COVD432 SARS-CoV-2 Molecular
The COVD program is designed as an External Quality Assessment (EQA) program to complement quality assurance activities of laboratories performing molecular testing on SARS-CoV-2.
The samples for the COVD program consist of human fibroblast cells with or without SARS-CoV-2 whole genome cDNA desiccated on a FLOQSwab™. The swabs are designed for nucleic acid tests (NAT) that detect SARS-CoV-2 in human nasopharyngeal or oropharyngeal swab specimens. The raw material used to prepare the sample material has been inactivated. Using whole genome material means the sample material contains all possible gene targets thus closely resembling patient samples and ensures NAT platforms can detect the virus, regardless of the gene target(s) used by their platform/protocol.
Samples - FLOQSwab™. Samples are desiccated and not contained in transport medium. Participants will perform elution according to kit manufacturers’ procedures. Samples are single-use only and should not be reused once opened.
Program Format - 2 samples x 3 test events.
Storage - Room temperature (15-30°c / 59-86°F)
Compatibility - All NAT tests that detect specific gene targets of SARS-CoV-2. Note: Specific levels of reactivity when Sample Adequacy Control (SAC) is used will vary among different assays/procedures/laboratories
Result submission and evaluation - Participants can report instrument readings (if applicable), but
grading will be performed on the interpretation of their assay results
COVS436 SARS-CoV-2 Serology
The COVS program is designed as an External Quality Assessment (EQA) program to complement quality assurance activities of laboratories performing serology testing on SARS-CoV-2. This program provides donor-sourced human plasma with IgA, IgG, and/or IgM antibodies against SARS-CoV-2 and will be sourced as single-donor material whenever possible. Clinical histories on the donors will be provided on performance reports.
Samples - liquid human plasma (0.5 mL per sample).
Program Format - 6 samples x 3 test events.
Storage - 2-8 °c / 36-46°F.
Compatibility - Serological methods, included ELISA, rapid lateral-flow assays, immunofluorescence, chemiluminescence, and electrochemiluminescence
Result submission and evaluation - Participants can report instrument readings (if applicable), but grading will be performed on the interpretation of their assay results
COVQ8110LN/LP/SN/SP SARS-CoV-2 Molecular QC
The COVQ program provides internal quality control (IQC) material to monitor performance for each test run, and are designed for NAT tests that detect SARS-CoV-2 in human nasopharyngeal, oropharyngeal, nasal mid-turbinate, anterior nares and lower respiratory samples.
The samples for the COVQ program consist of human fibroblast cells with or without SARS-CoV-2 whole genome cDNA and there are two sample choices - swabs with sample material desiccated on FLOQSwab™, or liquid where cells are suspended in an alcohol solution.
The raw material used to prepare the sample material has been inactivated. Using whole genome material means the sample material contains all possible gene targets thus closely resembling patient samples and ensures NAT platforms can detect the virus, regardless of the gene target(s) used by their platform/protocol.
Samples - Swabs or liquid (0.5 mL per sample). For swabs, samples are desiccated and are not contained in transport medium. Participants will perform elution according to the procedure outlined by the instrument/device manufacturer before testing. Samples are single-use only and should not be reused once opened.
Levels - Positive and negative
Program Format - There are 4 variations
COVQ8110LN - 10 liquid, negative
COVQ8110LP - 10 liquid, positive
COVQ8110SN - 10 swabs, negative
COVQ8110SP - 10 swabs, positive
Storage - Liquid samples are stored at 2-8 °c / 36-46°F and swabs at 2-30°c / 36-86°F until use
Compatibility - All NAT tests that detect specific gene targets of SARS-CoV-2. Note: specific levels of reactivity when Sample Adequacy Control (SAC) is used will vary among different assays/procedures/laboratories.
COVV5112L/S SARS-CoV-2 Molecular Validation
The COVV program provides positive and negative samples for NAT instruments/methods to perform verification/validation studies, or for education and R&D purposes. The samples for the COVV program consist of human fibroblast cells with or without SARS-CoV-2 whole genome cDNA and there are two sample choices - swabs with sample material desiccated on FLOQSwab™, or liquid.
The raw material used to prepare the sample material has been inactivated. The advantage of using whole genome material means the sample material contains all possible gene targets thus closely resembling patient samples and ensures NAT platforms can detect the virus, regardless of the gene target(s) used by their platform/protocol.
Samples - Swabs or liquid (0.5 mL per sample). For swabs, samples are desiccated and are not contained in transport medium. Participants will perform elution according to the procedure outlined by the instrument/device manufacturer before testing.
Program Format - There are 2 variations
COVV5112L - Liquid samples - 8 positive + 4 negative = 12 samples
COVV5112S - Swabs - 8 positive + 4 negative = 12 samples
Storage - Liquid samples are stored at 2-8 °c / 36-46°F and swabs at 2-30°c / 36-86°F until use
Compatibility - All NAT tests that detect specific gene targets of SARS-CoV-2. Note: specific levels of reactivity when Sample Adequacy Control (SAC) is used will vary among different assays/procedures/laboratories
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