Home Medicine Comparative evaluation of the Aptima HIV-1 Quant Dx assay and COBAS TaqMan HIV-1 v2.0 assay using the Roche High Pure System for the quantification of HIV-1 RNA in plasma
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Comparative evaluation of the Aptima HIV-1 Quant Dx assay and COBAS TaqMan HIV-1 v2.0 assay using the Roche High Pure System for the quantification of HIV-1 RNA in plasma

  • Gunnar Schalasta EMAIL logo , Anna Börner , Andrea Speicher and Martin Enders
Published/Copyright: August 18, 2015
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 3

Abstract

Background: Quantification of human immunodeficiency virus type 1 (HIV-1) RNA in plasma has become the standard of care in the management of HIV-infected patients. There are several commercially available assays that have been implemented for the detection of HIV-1 RNA in plasma. Here, the new Hologic Aptima® HIV-1 Quant Dx assay (Aptima HIV) was compared to the Roche COBAS® TaqMan® HIV-1 Test v2.0 for use with the High Pure System (HPS/CTM).

Methods: The performance characteristics of the assays were assessed using commercially available HIV reference panels, dilution of the WHO 3rd International HIV-1 RNA International Standard (WHO-IS) and plasma from clinical specimens. Assay performance was determined by linear regression, Deming correlation analysis and Bland-Altman analysis.

Results: Testing of HIV-1 reference panels revealed excellent agreement. The 61 clinical specimens quantified in both assays were linearly associated and strongly correlated.

Conclusions: The Aptima HIV assay offers performance comparable to that of the HPS/CTM assay and, as it is run on a fully automated platform, a significantly improved workflow.

Keywords: Aptima; COBAS; HIV; quantification; TMA; viral load
Corresponding author: Gunnar Schalasta, Prof. Gisela Enders and Kollegen MVZ Rosenbergstr. 85, 70193 Stuttgart, Germany, Phone: +49 7116357140, E-mail:

Acknowledgments

This study was supported by Hologic Inc., San Diego, CA. We offer special thanks to the members of the Molecular Biology Department of the Laboratory Prof. Enders in Stuttgart, Germany for excellent technical assistance.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2015-6-5
Accepted: 2015-7-22
Published Online: 2015-8-18
Published in Print: 2016-3-1

©2016 by De Gruyter

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https://doi.org/10.1515/cclm-2015-0522
Keywords for this article
Aptima; COBAS; HIV; quantification; TMA; viral load

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. The way of prostate cancer diagnostics
  4. Review
  5. Statistical methods used in the calculation of geriatric reference intervals: a systematic review
  6. Opinion Paper
  7. The side effects of translational omics: overtesting, overdiagnosis, overtreatment
  8. Genetics and Molecular Diagnostics
  9. Rapid detection of non-deletional mutations causing α-thalassemia by multicolor melting curve analysis
  10. General Clinical Chemistry and Laboratory Medicine
  11. Patient pools and the use of “patient means” are valuable tools in quality control illustrated by a bone-specific alkaline phosphatase assay
  12. Long-term stability of glucose: 96-h study using Terumo Glycaemia tubes
  13. Glucose is stable during prolonged storage in un-centrifuged Greiner tubes with liquid citrate buffer, but not in serum and NaF/KOx tubes
  14. Croatian laboratories have a good knowledge of the proper detection and management of hemolyzed, icteric and lipemic samples
  15. Fetal exposure to ethanol: relationship between ethyl glucuronide in maternal hair during pregnancy and ethyl glucuronide in neonatal meconium
  16. Comparing the effect of isotopically labeled or structural analog internal standards on the performance of a LC-MS/MS method to determine ciclosporin A, everolimus, sirolimus and tacrolimus in whole blood
  17. Relationship between matrix metalloproteinase-9 and oxidative stress in drug-free male schizophrenia: a case control study
  18. Comparison of functional fibrinogen (FF/CFF) and FIBTEM in surgical patients – a retrospective study
  19. Reference Values and Biological Variations
  20. Assessment of serum free light chain levels in healthy adults immediately after marathon running
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  22. Cancer Diagnostics
  23. An epidemiology-based model as a tool to monitor the outbreak of inappropriateness in tumor marker requests: a national scale study
  24. Comparative analysis of prostate cancer specific biomarkers PCA3 and ERG in whole urine, urinary sediments and exosomes
  25. Infectious Diseases
  26. Comparative evaluation of the Aptima HIV-1 Quant Dx assay and COBAS TaqMan HIV-1 v2.0 assay using the Roche High Pure System for the quantification of HIV-1 RNA in plasma
  27. Evaluating the use of procalcitonin in an asymptomatic, HIV-infected antiretroviral therapy-naïve, South African cohort
  28. Diabetes
  29. Early prediction of gestational diabetes: a practical model combining clinical and biochemical markers
  30. Letters to the Editors
  31. Highly-trained dogs’ olfactory system for detecting biochemical recurrence following radical prostatectomy
  32. More on the accuracy of the Architect enzymatic assay for hemoglobin A1c and its traceability to the IFCC reference system
  33. Assessing quality from an accuracy-based HbA1c proficiency survey
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  35. Between analyser differences in chloride measurements and thus anion gap cause different interpretations of the acid-base balance
  36. Non-albumininuric proteinuria: a urinary tubular marker in the diagnosis of diabetic kidney disease
  37. International Normalized Ratio (INR) testing: analytical and clinical performance of four point-of-care devices versus central laboratory instrumentation analysis
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