Table. 4.

Commercial reference materials available for quality control of SARS-CoV-2 testing

Product name

SARS-CoV-2 Positive/Negative Run Control (CE-IVD); SARS-CoV-2 Standard (RUO) Accuplex SARS-CoV-2 Molecular Controls Accuplex SARS-CoV-2 Reference Material AcroMetrix COVID-19 RNA Control NATtrol SARS-Related coronavirus 2 External Run Control SARS-CoV-2 (COVID-19) Q Controls
Manufacturer Bio-Rad Seracare Seracare Thermo Fisher Zeptometrix Randox Qnostics
Type Synthetic RNA Recombinant virus Recombinant virus Genomic RNA Chemically modified, inactivated viral particles Whole pathogen
Human genomic DNA background Yes Human RNAse P gene in negative control Human RNAse P gene in negative control No A549 cells as negative control Human cells/nucleic acids in negative control
Test for entire process* Yes Yes Yes No (not applicable for extraction) Yes Yes
Concentration 200,000 copies/μL 5,000 copies/μL 5,000 copies/μL 500 copies/μL (low); 100 copies/μL (ultra-low) 50,000 copies/μL (SARS-CoV-2); 50,000 cells/mL (A549) NS
Package 5×0.3 mL, positive only 5×1.5 mL (positive vials); 5×1.5 mL (negative vials) 5×1.5 mL (positive vials); 5×1.5 mL (negative vials) 2×20 μL 6×0.5 mL (SARS-CoV-2 or A549 cells) 5×0.5 mL (positive control); 5×0.5 mL (negative control)
Storage –20℃ up to 1 year 2℃–8℃ up to 2 years 2℃–8℃ up to 2 years ≤–20℃ 2℃–8℃ Frozen (single use)
Target genes ORF1ab, RdRp, S, E, N Full length ORF1a, RdRp, E, N Full length Full length Full length
Value assigned Internally value assigned by ddPCR Internally value assigned by TaqMan digital PCR NS Internally value assigned by ddPCR In-house RT-PCR and digital PCR Digital PCR
Certification and label CE-IVD or RUO CE-IVD RUO RUO RUO CE, RUO

Abbreviations: SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; CE-IVD, Conformité Européenne-in vitro diagnostics; COVID-19, coronavirus disease 2019; NS, not specified; ddPCR, Bio-Rad Droplet Digital PCR; PCR, polymerase chain reaction; RT-PCR, reverse transcription polymerase chain reaction; RUO, for research use only.

*The entire process comprises extraction, amplification, and detection.

J Lab Med Qual Assur 2020;42:194~199
© Lab Med Qual Assur