Emerging Diagnostic Test Products For Novel Coronavirus (COVID-19)

Over the last few months, the coronavirus outbreak has spread to various countries such as China, South Korea, Italy, Iran, Japan, Singapore, Hong Kong, the United States, and other countries. It has endangered thousands of lives in a short span of time. Hence, several diagnostic companies have been focused on the development of promising diagnostic test products to expedite the diagnosis process as quickly as possible to save the lives of people.

The pipeline landscape of the coronavirus detection is robust with the involvement of several diagnostic test products such as PANDAA qDx SARS-CoV-2, RabWiz Ultra-Sensitive COIV-19 Viral Antigen Test Kit (ELISA) & AiroStotleCV19 (Breath VOCs), etc. Below is a list of the company and its product descriptions and key information for all the emerging diagnostic test products

Canary Health Technologies: AiroStotleCV19 (Breath VOCs)

Canary Health Technologies has developed AiroStotleCV19 (Breath VOCs), a highly sensitive, specific, non-invasive and cost-effective test using VOCs analysis as a result of oxidative stress offers a potentially powerful new approach to early diagnosis COVID-19

Aurora Biomed Inc.: SARS-COV-2 Detection Kit

SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation involved in targeting genes includes ORF1ab and N gene and produces 24 tests per kit. It shows a detection limit in 200copies per mL. However, positive and negative test control is also used to monitor the test accuracy.

GNA Biosolutions GmbH: SARS-CoV-2 Detection Kit

GNA Biosolutions GmbH has developed the SARS-CoV-2 Detection Kit on a portable PCA Analyzer which comprised of an instrument and disposable test chips. The test would run on the neo system whichamplifies and detects genetic material and can be used to test eight samples at a time. Moreover, it can also provide analysis within 15-25 minutes.

FluroTest LLC: CompleTest Platform Technology

FluroTest LLC uses the CompleTest platform technology to test for a range of viruses including COVID-19, as well as accurately determining the viral load.  Additionally, FluroTest ‘s technology can be adapted to allow for the detection of specific anti-SARS-CoV-2 human antibodies in blood samples, potentially confirming the development of immunity. Once developed, both tests would be administered at point-of-collection with results expected to be available in less than 15 minutes.

Attomarker Ltd: Immuno-Kinetic Assay for Covid-19

Attomarker Ltd has Developed the Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP (automated) which relies on detecting virus RNA in a swab sample from the patient’s throat or nose. It is a Portable device Attomarker Liscar which comprised of 4 bench-top instruments, each providing results in just ten minutes.

Emerging Diagnostic Products Landscape for Novel Coronavirus (COVID-19)

Company Name/ SponsorsProduct Test TypeProduct Description
Academia Sinica  Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kitSimple detection procedure Only 15- 20 minutes
Access Bio Korea, Inc. CareStart COVID-19 IgM/IgGThe device is designed to amplify a total of two unique target genes of SARS-CoV-2 to improved sensitivity and with its high sensitivity
AIVD Biotech Inc. COVID-19 IgG/IgM Rapid Test (colloidal gold-based)OEM onlyResults within 10-15 min
Aldatu Biosciences PANDAA qDx SARS-CoV-2 Real-time PCR detection of COVID-19 Disease
Ativa Medical Ativa Enhanced ScreenMiniaturized low-cost diagnostic testsImmediate lab-quality results
Attomarker Ltd Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP (automated) It relies on detecting virus RNA in a swab sample from the patient’s throat or nosePortable Attomarker Liscar  bench-top instrument, each providing results in just ten minute
Aura Biotechnologies Ltd 
Quick COVID-19 Colorimetric LAMP PCRFast and simple yet accurate detection for coronavirusTakes 30 minutes’ assay
Aurora Biomed Inc. SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation Target genes: ORF1ab and N gene200 copies per mL detection limitPositive and negative controls to monitor test accuracy24 tests per kit
Beijing Infervision Technology Co. Ltd InferRead CT PneumoniaCT-AI Based model is efficient and reliable
Canary Health Technologies AiroStotleCV19 (Breath VOCs)A highly sensitive, specific, non-invasive and cost-effective test using VOCs analysis as a result of oxidative stress offers a potentially powerful new approach to early diagnosis COVID-19
DNA Software, Inc. Upper Respiratory Virus Panel, multiplex PCR, COVID-19, Influenza A BAutomated consensus design of multiple variants of DNA or RNA targets
FemtoDx COVID-19 Antibody TestAt Home testThe test will take under 5 minutesEasy to use the device
FemtoDx COVID-19 Rapid Home Nucleic Acid Test At Home testThe test will take under 5 minutesEasy to use the device
FluroTest LLC Complete TestCompleTest platform technology to test for a range of viruses including COVID-19, as well as accurately determining the viral load.
Fluxergy LLCFluxergy Sample-to-Answer SARS-CoV-2 RT-PCRA point-of-use device capable of comprehensive laboratory
testing
Genedrive plc Genedrive 96 SARS-CoV-2 Kit The assay combines Genedrive’s PCR chemistry integrated with Cytiva’s LyoStable stabilization technology.
GNA Biosolutions GmbH SARS-CoV-2 Detection Kit on portable PCA AnalyzerThe system amplifies and detects genetic material and can be used to test eight samples at a timeProvide analysis within 15-25 minutes  
AB Diagnostic Systems GmbH abia SARS-CoV-2 AbThe world’s easiest to use a range of diagnostic kits for HIV, hepatitis A, B, C, D, E infections, SARS-CoV-2 (COVID-19), prenatal diagnostics (TORCH), hormones (thyroid, fertility), tumor markers and moreCompletely recyclable
Abwiz BioRabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA)It can play a critical role in the development of next-generation COVID-19 diagnostic toolsHighly-specific SARS-CoV-2 monoclonal antibodies