Korean J Blood Transfus.  2018 Aug;29(2):171-181. 10.17945/kjbt.2018.29.2.171.

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

• Choi KY
• Youn KW
• Cha YJ
• Min HK
• Kim J

• KMID: 2435675
• DOI: http://doi.org/10.17945/kjbt.2018.29.2.171

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.

Keyword

National reference standard; Real-time stability; HBV; HCV; HIV-1

MeSH Terms

DNA, Recombinant
Hepacivirus
Hepatitis B virus
HIV-1*
Humans
In Vitro Techniques*
Nucleic Acid Amplification Techniques*
Reagent Kits, Diagnostic*
Viral Load
DNA, Recombinant
Reagent Kits, Diagnostic