2023
DOI: 10.1155/2023/7803864
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Standardization of SARS-CoV-2 Nucleic Acid Amplification Techniques by Calibration and Quantification to the First WHO International Standard for SARS-CoV-2 RNA

Abstract: Clinical decision-making regarding isolation of SARS-CoV-2 patients is usually based on semiquantitative cycle-threshold (Ct) values without standardization. However, not all molecular assays produce Ct values, and there is ongoing discussion about whether Ct values can be safely used for decision-making. In this study, we standardized two molecular assays which use different nucleic acid amplification techniques (NAAT): the Hologic Aptima SARS-CoV-2/Flu (TMA) and Roche Cobas 6800 SARS-CoV-2 assays. We calibra… Show more

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“…From January 2022 until the end of the study, PCR tests were performed on the Hologic Panther (non-Fusion) Aptima platform, which reported viral load in international units per milliliter. Follow-up was halted when the viral load was lower than 4 × 10 4 IU/ mL, as this correlates with a Ct value ≥30 and negative viral cultures [ 20 ]. Therefore, a patient with a negative PCR test or a Ct value ≥30 was considered to have cleared the virus [ 21 ].…”
Section: Methodsmentioning
confidence: 99%
“…From January 2022 until the end of the study, PCR tests were performed on the Hologic Panther (non-Fusion) Aptima platform, which reported viral load in international units per milliliter. Follow-up was halted when the viral load was lower than 4 × 10 4 IU/ mL, as this correlates with a Ct value ≥30 and negative viral cultures [ 20 ]. Therefore, a patient with a negative PCR test or a Ct value ≥30 was considered to have cleared the virus [ 21 ].…”
Section: Methodsmentioning
confidence: 99%