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KMID : 0390320190290010007
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Chungbuk Medical Journal
2019 Volume.29 No. 1 p.7 ~ p.13
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Evaluation of Analytical Performance of the Abbott RealTime HIV-1 Viral Load assay
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Park Hee-Sue
Son Bo-Ra
Shin Kyeong-Seob
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Abstract
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Purpose: Quantification of Human immunodeficiency virus (HIV) vial load is critically used to determine of stage and monitor response of anti-viral treatment in patients with acquired immunodeficiency syndrome (AIDS). Abbott RealTime-HIV-1 viral load assay using m2000 instrument is fully automated system based on real-time reverse-transcriptase polymerase chain reaction. Here, we evaluated the analytical performance of this newly adopted assay.
Material and Methods: The precision, linearity and sensitivity of detection comparing to previous commercial laboratory results (Roche Cobas 6800 system), were evaluated.
Results: The within run precision for HIV viral load were 2.4% in low concentration and 1.6% in high concentration, respectively. The between run precision were 1.8% in low concentrations and 1.4% in high concentration, respectively. The agreement with previous method was 99.7%. The linearity showed high linearity (R2=0.998) and sensitivity of detection for lower limit of detection level (40 copies/mL) was 100%.
Conclusions The precision, linearity and agreement of previous method were excellent in this study. Therefore, it is possible to provide test results faster as it plays an important role in determine treatment decision.
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KEYWORD
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HIV quantification test, Viral load assay, Evaluation of performance
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