In recent weeks, politicians have started selling the public promises of rapid coronavirus tests that could provide answers within 15 or 30 minutes. The prevailing belief is that by routine daily testing of large numbers of people, the epidemic can be blocked, thereby opening up the economy again.
After Prime Minister Benjamin Netanyahu and Deputy Health Minister Yoav Kish (Likud) started promoting the Sofia device for conducting rapid tests, Defense Minister Benny Gantz and Science and Technology Minister Yizhar Shai came out boasting about purchasing test kits made by the American company Visby Medical.
The state’s decision to purchase rapid testing kits raises some troubling questions. It’s unclear to what extent this decision relies on recommendations by experts. Thus, for example, experts in both Israel and other countries are divided on the issue of the true efficacy of these kits in mass screenings, such as in schools or workplaces, since the tests are not considered accurate enough, as well as having a low throughput. Furthermore, a medical team is usually required for operating these kits.
One expert has warned that there is political pressure to promote rapid testing without sufficient medical or professional evidence to back up its value. “Gantz saw that Bibi was promoting the Sofia kits so he chose Visby,” the expert said. While politicians are vigorously pushing the purchase of rapid testing kits that have questionable effectiveness, more promising methods such as pooling, which can dramatically increase the number of tests performed, are being held up for months by the Health Ministry.
The Defense Ministry has recently announced the purchase of 300 Visby Medical kits, capable of yielding results within 23 minutes. Visby, a company headed by Israeli entrepreneur Adam de la Zerda, has developed technology that miniaturized and speeds up the older PCR method. The technology is new, and was given emergency approval by the U.S. Food and Drug Administration.
PCR, or polymerase chain reaction, rapidly replicates DNA or RNA and is considered an accurate diagnostic tool used in labs for infectious diseases. Traditionally, PCR testing uses a machine the size of a large microwave and can cost hundreds of thousands of dollars. Visby shrinks that machine to a portable palm size, thereby making the process scalable.
“This is really good news which will help us cut the chain of infection quickly and effectively. We’ll be able to quickly test medical teams on a daily basis, as well as people living in assisted living facilities. We’ll be able to deal with concerns about outbreaks in schools, essential workplaces and more,” wrote Gantz.
However, it’s not certain that the product can fulfill Gantz’s promises. First of all, Visby is a start-up company with limited production capabilities. In order to carry out large-scale testing, tens or hundreds of thousands of tests a day are required. De la Zerda himself admitted in an interview last Friday that the number of orders exceeds what his company can supply. “We can currently produce tens of thousands of kits a month, hoping to reach hundreds of thousands,” he said.
In addition to the rate of production, the price of each kit has yet to be determined. Each kit is a small, disposable one, with an estimated price of several tens of dollars. At this price, massive testing in factories and schools could be very costly. The accuracy of these tests has also not been published yet. If the sensitivity of these tests is too low, Health Ministry guidelines will require further PCR tests for anyone having a negative result. This will make the process more expensive and cumbersome.
Questions around the choice of Visby are put into sharper focus given the available alternatives around the world. For example, the U.S. has already purchased 150 million kits made by Abbot, which yield results in 15 minutes at a cost of $5 per kit.
So why was Visby chosen? Did the decision to buy this particular product come after an extensive professional examination and after consultation with experts? That’s not clear. This move was made after Shai, a former venture capital investor, turned to Ittai Harel, managing general partner at Pitango Venture Capital, asking him to help locate technologies for combating the virus. Harel, an investor and member of the board of directors at Visby, suggested Visby. Shai then brought the idea to his party leader, Defense Minister Gantz, and the ministry spearheaded the purchase venture.
The Defense Ministry had this to say on the matter: “The Defense Ministry, through its office in Washington, purchased an initial amount of 300 kits from Visby Medical, in order to test the sensitivity, specificity and reliability of this technology. The tests are done in coordination with the Health Ministry, as part of an effort to find and examine new technologies for rapid testing of COVID-19 patients, in Israel and around the world.
“Priority is given to methods already tested by other standardization institutions. When laboratory testing of these kits is completed, the way in which new technologies can be blended into the national diagnostic apparatus will be examined, in coordination with the Health Ministry. This will take into account economic aspects, convenience of use and the way these fit in with different sectors of the economy.”
Risking false negatives
On the other side of the government’s political spectrum, Netanyahu and Kish were proudly presenting the Sofia device, purchased by the Health Ministry. These kits test for antigens, giving results in only 15 minutes. The Prime Minister even posted a video of himself taking the test with the new kit. Israel purchased 200 devices and 300,000 test kits, costing the state tens of millions of shekels. Health maintenance organizations and hospitals have already equipped themselves with these kits.
In this case too, it seems that the enthusiasm was premature. The sensitivity of Sofia in symptomatic cases stands at only 84 percent. This entails a high risk of false negative results. Thus, the Health Ministry has told HMOs, to their dismay, to test only people with symptoms, and that when results are negative, to carry out PCR tests as well.
Esther Admon, the head of the laboratory workers union, welcomed the idea of rapid testing, but hurried to state her reservations regarding the Sofia devices. “The joy is premature, since this device is still in the phase of early testing. There are already problems with operating it and in ensuring high-quality testing” she said.
“The correct use of this device is unsuitable for nursing or medical staff, who are busy with many other tasks,” adds.
Another logistical problem, it turns out, is that the device does not interface well with existing computer systems. “This is a pitfall that can lead to confusion and loss of data,” she said.
In the meantime, the Health Ministry is getting ready to publish a bid for the acquisition of additional rapid test methods. Overseas, there are also fierce arguments regarding the efficacy of rapid tests. These could be very useful in specific cases, such as emergency wards. But speed comes at the expense of output, sensitivity and availability. Many tests require doctors to administer them, making them infeasible in schools or places of work. “One should not plan based on wishful dreams,” warns one expert.
A report published last week by the national center for information on the campaign against coronavirus, prepared by biologists and military intelligence officers, raises similar points. It suggests that it would be better not to rely on rapid tests, proposing instead that changes be made and technological improvements introduced in the existing testing apparatus, which is based on PCR testing in labs.
“The key to increasing output lies in point changes to the current system” says the report. “This will allow a substantial expansion in the amount of testing done, as well as reducing costs. In order to obtain significantly greater efficiency, it is recommended to promote a national plan for incorporating improvements to the current system.”
Among the methods mentioned is the pooling of samples, which enables the testing of many samples simultaneously; self-testing using saliva instead of the swabs currently in use; methods that neutralize the virus during sampling, which saves precious time in the lab, and other tests that don’t rely on extracting RNA (namely, direct PCR), and more. The report says that introducing these methods will allow testing hundreds of thousands of people within just a few weeks, with results obtained within hours and without significant increase in costs.
The problem is that embracing these recommendations requires quick and flexible action by the Health Ministry, and a willingness to quickly adopt new technologies. But during this crisis, it has been shown time and again that this ministry does not exactly excel in these qualities. Thus, for example, the ministry has been studying pooling methods for six months, without yet giving them final approval.
The Health Ministry said it is working to validate the results given by the Sofia device and said the results “would be published by the head of the public health service. In addition, a specific memo regarding the usage of rapid testing devices outside of medical labs was published. The Visby technology requires the same validation processes that any new technology requires. The Health Ministry is religiously examining the possibility of pooling tests and is also now working to validate them as well. These results will also be published in the future.”