Nadal® COVID-19 IgG/IgM Rapid Cassette Test Kits (BNCP-402 and BNCP-402S)

The NADAL® COVID-19 IgG/IgM Test is a lateral flow chromatographic immunoassay for the qualitative detection of anti-SARS-CoV-2 IgG and IgM in human whole blood, serum or plasma specimens of symptomatic patients.

Note that in the early stages of infection (3 to 7 days after the onset of symptoms) anti-SARS-CoV-2 IgG and IgM may be below the detection limit of the test. This test is intended for use as an aid in the diagnosis of primary and possible secondary SARS-CoV-2 infections. The test procedure is not automated and requires no special training or qualification. The NADAL® COVID-19 IgG/IgM Test is designed for professional use only.

Nadal external clinical studies have shown that the test kit’s obtained the following results;
The test kits include 25 test’s per box, 2 buffer solutions, instructions and 30 x 20uL pipettes

1. a. High sensitivity with 93,7 % (IgM) and 98,8 % (IgG)
2. b. High specificity with 99,1 % (IgM) and 98,7 % (IgG)
3. c. CE marked for professional use and is therefore a registered IVD device
4. d. Results Within 10 Minutes
5. e. EC Approved
6. f. Screen anywhere, anytime
7. g. Qualitative detection of SARS-CoV-2 antibodies (IgM and IgG)

Nadal’s quality management system has been EN ISO 13485 and ISO 9001 certified since 2003, and is reviewed by TÜV Rheinland on a yearly basis. Internal audits, an extensive process map and corrective- and-preventative system help us to maintain the highest standards. Nadal’s products, in line with European IVD-directives, are CE certified and have proven their capabilities on the market over many years. We take part in proficiency tests regularly and with great success.