Long-Term Stability of HBV, HCV, and HIV-1 National Reference Standards for in vitro Diagnostic Medical Devices Intended to Be Used for the Nucleic Acid Amplification Test / 대한수혈학회지
Korean Journal of Blood Transfusion
;
: 171-181, 2018.
Article
Dans Coréen
| WPRIM
| ID: wpr-716145
ABSTRACT
BACKGROUND:
National reference standards are essential to the quality assessment and regulatory approval of in vitro diagnostic medical devices. However, the long-term stability of national reference standards has not been comprehensively secured. This study was performed to assessment on the long-term stability of the hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus-1 (HIV-1) national reference standards intended to be used for the nucleic acid amplification test (NAT).METHODS:
The viral loads of the MFDS (Korea Ministry of Food and Drug Safety) working standard and recombinant DNA for HBV, HCV, and HIV-1 were measured before and after storage at −70℃ for up to 72 months using Cobas Ampliprep/Cobas Taqman assays (Roche Molecular System, Inc., Branchburg, USA) at defined time points.RESULTS:
The viral loads of national reference standards for in vitro diagnostic medical devices of HBV, HCV, and HIV-1 stored at −70℃ for up to 72 months did not differ significantly from the baseline viral load. The changes in viral load of national reference standards of HBV, HCV, and HIV-1 tested after storage at −70℃ for up to 72 months ranged from −0.36 to 0.16 log10 IU/mL and did not exceed 0.5 log10, which is the estimated intra-assay variation of molecular tests.CONCLUSION:
The HBV, HCV, and HIV-1 national reference standards for in vitro diagnostic medical devices intended to be used for the NAT were relatively stable after long-term storage at −70℃ for up to 72 months, regardless of the initial titer.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Trousses de réactifs pour diagnostic
/
Techniques in vitro
/
ADN recombiné
/
Virus de l'hépatite B
/
VIH-1 (Virus de l'Immunodéficience Humaine de type 1)
/
Hepacivirus
/
Charge virale
/
Techniques d'amplification d'acides nucléiques
Type d'étude:
Etude diagnostique
/
Guide de pratique
Limites du sujet:
Humains
langue:
Coréen
Texte intégral:
Korean Journal of Blood Transfusion
Année:
2018
Type:
Article
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