In the fast-changing and complex world of testing for the COVID-19 virus, CHA Everett officials announced this week what is a major piece of good news for the group’s network of community hospitals in Everett, Cambridge and Somerville – that being the offering of a rapid test that can be done in-house with results in hours rather than days.
Dr. Rebecca Osgood, chief of pathology and clinical labs for Cambridge Health Alliance (CHA), said on Monday that the hospital network has rolled out new rapid testing capabilities at its Cambridge location, and will soon have it up and running at the CHA Everett hospital as well. It is a major breakthrough for the communities served by CHA Everett – which have experienced some of the highest rates of infection in the state – whereby more people can be tested and get results much faster.
“Up until now, we’ve not been able to do testing in-house,†she said. “We’ve had to send our tests out to three labs after collecting samples…I’m happy to announce as of Monday we have our own in-house testing with a real-time PCR…One of my goals is to improve the lab resource at CHA Everett. We will be having the test at that site. Currently we’re only using it at Cambridge…but bringing it to Everett is important because Everett is very, very busy. It’s really a very, very busy campus. It is really a community that has benefitted from the presence of CHA being there in the community for them.â€
Testing for the COVID-19 virus has been a confusing matter for doctors, public health officials, patients and the general public. Almost weekly there seems to be some sort of breakthrough, but each test seems to have its own set of positives and negatives. Keeping track of just how one can be tested is next to impossible. However, Dr. Osgood clarified exactly how it’s being done at CHA.
The new quick-test that is now being offered is the Cepheid Analyzer Xpert Xpress system – which is compatible with lab equipment at the CHA campuses. It takes just 4-6 hours to get a result, and is done with a nasal swab. It was developed, like most tests, very quickly and only given emergency authorization from the federal government on March 22.
CHA Everett has also been using three other real-time PCR tests that have to be sent out for lab analysis. They are using a COC Assay test that goes out to the State Lab in Jamaica Plain and takes 2.1 days on average for a result. They also partner with Labcorp on testing, which uses the Roche Analyzer test and has a turnaround time of 1.8 days. Meanwhile, their clinical affiliate Beth Israel has been working with CHA Everett to do testing using the Abbott quick-test, which is sent out to Beth Israel for analysis and returned on average in 0.93 days.
She said they are doing about 140 to 160 tests per day and, as of mid-day April 13, had completed 3,071 tests since around March 11.
“All of these tests are pretty rapidly produced, but when you send them out to another lab, it’s a lot of transportation time,†she said. “It’s really a breakthrough to have testing done here in our own lab. It means a result in 4 to 6 hours…The other tests are all about one or two days, so being able to do it in-house is a much better situation. Time is very important to our patients.â€
Dr. Osgood said they hope to be able to radically expand testing soon in Everett to help with the next stage of treating and detecting the sickness. However, that is hampered by one thing – a lack of swabs.
“Our plan is really to expand testing throughout the communities we’re involved in I believe,†she said. “That is something to expect, but what’s holding us back is the swab availability and the inability to get in new swabs. I’ve tried and tried to order more, but we can’t get them in.â€
She said, as a pathologist, not having swabs to use – a standard and plentiful piece of equipment in normal times for any medical lab – would have never occurred to her.
“Absolutely never,†she said. “Who would have ever believed that I would have asked a colleague at the MIT Labs if they can 3-D print a swab? No one could have predicted that, but we have asked.â€
NEW TESTING COMING
While all of the testing right now is being done through nasal or oral swabs with what is known as rapid-time PCR testing, a new test is coming online known as serology – which tests for antibodies in the blood.
Rather than taking a sample from the nose, the test is done by taking blood. Lab workers then analyze the blood for antibodies from the immune system, which helps them to know if one has had the COVID-19 virus and has recovered.
She said within a week, they hope to be able to do such testing with their partner, Labcorp. Within two weeks, she said they hope to be able to have the testing in their in-house lab. She said it is this testing that has been on the news a lot lately, and particularly the one that is talked about a lot in presidential press conferences.
“When you get a test in-house like that, we can’t start it right away,†she said. “That’s hard to understand, even for doctors. We have to go through a quality control process and make sure it meets the standards.â€
Once that is up and running, it will prevent needing to use swabs, but it will also be able to likely tell if you have had the virus and recovered. It is not a new concept, she said, and has been used for years to detect if one has had the mumps or any other such disease.
“It is simply measuring the immune system anti-body response to the organism,†she said. “In this case, testing will look at your anti-body response to COVID-19. If you have a good enough response, we’ll know you had the virus. Those patients are going to be important for the Red Cross because the Red Cross is looking for donors who have recovered after a certain period of time. They will be able to donate their plasma to help our patients who are struggling with COVID-19.â€
There has already been great work and research done on treating sick patients with anti-bodies in the blood of recovered patients, and it does seem to have good results. Once those serology tests are performed, the Red Cross is hoping to be able to provide this therapy more often on patients who are sick.
It will also be an important part of figuring out if there is natural immunity to the COVID-19 virus, and whether or not someone can get it more than once. If the serology test shows that someone has had the virus, and then they show up sick again – it will raise many new questions that have not been posed just yet.
False Negatives
There are also many concerns with testing for COVID-19 due to potential false negatives – where a test shows that a person doesn’t have the virus, but they actually do have it.
It does happen, Dr. Osgood said.
The real-time PCR tests use a nasal or oral swab to collect viral material from the upper respiratory system. Detecting the virus depends on timing and the success of the test collection – a collection that is very uncomfortable and requires the swab to be inserted far into the sinuses for up to 30 seconds.
In that method, only about 60 to 70 percent of those with the virus had a positive test, according to data released from testing in China. A lower respiratory test was more accurate, around 90 to 100 percent. However, that requires a timely, invasive procedure to gather samples from the lungs.
Some of the restrictions on the upper respiratory test are whether or not the sample was done correctly, and whether the patient has come in too early.
“You actually might have a falsely negative specimen at the beginning,†she said. “There is no perfect test. We’re taught in medical school there are always tests with false positives and false negatives. In this test, false positives are very rare, but false negatives can happen…It could be the testing wasn’t done as vigorously as it should have been. You’re supposed to be in there 15 to 30 seconds and it is uncomfortable. It could be you came in too early and your virus level isn’t as high.â€
She said that is one reason they use the test as just one piece of data to diagnose the virus. CHA Everett is tending to look at the whole patient picture, including what kinds of symptoms they have. If they test negative, but have all of the correct symptoms of COVID-19, there is an assumption that the patient is probably sick.
Right now, at the CHA network, they are testing positive at a rate of 31.9 percent. That is 10 percent higher than the state average of 21.9 percent. Overall, employees at CHA are testing a lot lower than both averages – around 10 to 15 percent positive, which is good news.
“That is consistent with other hospitals in the area,†she said.
Overall Challenges for Testing
The challenge overall for increased testing of more people in Everett, Chelsea and Revere will be materials. As Dr. Osgood said above, swabs are in short supply, but testing kits are also in short supply, as well as equipment.
While they have the Cepheid machinery, they have also tried to procure the Abbott ID Now machinery which helps process the Abbott quick-tests.
“I’ve asked for that machine and they think it will be months,†she said. “They can’t even tell me when I’ll be able to be put on a wait list for an instrument.â€
She said other testing kits are also in short supply right now.
“Just like masks goggles, gowns and gloves, testing is in really short supply,†she said. “We try to get an order in…The pandemic has really shown how important it is to have all these supplies ready at any time. It’s really been an interesting experience.â€