COVID-19 – IgM-IgG Rapid Test Rapid IgM-IgG combined antibody test for SARS-CoV-2The BioMedomics Rapid IgM-IgG combined antibody test for COVID-19 distributed by BD is a visually read lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies directed against the novel SARS-CoV-2 in human finger-stick (capillary) or venous whole blood, serum, and plasma samples.

525 cases were tested: 397 (positive) clinically confirmed (including PCR-confirmed cases) SARS-CoV-2-infected patients and 128 non-SARS-CoV-2-infected patients (128 negative).

Of the 397 blood sample from SARS-CoV-2-infected patients, 352 tested positive for at least one of the antibodies, twelve of the blood samples from the 128 non-SARS-CoV-2 infection patients tested positive.1

This test is distributed by BD for BioMedomics

Simple testing process• Works with whole blood, serum and plasma

• Visually read lateral flow immunoassay

• Compatible with the following anticoagulants (EDTA, heparin and sodium citrate)

Assay performance

Using finger-stick capillary blood

Using venous whole blood, serum, or plasma from a tube

COVID-19 – IgM-IgG Rapid Test New rapid test to detect evidence of present or past exposure in 10-15 minutes. Detection of COVID-19 IgM antibodies may indicate a recent exposure, whereas detection of COVID-19 IgG antibodies may indicate a later stage infection.1

2 3 41

BD, Sparks, MD, 21152 800.638.8663BD, the BD Logo and Microtainer are trademarks of Becton, Dickinson and Company. All other trademarks are the property of their respective owners. © 2020 BD. All rights reserved. 447-US-0320 April 2020

Ordering Information Cat. No. Quantity

COVID-19 – IgM-IgG Rapid Test 256083 20 tests

Other Essential Products Cat. No. Quantity

BD Microtainer® Contact-Activated Pink Lancet MEDIUM FLOW – 21-Gauge (1.8 mm)

366593 200 units

BD Microtainer® Contact-Activated Blue Lancet HIGH FLOW – Blade (2.0 mm x 1.5 mm)

366594 200 units

Reference: 1. Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S et al, Development and Clinical Application of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis. J Med Virol. 2020. Accepted Author Manuscript. doi:10.1002/jmv.25727

bd.com/COVID-19

Sensitivity 89%

Specificity 91%

CGM

CGM

C G M

2 3 41

This test has not been reviewed by the FDA.

• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.

• Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

One test kit contains:

• 20 Test Cassettes

• 1 Buffer Solution Bottle

• 1 Package Insert