SARS-CoV-2
Antibody Test
The LumiraDx SARS-CoV-2 Ab Test is a microfluidic immunofluorescence assay for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (capillary fingerstick or venous), plasma or serum for indication of recent or prior infection. Used with the LumiraDx Platform the Test delivers rapid results at the point of care.
Test benefits
The LumiraDx SARS-CoV-2 Ab Test is designed to be used in community care settings to identify individuals with an adaptive immune response to COVID-19, indicating recent or prior infection.
- Easy to implement in point of care settings
- Clinical agreement (direct fingerstick) in samples collected more than 8 days post RT-PCR
- 100% (62/62) positive agreement
- 100% (54/54) negative agreement
- Time to result in 11 minutes
Test procedure
The Instrument and Test Strips are integrated with several quality control checks to ensure the Instrument and Test are functioning correctly for every test run.
The workflow process is comprised of a simple sample collection with a fingerstick lancet followed by step-by-step guidance of the Instrument to report a patient result in 11 minutes from sample application.
Test performance
Fingerstick sample performance
In clinical studies, fingerstick samples showed 100% positive agreement and 100% negative agreement when collected more than 8 days post RT-PCR.
| Positive agreement | Negative agreement | |
|---|---|---|
| Direct fingerstick | 100% (62/62) | 100% (54/54) |
| Fingerstick via transfer tube | 100% (62/62) | 100% (56/56) |
Plasma sample performance
In clinical studies, plasma samples demonstrated an overall 97.2% positive agreement and 100% negative agreement when compared to RT-PCR.
| Positive agreement | ||
|---|---|---|
| Days from RT-PCR to blood collection | Number of sample | Sensitivity RT-PCR comparator |
| ≤ 6 days | 13 | 84.6 % |
| 7-13 days | 7 | 100 % |
| 14-20 days | 6 | 100 % |
| ≥ 21 days | 46 | 100 % |
| Total | 72 | 97.2 % (90.4 % - 99.2 %) |
More information about the LumiraDx SARS-CoV-2 Ab Test
Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets.
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