Setting aside the politics of a particular government’s approach to handling the coronavirus crisis, most of us want to know the current state of play with COVID-19 testing, both for active coronavirus infection and antibody immunity acquired. Also, we know vaccines are not yet available but what is the status of the various therapeutics (drugs to slow or push back coronavirus spread, once infected)?
I’ve tried to be as concise as possible going over the details of coronavirus/COVID-19 testing and therapeutics. Please bear in mind this is information accurate as of 7th April 2020.
How Do We Test for Covid-19?
There are currently two ways to test for Covid-19:
- Antigen testing, to see if someone currently has the virus
- Antibody testing, to see if somebody has had the virus
At the moment most focus is on antigen testing, mainly for critical-care patients and frontline health-care workers, to detect if they currently have the virus.
Antibody tests exist commercially but none, as yet, have been validated except in a handful of individual countries via emergency (speculative) approval.
This is currently a PCR test that involves extracting ribonucleic acid (RNA) from the back of the nose, or via a throat swab, and then converting it into DNA.
This is then replicated many times so that a significant quantity of the DNA can be detected by a PCR machine.
Detection indicates whether the virus is present in a patient’s system.
Lab-based antigen tests are generally taking around 24 hours to process. The government has made excellent strides in reducing these times, including partnerships with logistics companies, drive-through testing facilities and the building of “super labs” across the country.
A critical element to mass testing will be driving and scaling innovations in rapid antigen testing and tests that can be delivered at the point of care.
The antibody (or serological) test involves taking a blood sample and looking at whether immunity has been developed by the presence of antibodies in the blood – in this case the Covid-19 IgG antibody, which develops around two weeks after the infection.
Covid-19 antigens are placed on the surface of a microtiter plate. Patient serum is then incubated in each well and the IgG antibody from the patient is detected using a secondary antibody that binds to human IgG. If the patient has antibodies to the Covid-19 antigen, this patient will be called seropositive for the Covid-19 antigen. This process is typically done via a finger-prick blood test.
Acting very much like a pregnancy test, with lines that appear to show the result, this test offers three interesting signals:
- A solitary positive for IgM means the person has had a very recent (potentially current) infection.
- Positives for both IgM and IgG mean the user was infected some time within the past month.
- A positive for IgG alone means that the infection occurred more than a month ago and the user should now be immune to a repeat of it.
A negative result probably means no infection, though it could also mean that it is too early in the course of an infection for antibodies to have appeared, since the first IgMs typically turn up only 7 to 10 days after an infection has begun. This is why PCR testing will remain important.
Note on Immunity
There is a consensus in the scientific community that some immunity is conferred once a patient has had Covid-19. A report from the European Centre for Disease Control and Prevention on 25 March says, “there is emerging evidence from early studies suggesting that individuals develop antibodies after infection and are likely to be immune from reinfection in the short term”.
Rapid Tests That Have Passed FDA/EUA/China Regulatory Systems
|Developer||Test||Description||Regulatory Mark Received|
|Bodysphere||Antibody: Lateral flow chromatographic immunoassay to detect antibodies||Two-minute testing kit for diagnosing Covid-19||FDA Emergency Use Authorization (EUA)|
|Abbott||Abbott ID NOW COVID-19||POC PCR isothermal test that delivers a positive result in five minutes and a negative result in 13 minutes||FDA EUA approval|
|Guangzhou Wondfo Biotech (Guangzhou, China)||Wondfo SARS-CoV-2 antibody test||Lateral flow 15-minute immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2||National Medical Products Administration EUA in China; CE mark in Europe|
|Innovita Biological Technology||SARS-CoV-2 antibody assay||Lateral flow 15-minute immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2||National Medical Products Administration EUA in China|
|Jiangsu Medomics Medical Technologies (Nanjing, China)||SARS-CoV-2 rapid combined IgM/IgG antibody test kit||Lateral flow 15-minute immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2||Shipping|
|Mammoth Biosciences||SARS-CoV-2 DETECTR||30-minute lateral flow assay||In validation studies|
|Pharmact (Berlin)||SARS-COV-2 Rapid Test||POC 20-minute test for detecting SARS-CoV-2 exposure through identification of IgG and IgM antibodies||CE-marked and shipping|
|Snibe Diagnostic (Shenzhen, China)||MAGLUMI 2019-nCoV IgM/IgG kit||Automated central laboratory rapid test that runs on MAGLUMI chemiluminescence immunoassay system||CE mark received 19 February 2020|
|Sona Nanotech (Halifax, Nova Scotia)||Rapid SARS-CoV-2 antigen detection test||Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein||Assay development and testing with GE Healthcare Life Sciences underway|
|Sherlock Biosciences, Cepheid||Rapid CRISPR-based tests for SARS-CoV-2 and other pathogens||Combines SHERLOCK Cas12 and Cas13 enzymes for nucleic acid detection with Cepheid’s GeneXpert test-processing instruments||Intended as proof of concept for a broad product development alliance in infectious disease|
|Zhejiang Orient Gene Biotech (Zhejiang, China)||COVID-19 IgG/IgM Rapid Test||Solid-phase immunochromatographic assay||Aytu Bioscience has sublicensed US distribution rights from L.B. Resources (Hong Kong) and plans to obtain EUA; already has CE mark|
|Biomerica||Rapid POC IgM/IgG antibody test||$10 lateral flow immunoassay||Commenced shipping samples; seeking FDA EUA approval|
|Caspr Biotech||Ultrasensitive, rapid, and portable coronavirus SARS-CoV-2 sequence detection||Based on CRISPR-Cas12||Proof of principle evaluation|
|Sugentech (Daejeon, South Korea)||SGTi-flex COVID-19 IgM/IgG||Ten-minute lateral flow immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2||CE Mark|
|Cepheid||Xpert Xpress SARS-CoV-2||Rapid PCR test that runs on GenXpert benchtop system – delivers result in two hours from sample collection to delivery of result||Received FDA EUA|
|Xiamen AmonMed Biotechnology (Fujian, China)||COVID-19 IgM/IgG test kit (Colloidal gold)||Ten-minute lateral flow immunoassay that detects IgM and IgG antibodies directed against SARS-CoV-2||CE mark|
|RayBiotech||Coronavirus (COVID-19) IgM/IgG Rapid Test Kit||Suitable for the qualitative detection of coronavirus (SARS-CoV-2 / COVID-19) N-Protein IgM / IgG antibodies in human serum, plasma, whole blood, or finger prick samples.||FDA EUA|
|ERA-BIO (Era Biology Group)||CE-Marked COVID-19 IgM/IgG Lateral-Flow Kit||A 10-minute sample-to-result lateral-flow assay, which has 95% sensitivity and specificity for the primary and secondary antibodies produced in serum for SARS-CoV-2||CE mark|
In medicine, the branch that deals specifically with the treatment of disease and the art and science of healing. In pharmacology, therapeutics accordingly refers to the use of drugs and the method of their administration in the treatment of disease. The word comes from the Greek “therapeia” meaning “a service, an attendance” the related verb being “therapeuo” meaning “I wait upon.”
COVID-19 has no vaccine and no 100% effective therapeutics available at present (5th April 2020). Vaccines are in development, some at the point of clinical trials, and there are various therapeutics being trialed or approved. These therapeutics have yet to be proven but all have shown some signs of helping the body fight back against the coronavirus spread.
Therapeutics Currently In Trial or Approved
|Favilavi||The first approved coronavirus drug in China has reportedly shown efficacy in treating Covid-19 safely in a clinical trial involving 70 patients.|
|Gilead’s Remdesivir (GS-5734)||An experimental broad spectrum anti-viral that was originally designed to treat Ebola; it has undergone clinical trials in China. The trials are being performed on 761 patients in a randomised, placebo-controlled, double-blind study at multiple hospitals in Wuhan. The results from the trials are expected to be available over the next few weeks.|
|Roche’s Actemra||Approved in China for the treatment of severe complications related to coronavirus, the drug is being evaluated in a clinical trial in China, which is expected to enrol 188 coronavirus patients. The clinical trial is expected to be conducted until 10 May.|
|Chloroquine and Hydroxychloroquine||These drugs have been shown to be safe and efficacious against malaria for decades. Coronavirus patients administered with the Chloroquine Phosphate drug achieved a better drop in fever and shorter recovery time in clinical trials being conducted in Chinese hospitals. Large-scale clinical trials with both these drug are taking place in April.|
|Baricitinib||Artificial intelligence is providing answers. BenevolentAI provides a large repository of structured medical information, including numerous connections extracted from scientific literature by machine learning. Together with customisations bespoke to 2019-nCoV, a team used BenevolentAI to search for approved drugs that could help, focusing on those that might block the viral infection process. This process identified baricitinib, which is predicted to reduce the ability of the virus to infect lung cells.|
Global Companies Testing for International Provision
Lab-Based PCR Testing:
US-based provisioner of scientific instrumentation, reagents, software and services.
Capacity: They are producing PCR swab kits, scaling to 5 million per week. And assisting the UK with ramping up capacity for PCR test with their PCR testing machines.
Swiss multinational health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. They also produce PCR test kits and the testing machines.
Capacity: Their CEO said on 23 March that they had provided 400,000 kits in the US over the last week alone.
British firm Mologic is working with partners in Africa to develop tests that will be manufactured in Senegal.
Capacity: It has been granted £1 million to produce two different types of test by the UK government: one antigen, one antibody.
Northern Irish biotech company Biopanda produces a rapid antibody test.
Capacity: The company is selling its testing privately within the UK and has also previously despatched orders “throughout Europe and across the world.”
SureScreen is a private firm based in Derby, England. They say they have created a test (Rapid Test Cassette) that can determine with 98 per cent accuracy if a person is infected. It involves taking a blood sample via a finger prick and using a screening device. They say diagnostic time is ten minutes.
Capacity: SureScreen says its test has been validated and is already being used by private buyers in the UK, Ireland, Germany, Spain, Switzerland, the Netherlands, Turkey, UAE, Kuwait and Oman. It is believed around 175,000 tests have been conducted with the SureScreen kit so far. The company claims it has had more than 2 million orders for next month.
Northern Ireland-based company Randox Laboratories has also developed a “multiplex viral respiratory infection array” that tests for Covid-19 and nine other infections simultaneously. Randox said the test is capable of processing 324 patient samples, generating 3,240 reportable results, in just eight hours.
Capacity: The company is distributing the tests to more than 40 countries worldwide.
This company is working on a rapid-test PCR kit, which works through a nose or throat swab. It produces a result in two hours.
Capacity: The company says it has enough raw materials to manufacture 3.5 million PCR tests that can provide results in a couple of hours. The company says it has made almost £18 million selling test equipment to more than 80 countries.
- Quadram Institute
Quadram Institute, based in Norwich, England has produced a kit that works from a throat swab sample and is a molecular test to establish if a person currently has Covid-19 (a rapid-test PCR kit). The company says the test could be used in a hospital anteroom, processing 16 samples at a time and displaying the result on a smartphone.
Capacity: We believe it is a small-scale trial at present.
Where Is Antibody Testing Already Being Used?
The US regulatory body the Food and Drug Administration (FDA) has authorised – on an emergency basis – the use of the first antibody test, produced by Cellex. The FDA said it is “reasonable” to believe the testing kit works effectively.
In authorising the Cellex test, the FDA said that “the known and potential benefits of your product when used for diagnosing Covid-19, outweigh the known and potential risks of your product.”
China has approved eight antibody tests, while kits have also been approved in countries like Singapore, South Korea and Australia.
In Europe, it is understood that Germany will be launching a mass antibody testing regime in the coming weeks.