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Practical approach to method verification in plasma and validation in cerebrospinal fluid under accreditation using a flexible scope in molecular virology: setting up the HIV, HBV and HCV Aptima™ Quant Dx assays

Abstract : Abstract Background Our laboratory obtained the ISO 15189 accreditation for the plasmatic HIV-1, HBV and HCV viral load (VL) using the m2000 RealTi m e™ system, which was recently changed for the platform Panther ® . Here, we discuss a strategy for performing method validation/verification very quickly. Methods We performed the mandatory (repeatability, internal quality assessment [IQA], measurement uncertainty [MU]) and optional technical verifications for CE/IVD assays using the flexible scope range A. We also performed the mandatory assays for the validation of HIV-1 VL in the cerebrospinal fluid (CSF) using the flexible scope range B. The change was checked by following up on the turnaround time (TAT). Results The coefficient of variation (CV%) for repeatability and IQA complied with the limit of 0.25 log. The MU results ranged from 0.04 to 0.25 log copies or IU/mL. The comparisons of methods showed excellent correlations (R 2 = 0.96 for the three parameters) but a delayed centrifugation on HCV VL showed variations of up to 2 log IU/mL. An excellent linearity for HIV-1 in the CSF was obtained from 1.5 to 5 log copies/mL with R 2 = 0.99. The TAT increased (84%–98%) in routine usage. Conclusions The three Aptima assays are well suited for routine laboratory use and can be integrated within less than 2 weeks in accordance with flexible scope range A. Our data allows us to confidently perform HIV-1 VL in CSF following flexible scope range B. Finally, we provide an organizational guide for flexible scope management in molecular virology within a short time frame.
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https://hal.univ-angers.fr/hal-03443233
Contributeur : Véronique Bourgeais Connectez-vous pour contacter le contributeur
Soumis le : mardi 23 novembre 2021 - 14:25:26
Dernière modification le : mercredi 20 avril 2022 - 13:06:05

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Caroline Lefeuvre, Adeline Pivert, Cong Tran, Françoise Lunel-Fabiani, Alexandra Ducancelle, et al.. Practical approach to method verification in plasma and validation in cerebrospinal fluid under accreditation using a flexible scope in molecular virology: setting up the HIV, HBV and HCV Aptima™ Quant Dx assays. Clinical Chemistry and Laboratory Medicine, De Gruyter, 2020, 58 (2), pp.251-260. ⟨10.1515/cclm-2019-0502⟩. ⟨hal-03443233⟩

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