ARLINGTON, VA., MARCH 20, 2020
Demand for testing has gone from a healthcare industry topic to a national crusade in weeks with the onset of COVID-19. High-throughput tests have been approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. for the detection of SARS-CoV-2, the virus behind the disease. But for true intervention in doctors offices — or even airports, many see so-called “point-of-care” (POC) IVD tests as the ideal solution.
A new report on worldwide point-of-care markets from IVD market researcher Kalorama Information has been released amid the coronavirus outbreak. The report has markets for all kinds of near-patient testing — everything from self-testing for glucose to rapid HIV tests to cardiac marker tests. Yet the focus in recent weeks has been on tests for COVID-19. Point-of-care tests are tests designed to be portable enough and fast enough to be useful during an office visit or in a decentralized location within a hospital or clinic.
“To break a transmission chain, fast access is needed. These tools offer a tool for action, rather than waiting on texts and doctor’s office staff,” said Bruce Carlson, publisher of Kalorama Information.
Kalorama publishes a report each year on POC markets and has just released its 2020 version: https://kaloramainformation.com/product/the-worldwide-market-for-point-of-care-poc-diagnostics-7th-edition/.
In terms of actual tests for coronavirus tests, there are no U.S. approvals at the time of writing, but products are in development. Molecular POC (mPOC) tests make the most sense because the threat is a virus and can be identified using the gold standard of reverse transcription polymerase chain reaction (RT-PCR). Point-of-care tests are currently used for flu and step tests, including systems by Abbott (ID NOW), Roche (Liat), and Cepheid (Xpert Xpress).
mPOC-maker Cepheid says it is developing an automated molecular test for the qualitative detection of SARS-CoV-2. And Cepheid says it will try to utilize its tens of thousands of existing instrument placements. “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and future pandemic coronavirus strains, we are developing a test that can be applied in multiple settings where actionable patient management information is needed quickly,” the company said.
Singapore POC maker Credo Diagnostics Biomedical announced this week that it has obtained the CE mark in Europe for an assay to detect SARS-CoV-2. The test runs on the firm’s platform, called VitaPCR, and the company said it uses PCR and runs the test in 20 minutes. The system needs minimal operator training to run and involves no additional equipment, according to Credo. The company says the VitaPCR SARS-CoV-2 Assay is now also pending Emergency Use Authorization from the FDA and Emergency Use Listing from the World Health Organization.
While not as fast as immunoassays, the mPOC systems typically use isothermal amplification to achieve much faster turnaround than the regular lab-based RT-PCR tests. This is one of their biggest strengths, along with low system cost and portability; however, these can often have a several-fold higher cost per sample compared with RT-PCR performed in a centralized lab due to the small proprietary systems requiring specific cartridges and consumables. The following are some additional examples of molecular diagnostic systems and assays including POC and other technologies which are available or under development:
- Aldatu Biosciences – PANDAA qDx SARS-CoV-2
- Becton Dickinson (BD) – BD and BioGX submitted for EUAs on BD Max platform- BGI/ Pathomics Health – Fluorescent RT-PCR kit (CE marked); 2019-nCoV PMseq Kit
- Bio-Rad – standards – synthetic COVID-19 RNA transcripts and human genomic DNA
- bioMerieux/ BioFire Defense – FilmArray, BioFire COVID-19 Test
- Biomeme – Go Strips for COVID-19
- BIONEER Corporation – AccuPower 2019-nCoV
- Caspr Biotech – Phantom 1.0 Dx, disposable test usingCRISPR
- Cepheid – Test in development for Xpert Xpress system announced; partnership for Sherlock Biosciences’ CRISPR-based SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) engineering biology platform, to design tests to run on Cepheid’s GeneXpert systems
- CerTest Biotec – VIASURE 2019-nCoV Real Time PCR Kit (CE mark for BD Max platform)
- Co-Diagnostics – Logix Smart Coronavirus Disease 2019 (COVID-19) Test; single step rRT-PCR (CE mark)
- Coyote Bioscience – Mini8 Portable Molecular Diagnostic QPCR Station (CFDA approved)
- Credo Diagnostics Biomedical – VitaPCR platform, COVID-19 assay (CE mark)
- Curetis/ OpGen/ BGI – RTPCR test kit for SARS-CoV2 (CE mark)
- Diagnostics for the Real World Ltd – SAMBA II COVID-19 Test
- GenMark – ePlex SARS-CoV-2 test; sample-to-answer system based on competitive DNA hybridization and electrochemical detection technology (RUO, with EUA submitted)
- HiberGene – HG Swift, can use battery power, pursuing Fast Track Emergency Use in China
- Integrated DNA Technologies (Danaher) – 2019-nCoV CDC EUA Kit
- Jiangsu Qitian Gene Biotechnology Co., Ltd. – Fluorescent RAA Detection for 2019-nCoV
- LabCorp – COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test (EUA issued)
- LGC Biosearch – primer and probe kits for CDC Real-Time RT-PCR Diagnostic Panel
- MiCo Biomed Co. Ltd – VERI-QTM PCR 316 COVID-19 detection system
- Mobidiag – Novodiag COVID-19 + InfA/B – multiplex test for coronavirus and influenza
- Molbio – TrueLab, Truenat SARS CoV-2 – TruePrep and TrueNAT instruments
- Mologic – battery powered point-of-need diagnostic test
- Novacyt – qPCR (CE mark)
- OnSiteGene – Peak V
- Pinpoint Science – SARS-Cov-2 test in partnership with Analog Devices
- Qiagen – QIAstat-Dx, Respiratory Panel 2019-nCoV
- QuantuMDx – Q-POC
- RainSure Bio – DropX-2000 Digital PCR System, RainSure COVID-19 dPCR Detection Kit
- Randox Laboratories Ltd – Extended Coronavirus Array
- Seegene – Allplex 2019-nCoV assay (CE mark)
- Sentinel Diagnostics – Stat-NAT COVID-19 assay
- SolGent – DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit (CE mark)
- Twist Bioscience – NGS-based target capture for SARS-CoV-2 detection and screening
- Ubiquitome – Liberty16, open mobile real time PCR system with 2-3 hour battery life
In addition to direct tests for SARS-CoV-2, Kalorama expects demand for flu tests to increase due to “rule-out” testing.
Right now, molecular is the focus for the current pandemic, but immunoassays also are in development. Molecular tests generally analyze the viral RNA in patient throat/nasal swabs, but there are other POC testing methods that use immunoassays to detect the patient’s COVID-19 antibodies in blood or serum. It appears there are roles for both mPOC and immunoassay POC tests as there are trade-offs between the two. Immunoassays generally suffer from a high rate of false negatives (low sensitivity), with some rare exceptions.
Nonetheless, immunoassays can have comparable specificity and a varying combination of lower cost, faster turnaround, greater portability, and, thus, advantages in the context of larger-scale population surveillance, screening, and triaging of patients in outbreak situations.