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VERSANT HIV-1 RNA 1.5 Assay (kPCR)Highly Sensitive HIV Viral Load Assay for use on the VERSANT® kPCR Molecular System

In vitro diagnostics, IVD assays - VERSANT HIV-1 RNA 1.5 Assay (kPCR)
VERSANT HIV-I RNA 1.5 Assay (kPCR)

The VERSANT® HIV-1 RNA 1.5 Assay (kPCR)* is an in vitro nucleic acid amplification assay used for quantitative measurement of human immunodeficiency virus (HIV-1) RNA in plasma samples. This assay is performed on the VERSANT® kPCR Molecular System*. Combined with Siemens’ nucleic acid extraction technology, this assay provides a reliable and sensitive method for the quantitation of human HIV-1 in infected individuals.

  • Outstanding Assay Performance
  • Automated and Flexible Technology
  • Robust Assay Design
  • Optimal Assay Standardization

Fonctionnalités et avantages

Performance to meet your needs

  • Efficient and reproducible extraction, amplification, and detection of HIV-1 RNA
  • Up to 89 patient samples per run
  • Results in less than 6 hours

Outstanding Assay Performance

  • Excellent performance with quality extraction
  • Low limit of detection (LOD) with high accuracy
  • Good precision across a wide dynamic range
  • Compatible with a variety of subtypes and circulating recombinant forms

Automated and Flexible Technology

  • Primary-tube sampling supports a variety of tube types and sizes
  • Positive patient sample identification with bar-code ID for sample and results tracking
  • Up to 178 patient results per shift
  • 500 uL sample input volume

Robust Assay Design

  • Enhanced sensitivity and specificity with BLACK HOLE QUENCHER**
  • Detects HIV-1 group M clades A–H, CRF, and group O
  • Targets highly conserved pol integrase gene with unique TAQMAN*** probes
  • Lower annealing temperature tolerates greater mismatch which leads to better subtype quantitation
  • Dual-primer and triple probe design to increase mismatch tolerance
  • Non-competitive internal control to monitor extraction and PCR efficiency
  • Amplicon contamination control with UNG

 

HIV Assay Workflow

Assay Workflow

Caractéristiques techniques

Optimal Assay Standardization

  • Calibration is performed during each run which provides quality results
  • Accurate calibration is achieved with efficient extraction of calibrator transcripts which are similar in size to HIV viral transcripts
  • Gold standard phosphate method is used to establish copies/mL
  • Referenced to the WHO HIV RNA 2nd International Standard (97/650) for IU/mL

Charcteristic

Performance

Sensitivity

37 copies/mL

Specificity

99.7% with a 95% lower confidence limit of 99.3%

Dynamic Range

37 to 11,000,000 copies/mL

Linearity

The maximum deviation from linearity at all levels of dynamic range within +/- 0.10 log copies/mL

Genotype Inclusivity

HIV-1 group M clades A–H, CRF, and group O

VERSANT HIV-1 RNA 1.5 Assay for quantitative measurement of HIV RNA in fresh or frozen human plasma samples

10729727

VERSANT®  HIV-1 RN1.5 Assay (kPCR), IVDD, Box 1

(96 tests)

10729728

VERSANT®  HIV-1 RNA 1.5 Assay (kPCR), IVDD, Box 2

(4 sets Calibrators and Controls)

*Not for sale in the US.

Assays currently available on the VERSANT kPCR Molecular System.

VERSANT is a registered trademark of Siemens Healthcare Diagnostics Inc. All other marks are the property of their respective owners

Assays currently available on the VERSANT kPCR Molecular System.

* IVDD, CE marked. Not available for sale in the U.S. Product availability varies from country to country and is subject to local regulatory requirements.

Assays currently available on the VERSANT kPCR Molecular System.


The VERSANT® HIV-1 RNA 1.5 Assay (kPCR) is IVDD, CE marked.


*Not for sale in the US. Not yet available for sale in all countries.


** BLACK HOLE QUENCHER is a trademark of Biosearch Technology.


*** TaqMan is a trademark of Roche Molecular Diagnostics, Inc.

The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens organization for further details.