As the use of the Covid-19 home test increases, so does the concern that most of these test results go unreported, leading to an underestimation of the actual number of Covid-19 cases nationwide. Another reason that the detection is so low, Mokdad said, is that the majority of people infected with the Omicron coronavirus variant have no symptoms, so they do not even know how to get tested.

Why exams are important

Many diseases have low detection rates, Mokdad said, such as the flu. “The difference is that this is a pandemic,” he said. When people hear that there are many cases of Covid-19 in their area, some may become more cautious. This can prevent them from getting sick and not transmitting the virus. Tests can also tell public health professionals what steps they need to take to keep people safe. For example, when Philadelphia recently saw an increase in cases, it reinstated an indoor mask command. “We must always stand in front of it and not just hope it’s gone,” said Mara Aspinal, a testing expert and intern professor at the College of Health Solutions at Arizona State University. Tests are also important at the individual level. It tells people if they should be isolated so as not to make other people sick. It also tells them if they need to look for treatments for Covid-19 that work best when the disease is diagnosed early.

Change model

State health services in Pennsylvania, Ohio and New York say positivity rates are no longer a reliable measure. Nevada has removed case metrics from its data control panel completely. Government officials acknowledge that ubiquitous availability of home trials has led to underreporting of cases of particularly mild to moderate disease, and say it is difficult to quantify the impact of this missing data. However, the New Jersey Department of Health says the unreliability of the data is unlikely to hinder its ability to determine the severity of the pandemic. There are other measurements that can provide a sense of how much disease there is in the community. The U.S. Centers for Disease Control and Prevention has updated its measurements to determine which Covid-19 restrictions may be necessary. Instead of relying on the number of cases, the hospitalizations are heavier. The body also monitors other indicators, such as the levels of the virus detected in the sewage. Cases are a good indicator of growth, but they are not all, said Spencer Fox of the University of Texas’ Covid-19 Modeling Consortium. His model is based on hospital admissions that test for antibody levels in blood samples. Fox says it is the “gold standard” of early assessment, but “it is becoming more and more complicated because the landscape of immunity in the country is changing.” Omicron is highly contagious and re-infections are becoming more common. In general, however, he believes that understanding pandemic case data is not necessarily worse than it used to be – “but things are likely to change”.

Efforts to streamline the delivery of test results at home

States like Tennessee encourage people who use home testing to submit their results to manufacturers so they can be monitored. It is not clear how many people actually do this, but several efforts are being made to better monitor home trials. The Association of Public Health Laboratories is partnering with the NIH under a contract to use the union’s electronic laboratory reporting platform, AIMS, to help streamline the reporting of Covid-19 home test results. This approach is still based on people using home trials to report their results to manufacturers, but Scott Becker, CEO of the Association of Public Health Laboratories, hopes the AIMS system will make it easier for manufacturers to report to public health authorities. The initiative “is in recognition of the fact that this gap exists in the reports,” Becker said. “In terms of public health, this is a kind of data that is missing, if you will, in the test universe,” Becker said of home test results. “This is a somewhat blind spot.” The Association of Public Health Laboratories announced in March that it had been awarded the NIH contract, limited to $ 8.8 million over three years, to work on improving the reporting of out-of-prescription Covid-19 test results to public health officials. The convention uses AIMS to collect data from in-house test manufacturers and then distribute the data to states and jurisdictions. “A home test has a digital tool that comes with it, and we’re trying to create, in essence, a specification that allows data to flow through the node to the places it needs to go for status reporting.” said Becker. “There are states that are interested in receiving this data and this is really about being aware of the situation.” Another platform pushing for greater efficiency is ReportStream, a cloud-based data routing system developed by the US Digital Service in collaboration with the US Centers for Disease Control and Prevention. The US Food and Drug Administration requires home test makers Covid-19 to develop a mobile app or website “to further facilitate individual reporting of results” using in-house testing. “The FDA had asked for digital solutions after the market for reporting, but beyond that, guidance was limited and that meant that when digital solutions were built and these tests were reported, the way the reporting was done was inconsistent. in different formats, and this made data collection poor. It made data analysis very difficult, “said Dr. Krishna Juluru, Presidential Innovation Partner at the National Institute of Biomedical Imaging and Industry, which advises digital health solutions for the RADx initiative. Juluru and his colleagues have worked to “establish standards and common ways of communicating these results.” Platforms such as AIMS and ReportStream, called nodes, serve as destinations where Covid-19 home test results can be sent and then transmitted to public health departments that want the data. An additional copy of the message is sent to a federal system called HHS Protect, creating a unified national view of the Covid-19 test results. At the state level, AIMS is associated with all U.S. states and territories and has long been used to route laboratory test results to government health systems, according to the NIH, and ReportStream is associated with most states. “So it removes that burden from the test builder, from the application developer, from the need to develop direct connections to all states,” said Andrew Weiz, program director at the National Institute of Biomedical Imaging and Industry and co-director. of the RADx Mobile Application Reporting through Standards program, or RADx MARS, with Juluru. Each Covid-19 testing laboratory site is required to report the results of diagnostic tests and screening tests to state or local public health authorities, but individuals performing self-diagnostic tests are not required to report the results. This can lead to many home test results not being reported, resulting in data gaps. “Although it is up to the individual to choose to report, we still hope to address this blind spot,” Juluru said.

“We need to be more strategic”

There are estimates of how many home trials may not be reported. A pre-printed study by researchers at the University of Massachusetts and other US institutions, published this month, suggests that when people use the Covid-19 test at home, only about 8.1% of them will also use the “digital assistant”. »Or the application that is coming. With this. Of those who used the app, however, more than 75% reported their results to state public health authorities. People were less likely to report a positive test result. “Voluntary reporting was low overall, but what we also found was that when people were using a digital solution – when they had access to their digital tool to help guide their testing, to help guide them how to do it – we found that the reference rate was very high, around 75%, “said Juluru. “This is really very encouraging.” The overall low use of the app may be due to a lack of training on the importance of reporting test results, the researchers said. With regard to Covid-19, the number of cases reported in each state will continue to decline and flow, and it will be important to monitor this data and monitor the spread of the disease, Becker said. Jennifer Nuzzo, an epidemiologist and professor at Brown University, believes more needs to be done to monitor the pandemic to make up for the lack of data. “We’re going to see a signal. It will just be harder to interpret and know what to do about it,” said Nuzzo, who is director of the Brown Pandemic Preparedness and Response Center. Opinion polls would help. “We need to be more strategic. You just can’t have more tests at home,” Nuzzo said. “If you go out and deliberately sample in these neighborhoods, we would have a better understanding.” Nuzzo’s main concern is that the country is now at a real disadvantage in understanding how the virus is transmitted. “If people get sick at the grocery store, then you need to know it to encourage people to wear masks. If they are 5 year olds, you can take action there,” he said. “We have so many more tools and we do not use them strategically and effectively.” Becker said anyone with Covid-19 symptoms – even just one puff – should be tested. “People have this ability to test themselves with a very good degree of confidence,” he said. “The best approach is, if you test yourself and you are positive, then you are approaching a clinical environment, …