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

(Whole/Serum/Plasma)

Clear

Description

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.

Features / Benefits

  • Significant time and cost saving over lab methods
  • Results within 10 minutes
  • Identifies infection even in mild or asymptomatic cases
  • Assists in the control of viral transmission
  • Screen anywhere and everywhere
  • Ideal as a triage and screening tool
  • Accuracy of all tests available >95% (IgM) and >98% (IgG)
  • Stock available for immediate dispatch 24/7

Additional information

Kit Sizes

30 Test, 60 Test, 120 Test, 500 Test, 1000 Test, 2000+ Test

Delivery

24 Hours Delivery in UK

Stock

Up to 14,000 tests available and in stock

Contents

Per 25 Tests (1 Box)
25 Sealed Cassette Tests
1 Buffer Solution Bottles
25 Capillary Tubes/Pipettes
Instructions

【MATERIALS】
Materials Provided
 Test cassettes  Droppers  Package insert  Buffer
 Capillary Tubes

Materials Required But Not Provided
 Alcohol Swab
 Lancets (for fingerstick whole blood only)
 Timer

Storage Info

【PRECAUTIONS】 1. For professional in vitro diagnostic use only. Do not use after expiration date.

2. Do not eat, drink or smoke in the area where the specimens or kits are handled.

3. Do not use test if pouch is damaged.

4. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

5. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

6. Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample size may lead to deviation of results.

7. The used test should be discarded according to local regulations. 8. Humidity and temperature can adversely affect results.

【STORAGE AND STABILITY】 Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

DO NOT FREEZE.

Do not use beyond the expiration date

Contact

sales@ncovtest.co.uk