COVID-19 Testing
At The Point of Need

Rapid and reliable testing is fundamental to managing COVID-19 in individuals and populations, and is key to getting stalled economies moving again.1,2

dianax is on a mission to create a step change in COVID-19 diagnostics by allowing clinical tests to happen ANYWHERE, ANYTIME and for ANYONE.

**AVAILABLE NOW**

The COVID19SEROSpeed-IgM-IgG Rapid Test is a reliable COVID-19 antibody test for use at the point of need.

COMING SOON

The dianax COVID KnowNow solution combines the convenience of rapid, reliable antibody testing with the analytical power and connectivity of the dianax COVID-AI platform.

COVID-19 Testing Overview

RT-PCR is the current gold-standard for laboratory diagnosis of COVID-19.1,2
However, restricted laboratory capacity and the complexities of testing can mean long delays in obtaining results.1 Furthermore, as viral RNA levels usually decline within two weeks of initial infection, delayed sampling can result in negative RT-PCR even in active cases.1,2

 

Theoretical kinetics of appearance of antibodies during infection.5

Serology testing (detection of antibodies in the blood) is a relevant indicator of current and past infections.2-4 Studies of patients with COVID-19 have detected anti-viral antibodies within days of initial infection.1,4 Typically, immunoglobulin (Ig)M is produced as a response to acute infection, with IgG appearing within 1 to 3 weeks to sustain longer-term immunity.1,4

Antibody testing is complementary to RT-PCR in the detection and management of COVID-19.1-5

Uses for rapid antibody testing include:2,3,6

  • Catch-up diagnosis* for suspected COVID-19 cases with missed or delayed RT-PCR
  • Rapid screening for at-risk groups and keyworkers
  • Point of need testing for those with restricted lab access
  • In epidemiological studies for:
    1. Risk stratification
    2. Assessing incidence, severity, and territorial expansion of COVID-19
    3. Evaluating population-level disease control measures

*Negative antibody test result does not exclude COVID-19. Antibody testing should not be used as the sole diagnostic test.5

Currently available** rapid antibody tests for COVID-19 are qualitative – the result is either positive, negative, or indeterminate.2,7 Accurate quantification of specific antibodies in the blood can provide additional valuable information about stage of infection.7

Quantitative antibody tests performed in a laboratory require specialized instruments and take several hours to complete.7 dianax is developing a POINT OF NEED artificial intelligence-driven testing solution that provides semi-quantitative results within 15 minutes without laboratory instruments.

**Statement relates to the availability of lateral flow assays as at 12 June 2020.

COVID19SEROSpeed-IgM-IgG RAPID TEST

dianax has partnered with experts in rapid diagnostic technology and infectious diseases – BioSpeedia (a spin-off of Institut Pasteur) – to bring to market a reliable test for rapid detection and differentiation of IgM and IgG antibodies to novel coronavirus SARS-CoV-2.5

Not all rapid antibody tests are equal – marketed tests vary widely in quality, sensitivity and specificity1,4,6

The COVID19SEROSpeed-IgM-IgG Rapid Test is a lateral flow assay that rapidly and reliably detects antibodies to the S1 spike protein and the nucleocapsid protein of SARS-CoV-2.5

We are in the process of completing a robust clinical evaluation program of the COVID19SEROSpeed-IgM-IgG Rapid Test, in collaboration with several European hospital laboratories. Preliminary results from almost 1,000 patient samples show high specificity for SARS-CoV-2, as well as high sensitivity at 11 days from symptom onset, compared with RT-PCR.8

Our ongoing evaluation of the COVID19SEROSpeed-IgM-IgG Rapid Test will further strengthen results from completed clinical studies that have found:5

***Detection of IgM or IgG in 302 samples taken between 11 and 30 days after symptom onset.5
****In 40 RT-PCR-negative samples taken before 1 January 2020, including 20 subjects with autoimmune diseases, 2 HIV+ serology, 1 Hepatitis B+ serology.5

COVID19SEROSpeed-IgM-IgG Rapid Test is administered at the POINT OF NEED*****, without any requirement for laboratory instruments.5

Individually-packaged test kits are supplied ready to use and can be stored at room temperature.5

Testing can be performed with a simple finger prick, or using serum, plasma or whole blood samples. Results are displayed visually within 15 minutes.5

*****Tests must be performed by a healthcare professional.

Click below to download detailed instructions for use.

COVID-19 TESTING PIPELINE

dianax COVID KnowNow solution aims to take rapid testing to the next level

Pan-European trials are currently evaluating the dianax COVID KnowNow solution: the COVID19SEROSpeed-IgM-IgG Rapid Test in combination with the dianax COVID-AI Platform.******

This artificial intelligence (AI)-based system transforms qualitative results from rapid antibody testing into semi-quantitative estimates of antibody titer, with instant remote connectivity to experts for validation.

******dianax KNOWNOW solution is under development but not yet approved for use. For investigational use only.

When testing for COVID-19, physicians and patients need to KNOW NOW. dianax is on a mission to make this goal a reality.

GLOSSARY

Lateral flow assay: Also known as lateral flow immunochromatographic assays, these rapid tests detect the presence of a target substance in a liquid sample without the need for specialized and costly laboratory instruments.

Positive predictive value:  The probability that following a positive test result, that individual will truly have that specific disease.

RT-PCR: Reverse transcription polymerase chain reaction is the gold standard laboratory test for detecting the presence of viral RNA.

Sensitivity: The proportion of people who test positive among all those who actually have the disease.

Specificity: The proportion of people who test negative among all those who actually do not have that disease.

RESOURCES

REFERENCES:

  1. Lee CY-P, et al. Front Immunol 11:879.
  2. Jacofsky D, et al. J Arthroplasty 2020 https:/doi.org/10.1016/j.arth.2020.04.055.
  3. Foundation for Innovative New Diagnostics (FIND), 2020. https://www.finddx.org/wp-content/uploads/2020/05/FIND_COVID-19_RDTs_18.05.2020.pdf (Accessed June 2020).
  4. Sun B, et al. Emerging Microbes & Infections, 2020:9(1):940-8.
  5. COVID19SEROSpeed-IgM-IgG/BSD_0501 Rapid Test Instructions for use v3.1 2020/06/08.
  6. Tré-Hardy M, et al. J Infection 2020. https://doi.org/10.1016/j.jinf.2020.05.019.
  7. Abassi J. JAMA 2020; 323(19):1881-3.
  8. Data on file available on request.