NIBSC - COVID-19-related research reagents

The NIBSC has a portfolio of reference and research reagents to support areas of diagnostics, vaccine development and research on COVID-19 and SARS-CoV-2.

Details are provided below to guide you to the materials most suitable to your needs. Further information is available in the Instructions for Use document associated with each material which can be accessed by clicking on the relevant NIBSC code. For any enquiries, email Standards@nibsc.org

1^st WHO International Standard for SARS-CoV-2 RNA (20/146)

Material: inactivated virus, RNA, WHO IS
Intended use: Primary calibrant for molecular assays
Description: Acid-heat inactivated SARS-CoV-2 England/2020/02, formulated in a TRIS buffer with human serum albumin, trehalose and genomic human DNA. Requires extraction prior to downstream amplification.

1^st WHO International Standard for SARS-CoV-2 antigen (21/368)

Material: inactivated virus, antigen, WHO IS

Intended use: Primary calibrant for antigen detection assays
Description: 0.01% formaldehyde-inactivated SARS-CoV-2 Omicron (B.1.1.529, sub-variant BA.1), formulated in Copan Universal Transport Medium (UTM-RT). Assigned a unitage of 5000 IU/ampoule. Reconstituted in 0.25 mL of ultra-pure water.

2^nd WHO International Standard for anti-SARS-CoV-2 immunoglobulin (21/340)

Material: Antibody, human, convalescent plasma, WHO IS
Intended use: Primary calibrant for neutralising antibodies against early SARS-CoV-2 isolates; comparator for binding antibody assays.
Description: Pool of convalescent plasma from recovered COVID-19 patients from 2020, containing high titre antibodies against SARS-CoV-2. Plasma has been solvent detergent treated to minimise the risk of presence of enveloped viruses. Traceable to the 1^st WHO International Standard for anti-SARS-CoV-2 immunoglobulin 20/136.

1^st WHO International Standard for anti-SARS-CoV-2 (variants) immunoglobulin (21/338)

Material: Antibody, human, convalescent plasma, WHO IS
Intended use: Primary calibrant for neutralising antibodies against SARS-CoV-2 variants of concern.

Description: Pool of convalescent plasma from individuals who have been infected with SARS-CoV-2 and vaccinated. Plasma has been solvent detergent treated to minimise the risk of presence of enveloped viruses.

1^st WHO Reference Panel for anti-SARS-CoV-2 (variants) immunoglobulin

Material: Antibody, human, convalescent plasma, WHO reference panel
Intended use: Assay development, Vaccine evaluation, Research, Serological assay development and evaluation

Description:comprises of 3 panel members; these are pools of convalescent plasma from recovered COVID-19 patients, infected with early 2020 isolate, or Alpha or Delta isolate. Two new panel members, pools of convalescent plasma from individuals infected with Gamma and Omicron will be available in April 2023.

Working standard for SARS-CoV-2 RNA (NIBSC code: 20/138)

Material: chimeric viral particles, RNA
Intended use: Assay development, Research - Molecular assay development; positive control for nucleic acid amplification-based assays.
Description: Chimaeric HIV-like particles containing SARS-CoV-2 RNA, formulated in a TRIS buffer with human serum albumin, trehalose and genomic human DNA. Non-infectious. Requires extraction prior to downstream amplification.

CE-marked SARS-CoV-2 NAT reagent (NIBSC code: 20/110)

Material: RNA, armoured, CE-marked.
Intended use: Diagnostics laboratories – A positive run control for routine nucleic acid amplification techniques (NAT) assays. Not for calibration purposes.

Description: In-assay performance monitoring of both the assay and operators on a day-to-day basis. CE marked under ISO 13485. Fulfils the requirements of a quality control material as described in ISO 15189.

CE-marked SARS-CoV-2 NAT Multiplex (NIBSC code: 20/170)

Material: Whole virus preparation of Influenza virus A H1N1, Influenza virus A H3N2, Influenza virus B, RSV A, RSV B and SARS-CoV-2 (VIC01), CE-marked.

Intended use: Diagnostics laboratories – A positive run control for routine nucleic acid amplification techniques (NAT) assays. Not for calibration purposes.

CE-marked SARS-CoV-2 NAT Panel (NIBSC code: 20/266)

Material: Whole virus preparation of SARS-CoV-2 (Delta) with SARS-negative viral controls (Coronavirus NL63, RSV A2, Influenza A H3N2 and Influenza virus B), CE-marked.

Intended use: Diagnostics laboratories – For verification/validation of SARS-CoV-2 nucleic acid amplification techniques (NAT) assays. Not for calibration purposes.

Description: Verification/validation of all NAT assays including RT-PCR and LAMP. CE marked under ISO 13485. Fulfils the requirements verification/validation as described in ISO 15189.

CE-marked SARS-CoV-2 Antigen Quality Control (Product code: 20/270)

Material: inactivated virus, antigen, CE marked

Intended use: Diagnostic laboratories external quality control

Description: Formulated in Copan Universal Transport Medium (UTM-RT), 0.1 mL volume. No unitage has been assigned. Product has been designed to be a suitable concentration to act as a quality control to assure the performance of tests for the detection of SARS-CoV-2 antigen in swab samples (primarily instrument-read tests).

External Quality Control Reagent for anti-SARS-CoV-2 antibody (NIBSC code: 20/B764)

Material: Antibody, human, convalescent plasma, CE-marked
Intended use: Diagnostics laboratories Quality Control reagent
Description: External Quality Control to monitor the assay performance, equipment and operators on a run to run or day to day basis. CE marked under ISO 13485. Fulfils the requirements of a reference material as described in ISO 1518

Research Materials

The materials listed below are available from the Centre for Aids Reagents (CFAR) through and will required the completion of a Material Transfer Agreement.