Background: Quantitation of HIV-RNA is critically important for diagnosis, prognosis, treatment, monitoring and assessment of infectivity in HIV-1 infection. The objective of this study was to assess performance characteristics of the Aptima HIV-1 Quant Dx assay (Aptima), a new transcription mediated amplification (TMA), fully integrated and automated assay from Hologic Inc., San Diego, CA, USA. The analytical sensitivity, analytical specificity, precision and detection of HIV-1 subtypes were tested based on commercially available international standards or panels. A selected group of 244 anti-HIV-1 (+) plasma samples was used for comparison with Roche COBAS Ampliprep/COBAS TaqMan HIV- 1 test v2.0 (Roche CAP/CTM), (Roche Molecular Systems, Pleasanton, CA).
Results: The 50 and 95 % limit of detection were estimated at 4.9 (95 % CI 3.9-5.7) and 17.6 (15.2-21.2) IU/mL respectively. The specificity was found 99.83 (99.06-99.97) %. The standard deviations and coefficient of variations for panels with 50 and 100 copies/mL (1.7 and 2 log copies/mL) were 0.14 log copies/mL (8.67 %CV) and 0.18 log copies/mL (9.91 %CV) respectively. The detection rate for Aptima and Roche assays was 220/244 (90.2 %) and 217/244 (88.9 %) respectively.
Conclusion: The Aptima assay is a sensitive, specific, precise and accurate test for measuring HIV-1 viral loads and for the detection of HIV-1 infections.
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http://dx.doi.org/10.1186/s12985-016-0627-y | DOI Listing |
J Antimicrob Chemother
January 2025
Service de santé publique, Inserm CESP U1018, Université Paris-Saclay, APHP. Université Paris-Saclay, le Kremlin-Bicêtre, France.
Background: Therapeutic outcomes for patients infected by genetically divergent HIV-1/O are not well-known due to scarce data and the lack of an appropriate comparison with patients infected by pandemic HIV-1/M. We aimed to compare the immunological and virological response to cART between HIV-1/O and HIV-1/M patients followed in France.
Methods: All naïve HIV-1/O subjects initiating cART in France in ANRS-ORIVAO study were compared to naïve HIV-1/M subjects initiating cART in ANRS-COPANA cohort.
Viruses
December 2024
Pharmalex India Pvt. Ltd., Noida 201301, India.
Nasal spray treatments that inhibit the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) entry into nose and nasopharynx at early stages can be an appropriate approach to stop or delay the progression of the disease. We performed a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicentric, phase II clinical trial comparing the rate of hospitalization due to COVID-19 infection between azelastine 0.1% nasal spray and placebo nasal spray treatment groups.
View Article and Find Full Text PDFInfect Dis (Lond)
January 2025
Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Background: Although recommended isolation periods for Coronavirus disease 2019 (COVID-19) have been shortened as the pandemic has subsided, prolonged Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) shedding remains common in immunocompromised patients. This study estimated the probability of viral clearance in these patients based on elapsed days and specific risk factors.
Methods: We prospectively enrolled immunocompromised patients with a confirmed COVID-19 diagnosis from January 2022 to May 2023 during the Omicron variant era.
Clin Mol Hepatol
December 2024
Department of Medicine, Queen Mary Hospital, The University of Hong Kong.
Background: Plasma pregenomic hepatitis B virus RNA (pgRNA) is a novel biomarker in chronic hepatitis B infection (CHB). We aimed to describe the longitudinal profile of pgRNA and factors influencing its levels in CHB patients on nucleoside analogue (NUC).
Methods: Serial plasma samples from 1354 CHB patients started on first-line NUC were evaluated.
Liver Int
January 2025
Phase I Clinical Trial Center, the First Hospital of Jilin University, Jilin, China.
Background And Aims: Freethiadine is a novel hepatitis B virus capsid assembly modulator. Herein, we report the safety, tolerability, pharmacokinetics and 28-day antiviral activities of freethiadine.
Methods: The study consisted of two parts.
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