NG Test IgM and IgG Cassette – COVID-19 RAPID TEST

INSTRUCTIONS AND INTERPRETATION OF THE RESULTS

Carefully read the instruction leaflet before performing the test.

VIDEO

PERFORMANCE OF THE TEST

The overall specificity of the test NG•TEST® lgG-lgM COVID-19 was evaluated on a panel of 406 negative samples (55 sera, 13 heparinized plasmas, 10 citrated plasmas, 279 EDTA plasmas and 49 whole blood samples). The results are presented in the following table:

The overall sensitivity of the test was evaluated on a panel of 100 positive samples from hospitalized patients confirmed by RT-PCR. The results are presented in the following table :

CONTENTS OF THE KIT

FORMAT/KIT: kit of 20 tests

Each kit contains:

20 cassettes individually packaged in aluminium pouches with desiccant
20 calibrated micropipettes to deliver up to 10 µL blood
20 lancets (for finger prick)
20 sterile alcohol wipes
1 buffer solution in a plastic dropper bottle
1 instruction leaflet

INSTRUCTIONS AND INTERPRETATION OF THE RESULTS

Carefully read the instruction leaflet before performing the test.

VIDEO

PERFORMANCES

NG•TEST® lgG-lgM COVID-19 was assessed by Bicêtre Hospital (bacteriology and hygiene department) and Paul Brousse Hospital (virology department), AP-HP. Paris Saclay, University, France. The test results were compared with the results obtained with the standard method (RT-PCR).

Reference :
Dortet Laurent et al. Rapid Determination of SARS-CoV-2 Antibodies Using a Bedside, Point-of-Care, Serological Test; Lancet 2020; 20 April 2020. Preprint DOI : http://dx.doi.org/10.2139/ssrn.3582814

CONTENTS OF THE KIT

FORMAT/KIT: 20 CASSETTES INDIVIDUALLY PACKAGED IN ALUMINIUM POUCHES

Each kit contains:

20 cassettes individually packaged in aluminium pouches with desiccant
20 calibrated micropipettes to deliver up to 10 µL blood
20 lancets (for finger prick)
20 sterile alcohol wipes
1 buffer solution in a plastic dropper bottle
1 instruction leaflet