HIV-1 Confirmation

The Confirmatory PCR Kit HIV-1 with its proprietary triple target technology is designed for the automated or manual confirmation testing of initially positive screening results.

Confirmatory PCR Kit HIV-1

The Confirmatory PCR Kit HIV‑1 is used to detect Human Immunodeficiency Virus-1 (HIV‑1) RNA by Reverse Transcription (RT), amplification (Real-Time Polymerase-Chain-Reaction, Real-Time PCR) and detection using the Roche LightCycler® 480 II Real-Time PCR System.

The kit takes advantage of the triple target HIV-1 PCR.

Sensitivity: 95% Limit of Detection (95% LOD)
Analyte
Reference material
Confirmatory sample volume 400 μl
Roche LightCycler® 480 (autoX-System)
Confirmatory sample volume 380 μl
Roche LightCycler® 480 / MinElute (manual handling)
HIV 1
WHO 3rd Int. Std.
10/152

68.6 IU/ml
[CI: 46.8 – 165.3]
13.7 IU/ml
[CI: 9.3 – 38.3]
Specificity, autoX-System (Roche LightCycler® 480)
Analyte
Specificity
Individual samples100%
Specificity, manual handling (Roche LightCycler® 480 / MinElute®)
Analyte
Specificity
Pooled plasma samples100%
Individual samples100%
Genotype detection
VirusGenotype / Subtype
HIV-1A – D, F, G, H, O, AG, AE

For details please refer to the product information document.

Confirmatory PCR Kit HIV-1
Confirmatory PCR Kit HIV-1 (version 1.2)
GFE order number
Number of reactions per kit


Automated handling (autoX-System)

Manual handling

packing unit = 20 kits
005-08-20
8 analyses for 8 viruses

12 analytes for 1 virus

Kit components:
Basismix v2
Oligomix HIV-1 v3 (PCR version 3)
Volume [µl]
810
100
Label
BM
O_i1

Intended Use

The Confirmatory PCR Kit HIV‑1 is designed for the qualitative detection of Human Immunodeficiency Virus-1 (HIV‑1) RNA in human EDTA plasma from blood donations. The kit allows for a highly sensitive analysis in accordance with Votum 34 of the German National Advisory Committee ‘Blood’ (Arbeitskreis Blut) of the German Federal Ministry of Health.

The kit is intended to confirm HIV‑1 positive screening results in human EDTA plasma samples by analysis of repository samples or consecutive blood samples of individual donors.

The Confirmatory PCR Kit HIV‑1 is intended for use with the Roche LightCycler® 480 II Real-Time PCR System in conjunction with the GFE autoX-System and the respective GFE accessory and control kits.

The Confirmatory PCR Kit HIV‑1 is also intended for use with the Roche LightCycler® 480 II Real-Time PCR System in conjunction with the QIAamp® MinElute® Virus Spin Kit for nucleic acid extraction and the respective GFE control kits (IC Kit, PCR Positive Control Kit, NTC Kit).

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