Performance Evaluation of the Aptima Assays in Comparison with the cobas 6800 Assays for the Detection of HIV-1, HBV, and HCV in Clinical Samples

Park, Younhee; Roh, Juhye; Kim, Sinyoung

doi:10.3343/alm.2022.42.4.447

Cited by 8 publications

(3 citation statements)

References 33 publications

(53 reference statements)

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“…Except for ADVIA Centaur XPT, all CVs of the 10 positive candidate standards were < 10%. Because the WHO anti-HIV-1 antibody international reference standard is not designated in the form of international units, internationally used HIV antibody assay devices are qualitative assays [10,11]. The aim of this multi-center collaborative study was not to assign specific values (property values) of candidate standards but rather to confirm the presence of anti-HIV-1 antibody and measure the values of candidate standards using different assays.…”

Section: Discussionmentioning

confidence: 99%

Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody

et al. 2022

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Background: National reference standards for anti-HIV-1 antibody are needed to evaluate the performance and maintain the quality control of anti-HIV-1 antibody assays. The aim of this study was to prepare a mixed-titer performance panel and assess its suitability as a national reference standard for anti-HIV-1 antibody according to stability, collaboration, and other studies.Methods: Nineteen serum samples from different HIV patients were obtained, along with 15 units of fresh frozen plasma samples with negative anti-HIV-1 antibody results. Ten anti-HIV-1 antibody-positive candidate standards and two negative candidate standards were prepared based on the reactivity in the Alinity i HIV Ag/Ab combo assay (Abbott Laboratories, Wiesbaden, Germany). A collaborative study was conducted across eight laboratories using five anti-HIV-1 antibody assays. Real-time and accelerated stability were evaluated to assess the long-term stability.Results: In the collaborative study, results of all five anti-HIV-1 antibody assays were positive for all 10 candidate standards prepared using HIV patient samples. The CV of each assay for every candidate standard was within 10%, except for one assay result. No real-time and accelerated stability change trend was observed at −70°C or −20°C, supporting that the reference standards were maintained in a stable state at −70°C for long-term storage. Conclusions:The overall results suggest that the 12 candidate standards could serve as national reference standards for anti-HIV-1 antibody.

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Section: Discussionmentioning

confidence: 99%

Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody

et al. 2022

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“…The main identified risk of this low-level viremia (LLV, variably defined as 20–200 copies/mL on ≥2 occasions) is an association with future virologic failure [ 13 , 14 ]. It is also important to consider that VL assays lose precision at lower values of HIV RNA, potentially contributing to the observation of values that are continuously above the LLD [ 15 , 16 ]. Yet it has not been established that identification of LLV or virological blips (single instances of detectable VLs <200 copies/mL) lead to actions that successfully prevent future virologic failure.…”

Section: Overly Sensitive Viral Load Testing Challengesmentioning

confidence: 99%

The Perils of Overly Sensitive Viral Load Testing for Persons With Human Immunodeficiency Virus

Rodriguez,

Syros,

Rodriguez

et al. 2023

Open Forum Infectious Diseases

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The concept of undetectable = untransmittable (“U = U”) has been revolutionary both in the prevention and treatment of persons living with HIV. Most studies proving the concept of U = U used an HIV viral load cutoff of 200 copies/mL to define being undetectable. Since then, increasingly sensitive commercial viral load assays, sometimes down to a lower limit of detection (LLD) of 20 copies/mL, lead to confusion about the definition of undetectable and when someone is truly considered untransmittable. Viral loads between the LLD and 200 copies/mL have been associated with future virologic failure; however, no data exist to suggest that intervening in those patients leads to any meaningful benefits. In the absence of a demonstrable benefits of reporting such low viral loads, we view this practice as harmful. We suggest recommendations for adjusting viral load reporting, improving provider counseling, and call for research designs to mitigate the harms of overly-sensitive viral load testing.

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“…Among the molecular methods used for VL quantification, real-time nucleic acid amplification tests are considered the gold standard because of their higher sensitivity and wider range of measurements [7][8][9]. Automated systems with high testing volumes in clinical laboratories have been developed and are widely used.…”

Section: Introductionmentioning

confidence: 99%

Performance Evaluation of the Roche Cobas 5800 HBV and HCV Tests: Comparison of the 200 and 500 μL Protocols

Jeong,

Lee,

Cho

et al. 2023

Ann Lab Med

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Background: Clinical management of patients infected with hepatitis B virus (HBV) or hepatitis C virus (HCV) relies on the viral load (VL). The Cobas 5800 system (Roche Diagnostics) can determine VLs in 200 and 500 µL samples, but the performance of each protocol has not been compared. We evaluated the performance of both protocols for the HBV and HCV tests.Methods: Precision and linearity were verified using commercial panels. Probit analyses were used to determine limits of detection (LoDs). The results obtained with 336 samples were compared using the 200 and 500 µL protocols. Data from 6,737 retrospective HBV and 768 HCV samples were compared to estimate the effects of the different LoDs on the diagnostic results of the protocols. Correlations between protocols were tested with Spearman's rank correlation coefficients (rho). Results:The precision and linearity of both protocols were verified. The LoDs for the 200 and 500 μL protocols were 6.5 and 2.7 IU/mL for HBV and 29.7 and 8.2 IU/mL for HCV, respectively. The agreement between the protocols ranged from 0.8 to 1.0. The results obtained with the HBV and HCV tests showed a strong correlation (rho = 0.994). Only 0.4% of HBV and 0.4% of HCV test results were affected by the LoDs of the 200 μL protocol. Conclusions:The Cobas 5800 200 and 500 µL protocols for the HBV DNA and HCV RNA tests demonstrated excellent performance. These findings establish the 200 µL protocol as a new option for low-volume samples, especially for pediatric and difficult-to-bleed patients.

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Performance Evaluation of the Aptima Assays in Comparison with the cobas 6800 Assays for the Detection of HIV-1, HBV, and HCV in Clinical Samples

Cited by 8 publications

References 33 publications

Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody

Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody

The Perils of Overly Sensitive Viral Load Testing for Persons With Human Immunodeficiency Virus

Performance Evaluation of the Roche Cobas 5800 HBV and HCV Tests: Comparison of the 200 and 500 μL Protocols

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