Use

The Virus Screening PCR Kit is designed for the qualitative detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, hepatitis B virus (HBV) DNA, hepatitis A virus (HAV) RNA and parvovirus B19 (PB19) DNA in human EDTA plasma, which as been donated in the context of blood banking.

The Virus Screening PCR Kit is intended for the screening of human plasma samples from individual donors or pooled human plasma samples consisting of 2 to 96 individual donations.

The Virus Screening PCR Kit is intended for use with the Applied BiosystemsTM 7500 Real-Time PCR System or with the Roche LightCycler® 480 II Real-Time PCR System in conjunction with GFE’s autoX-System. The kit must exclusively be used with the appropriate accessory kits supplied by GFE.

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