Aptima HIV-1 Quant Dx—A fully automated assay for both diagnosis and quantification of HIV-1

• Published in: Journal of clinical virology Vol. 77; pp. 46 - 54
• Main Authors: Nair, Sangeetha Vijaysri, Kim, Hee Cheol, Fortunko, Jacqueline, Foote, Tracy, Peling, Tashi, Tran, Cuong, Nugent, Charles Thomas, Joo, Sunghae, Kang, Youna, Wilkins, Bana, Lednovich, Kristen, Worlock, Andrew
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.04.2016
• Subjects: Allergy and Immunology; Aptima; Automation, Laboratory; CAP/CTM; Diagnosis; HIV; HIV Infections - diagnosis; HIV Infections - virology; HIV-1 - genetics; Human immunodeficiency virus; Human immunodeficiency virus 1; Infectious Disease; Molecular Diagnostic Techniques; Panther; Reagent Kits, Diagnostic; Reproducibility of Results; Sensitivity and Specificity; Viral load; Viral Load - methods; LLOQ; anti retroviral therapy; NAAT; ART; SD; Aptima; viral load; lower limit of quantification; Diagnosis; nucleic acid amplification test; LOD; COBAS ® AmpliPrep/COBAS ® TaqMan ® HIV-1 Test v2.0; Abbott RT; Panther; Procleix ® Ultrio Elite™ discriminatory assay; Procleix; limit of detection; LOQ; Abbott RealTime HIV-1 Assay; HIV; CAP/CTM; VL; Aptima HIV-1 Quant Dx Assay; limit of quantification; standard deviation; Viral load
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2016.02.002

Highlights • Aptima was more sensitive than COBAS Ampliprep TaqMan HIV-1 version 2.0 (CAP/CTM). • In seroconversion panels Aptima detected HIV earlier than antigen/antibody tests. • Diagnostic agreement was 100% with Procleix® Ultrio Elite™ blood screening assay. • Viral load measurements in Aptima showed good agreement with CAP/CTM. • Aptima demonstrated equivalent subtype quantification and good precision.