CoNAb™ SARS-CoV-2 Neutralizing Antibody POC Test Kit

A rapid point of care test for qualitative assessment of neutralizing antibodies to SARS-CoV-2 (virus responsible for COVID-19) in human blood from fingerstick, plasma, or serum is available for research use only.

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CoNAb POC Lateral Flow Test Strip

How It Works

The CoNAb Test Kit is a lateral flow test intended for qualitative detection of neutralizing antibodies (NAb) to SARS-CoV-2 in blood, plasma, or serum.

This test assays for the inhibition of the SARS-CoV-2 spike protein S1 subunit—which is conjugated to a sensitive tag and gold nanoparticles (GNP) using our proprietary technology—binding to the ACE receptor.

Results available in just 15 minutes.

Convenient All-in-one Kit

The CoNAb Test Kit contains the following items, making sample collection and testing both simple and convenient:

  • CoNAb Lateral Flow Test Device (1), sample buffer (0.3ml) micro dispenser (1), spring loaded lancet (1), capillary blood transfer pipet (20μl) (1), alcohol pad (1), desiccant bag (1g) (1), Instruction for Use document (1)

Easy Interpretation

The CoNAb Test Kit provides a reference of the amount of NAb present at 1:10 dilution in fingertip blood (equivalent to 1:20 diluted serum or plasma). Featuring a user-friendly design that presents a built-in Control (C) line as well as a Test (T) line indicating the level of NAb inhibition in your sample.

Test (T) Line Shows Relative Inhibition of Individual’s Neutralizing Antibodies

Performance results of CoNAb Test Kit

Reliable Performance

In our clinic study using a total of 157 human blood samples, CoNAb shown 92.86% (95% cl: 84.34% – 96.91%) of sensitivity (Positive percent agreement with EDA FDA registered ELISA comparison product)  and 98.95% (95% cl: 93.77% – 99.94%) specificity (Negative percent agreement with EDA FDA registered comparator).

Practical Interpretation

50% inhibition by CoNAb is approximately equivalent to 1:100 NAb titer by the Comparator, a test that as been  approved by FDA under EUA. A 1:100 average NAb titer is  from convalescent patients.

The display range of 50% to 100% inhibition by CoNAb has been estimated to equal to NAb titer range 1:100 to 1:700 by a comparative ELISA method.

Performance results of CoNAb Test Kit

Why a Neutralizing Antibody Test?

“We’re excited to offer this new test for SARS-CoV-2 neutralizing antibodies that we envision providing critical information to aid individuals to have confidence returning to work or planning travels, in screening plasma donors, and to help evaluate the effectiveness of COVID-19 vaccines and individuals who have convalesced from the virus.”

Jin Wu, Ph.D., Vice President of Innovation, Novodiax

Reference Publications

  • Wang J et al. Rapid lateral flow tests for the detection of SARS-CoV-2 neutralizing antibodies, Expert Rev Mol Diagn. 2021: 1-8,  doi 10.1080/14737159.2021.1913123
  • Lau, E. H. al. Neutralizing antibody titres in SARS-CoV-2 infections. Nature Communications12, 63, doi:10.1038/s41467-020-20247-4 (2021).
  • Mulligan, M. al.PhaseI/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature586, 589-593, doi:10.1038/s41586-020-2639-4 (2020).
  • Jackson, L. al.An mRNA Vaccine against SARS-CoV-2 —Preliminary Report. New England Journal of Medicine383, 1920-1931, doi:10.1056/NEJMoa2022483 (2020).
  • Zhang N et al. A lateral flow test detecting SARS-CoV-2 neutralizing antibodies, ,, Nov 2020. 

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