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  5. VERSANT HIV-1 RNA 1.5 Assay (kPCR)

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

Features & Benefits

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

Technical Details

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 RN 1.5 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.

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

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

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

* 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.

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.