OVERVIEW
OVERVIEW MPOX VIRUS CONTROLS SARS-COV-2 CONTROLS RESPIRATORY VIRUS CONTROLS RESOURCES
Overview
Mpox Virus Controls
SARS-CoV-2 Controls
The use of positive controls in quality control

Twist has created synthetic RNA controls for several viral genomes. These variants were selected to cover a wide range of sequence diversity. Each control consists of six non-overlapping 5 kb fragments generated from Twist Gene Fragments then transcribed into ssRNA. These controls provide coverage of greater than 99.9% of the bases of the SARS-CoV-2 viral genome. The majority of the controls are provided in the standard format which consist of 100 μL at a concentration of approximately one million copies per microliter. Twist also offers certain controls in Assay Ready and Encapsulated Formats that are supplied as a desiccated pellet. The Assay Ready Controls are supplied at approximately two million copies per tube. The Encapsulated Controls are supplied at approximately 50,000 copies per tube. The Twist Assay Ready Synthetic SARS-CoV-2 RNA Control was developed in partnership with the US CDC and integrated into the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, which tests for influenza A, B and SARS-CoV-2 simultaneously. The Twist Assay Ready Synthetic SARS-CoV-2 RNA Control is now available for customers outside the CDC. 

Twist Bioscience Encapsulated Control products offer a unique storage and delivery method for Twist’s established Synthetic SARS-CoV-2 RNA controls. Just as protein encapsulation of viruses offers more stable molecular storage, Twist’s Encapsulated Control products leverage a novel method to seal a metal capsule around a desiccated pellet to enhance stability of the RNA controls. Due to the enhanced stability, they can be shipped and stored at room temperature, reducing cost and improving accessibility globally. The Encapsulated Controls are sold in a rack of 16 or 96 tubes, are single use, and have a 5-year shelf life from the date of manufacture.

Available SARS-CoV-2 Controls

Best practices for using Assay Ready and Encapsulated Controls

For the Storage and use of Assay Ready or Encapsulated SARS-CoV-2 Controls please review the Following documents:


This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, along with the identification and differentiation of SARS-CoV-2 PANGO lineages and the identification of specific SARS-CoV-2 genomic mutations, not for any other viruses or pathogens; and, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

NGS SARS-CoV-2 Synthetic RNA Controls Genome

 

 

PART # CONTROL GenBank/GISAID ID GISAID NAME
102019 Control 1 MT007544.1 Australia/VIC01/2020
102024 Control 2 MN908947.3 Wuhan-Hu-1
103925 Assay Ready Control 2 MN908947.3 Wuhan-Hu-1
104422 Encapsulated Control 2 (16) MN908947.3 Wuhan-Hu-1
104426 Encapsulated Control 2 (96) MN908947.3 Wuhan-Hu-1
102860 Control 3 LC528232.1 Japan/Hu_DP_Kng_19-020/2020
102862 Control 4 MT106054.1 USA/TX1/2020
102917 Control 5 MT188340 USA/MN2-MDH2/2020
102918 Control 6 MT118835 USA/CA9/2020
103087 Control 7 EPI_ISL_418227 France/HF2393/2020
103511 Control 8 MT066176 Taiwan/NTU02/2020
103512 Control 9 MT152824 USA/WA2/2020
103513 Control 10 EPI_ISL_414648 USA/CA-PC101P/2020
103514 Control 11 EPI_ISL_417739 Iceland/5/2020
103515 Control 12 EPI_ISL_420244 England/SHEF-C05B2/2020
103533 Control 13 EPI_ISL_421184 Belgium/ULG-10004/2020
103907 Control 14
Alpha
EPI_ISL_710528 England/205041766/2020
103926 Assay Ready Control 14
Alpha (B.1.1.7)
EPI_ISL_710528 England/205041766/2020
103909 Control 15
Alpha
EPI_ISL_601443 England/MILK-9E05B3/2020
103927

Assay Ready Control 15
Alpha (B.1.1.7)

EPI_ISL_601443 England/MILK-9E05B3/2020
104043 Control 16
Beta (B.1.351)
EPI_ISL_678597 South Africa/KRISP-EC-K005299/2020
104044 Control 17
Gamma (P.1)
EPI_ISL_792683 Japan (Brazil) /IC-0564/2021
104338

Control 18
Kappa (B.1.617.1)

EPI_ISL_1662307 India/CT-ILSGS00361/2021
104529

Control 19
Iota (B.1.526)

EPI_ISL_1300881 USA/NY-MSHSPSP-PV24650/2020
104530 Control 20 (B.1.427) EPI_ISL_730092 USA/CA-ALSR-4704/2020
104531

Control 21
Epsilon (B.1.429)

EPI_ISL_672365 USA/CA-CZB-12943/2020
104532 Control 22 (B1.1.519) EPI_ISL_933685 Mexico/CMX-InDRE_208/2021

104533

Control 23
Delta (B.1.617.2)
EPI_ISL_1544014 India/MH-NCCS-P1162000182735/2021
104534 Control 24
(B.1.617.3)
EPI_ISL_1939891 India/MH-SEQ-221_S66_R1_001/2021
104538

Control 28  
Delta (AY.1)

EPI_ISL_2695467 Portugal/PT9543/2021
104423 Encapsulated Control 28 (16) Delta (AY.1) EPI_ISL_2695467 Portugal/PT9543/2021
104427 Encapsulated Control 28 (96) Delta (AY.1) EPI_ISL_2695467 Portugal/PT9543/2021
104539

Control 29  
Delta (AY.2)

EPI_ISL_2693246 USA/WA-CDC-UW21061750277/2021
105204 Control 48 (B.1.1.529/BA.1) EPI_ISL_6841980 Hong Kong/HKU-211129-001/2021
104424 Encapsulated Control 48 (16)
(B.1.1.529/BA.1)
EPI_ISL_6841980 Hong Kong/HKU-211129-001/2021
104428 Encapsulated Control 48 (96)
(B.1.1.529/BA.1)
EPI_ISL_6841980

Hong Kong/HKU-211129-001/2021

105345 Control 50 (B.1.1.529+BA.2) EPI_ISL_7190366 Australia/QLD2568/2021
105346 Control 51 (B.1.1.529+BA.2) EPI_ISL_7718520 England/MILK-2DF642C/2021
105865 Control 62 (B.2.12.1) EPI_ISL_12248637.1 Denmark/DCGC-493190/2022
105857 Control 63 (B.2.12.1)

 EPI_ISL_12303256.1

USA/NY-CDC-LC0579415/2022
106196 Control 64 (BA.5) EPI_ISL_12516495 hCoV-19/England/LSPA-3DC1269/2022
106197 Control 65 (BA.5) EPI_ISL_12620611 hCoV-19/USA/TN-ASC-210769476/2022
106198 Control 66 (BA.4) EPI_ISL_12454576 hCoV-19/USA/TX-HMH-M-96682/2022
106199 Control 67 (BA.4) EPI_ISL_12605687 hCoV-19/USA/CA-CDC-QDX36065390/202

106929

Control 70

EPI_ISL_14829147

hCoV-19/USA/MI-CDC-QDX40579621/2022

106930

Control 71

EPI_ISL_15381979

hCoV-19/Australia/SA464919/2022

 

 

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