Beckman Coulter Antibody Test Quality Control Access® SARS-CoV-2 IgM Level 1, 2 3 X 4 mL per Leve...
| Item Id | 1172373 |
| MF Id# | C58959 |
| Brand | Access® |
| Manufacturer | Beckman Coulter |
| Country of Origin | United States |
| Application | Quality Control |
| Container Type | Vial |
| For Use With | For Monitoring System Performance of the Access SARS-CoV-2 IgM Assay on the Access Family of Immunoassay Systems only |
| Form | Liquid |
| Levels | Level 1, 2 |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Storage Requirements | Requires Refrigeration |
| Test Name | SARS-CoV-2 IgM |
| Test Type | Antibody Test |
| UNSPSC Code | 41116145 |
| Volume | 3 X 4 mL per Level |
Features
- The Access SARS-CoV-2 IgM Assay is only for use under the FDA's Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests
- Access SARS%XE2%X80?CoV%XE2%X80?2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS%XE2%X80?CoV%XE2%X80?2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate)
- Access SARS%XE2%X80?CoV%XE2%X80?2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS%XE2%X80?CoV%XE2%X80?2, indicating recent or prior infection; at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
- The sensitivity of the Access SARS-CoV-2 IgM assay early after infection is unknown; negative results do not preclude acute SARS-CoV-2 infection
- False positive results for the Access SARS%XE2%X80?CoV%XE2%X80?2 IgM assay may occur due to cross%XE2%X80?reactivity from pre%XE2%X80?existing antibodies or other possible causes; due to the risk of false positive results, confirmation of positive results should be considered using a second different assay
- QC1: Negative: TRIS buffer, defibrinated human plasma negative for anti-SARS-CoV-2, surfactant, protein (bovine), < 0.1% sodium azide and 0.5% ProClin* 300
- QC2: Positive: TRIS buffer, defibrinated human plasma, human IgM conjugated to anti-SARS-CoV-2 antibodies, surfactant, protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300
- 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner