Boston University Clinical Testing Lab

To repopulate our three campuses, resume residential learning and student activities, and reopen research labs and clinics, Boston University has taken a comprehensive, multipronged approach to protecting the health and safety of our community and the public at large.

At the center of this effort is testing.

Once it became clear the novel coronavirus would persist into the fall, the University rapidly stood up a clinical testing lab, outfitted within the Rajen Kilachand Center for Integrated Life Sciences Engineering. In addition to a trained staff, the BU Clinical Testing Laboratory is using specialized robots to accelerate testing capacity and, importantly, return results by the end of the next day.

Turnaround time drove the University’s decision to build our own lab, because if a person is tested on Monday but does not learn until Thursday that they are positive, they could have infected many people unknowingly during that time window. A next-day result dramatically reduces that likelihood of spread.

Speed was also key when it came to standing up the new lab. Since May, Catherine Klapperich, director of BU’s Precision Diagnostics Center, and collaborators from across the University have been working 24/7 to scale up a clinically validated plan capable of testing our entire on-campus community of 45,000 people for the presence of SARS-CoV-2, the virus responsible for COVID-19 infections. The University also brought in several senior managers who have experience with laboratory operations at this scale. Initial testing began in late July and is ramping up as more students and employees return to campus in late August.

Below is additional information about the University’s new lab and our testing program.

 

Testing & Collection

The RT-PCR test

The BU Clinical Testing Laboratory will leverage the gold standard test for detecting the presence of coronavirus, known as RT-PCR testing, which stands for reverse transcription-polymerase chain reaction.

Like all coronavirus tests, the RT-PCR test does have the potential to miss detecting a person with coronavirus if the virus wasn’t present or is at low levels in the nostrils, or if an adequate sample wasn’t collected. In addition to screening for coronavirus, each RT-PCR test will also screen for ribonuclease P, or RNase P, an enzyme found inside human cells. Its presence serves as an internal control for a valid sample collection.

Detecting the presence of COVID-19

The test works by turning RNA, unique sequences of genetic information found in humans but also in viruses, into DNA. The DNA can then quickly be multiplied using a process called polymerase chain reaction, or PCR.

That PCR process happens inside a lab machine—called a thermocycler—to amplify DNA into millions or billions of copies of genetic material. In this case, it multiplies the unique genetic code found in coronavirus to a high-enough quantity for the detection of SARS-CoV-2, even if the nasal swab originally captured only trace amounts of it.

Determining results

A test that detects only the presence of RNase P, but not coronavirus, indicates a negative valid result in which there was patient starting material but they were not infected with SARS-CoV-2.

A test that detects the SARS-CoV-2 by RT-PCR and RNase P is considered a positive result, because it indicates the virus may have been present inside a person’s nose. A test that fails to detect either would indicate an invalid result—meaning not enough human cells were captured to be sure that a person isn’t infected. Invalid results will require repeat testing to deliver meaningful results.

Test collection

Students, faculty, and staff will be asked to go to the Healthway site to perform their daily attestation, schedule test collection appointments, and receive results the next day. More information, including test collection locations and testing-frequency categories, can be found on the Screening, Testing & Contact Tracing page on the Back2BU site.

No deep nasal swabs

Members of the BU community will collect their own nasal swabs under observation (called observed self-collection) at designated test collection sites on campus. BU’s test will be easier, and more comfortable, than the deep nasal swabs (called nasopharyngeal swabs) that state labs, hospitals, and medical clinics have largely been using. The nostril test requires a person to rub a swab around the inside edges of their nostrils for several seconds.

Results and accuracy

The swabs are easy to use. They are capable of capturing samples that, when screened using RT-PCR, can detect coronavirus with a 95+ percent accuracy.

Students who test positive will be put in touch with Student Health Services (SHS), and faculty and staff will hear from the Occupational Health Center (OHC), to receive further follow-up if they are beginning to experience symptoms. Residential students will be moved to separate housing for 14 days. People who get invalid test results will be instructed to return to one of the general test collection sites to complete another nasal swab.

Test-kit journey

Observers at the test collection sites will make sure each person swabs correctly and adequately. Then their swab will be placed inside a sterile test tube container filled with liquid saline and marked with a barcode associated with their unique student or employee ID. (Observers will be stationed behind plexiglass barriers; each test collection station will provide six feet of space, and plexiglass barriers, between adjacent stations).

Sealed test tubes containing completed nasal swabs will then be placed in collection boxes, which will be packaged up and stored until they are taken to the BU Clinical Testing Lab. At regular intervals, medical couriers will arrive at test collection sites to transport containers to the BU Clinical Testing Lab in the Kilachand Center.

 

Inside the Lab

Robots in action

The new BU Clinical Testing Laboratory, which employs eight robots—seven of which were rush ordered—will eventually be capable of processing more than 6,000 coronavirus tests per day and, importantly, return results by the end of the next day. The staff will manage these instruments so they perform as expected.

The testing setup was built inside the lab of Douglas Densmore, an ENG associate professor of biomedical and electrical and computer engineering and principal investigator at the DAMP Lab, who stepped in to help from the start. Densmore is an expert on liquid-handling robots and is overseeing the automated aspect of the testing effort.

The job of an automaton

Laboratory technologists will load test tubes, delivered from test collection sites, into seven robots that will distribute and prep the samples to perform coronavirus testing. Some robots will extract the specific viral genetic material from a sample. Other robots will set up the test, putting chemicals into the sample to detect whether the virus RNA is there.

Once the sample has been moved from test tubes to microtiter plates by the robot, alcohol and magnetic beads are used for RNA isolation. These magnetic beads are coated in silica, which binds to genetic material—both viral and human—in the presence of alcohol, a dehydrating liquid. In contrast, the beads do not bind to other molecules—like fats and proteins—that make up human cells.

The beads are then drawn to one side of the test tube with a magnet, and the extra alcohol, fats, and proteins are drained away. Water is added, rehydrating the beads and causing the genetic material—RNA and DNA—to unbind from the beads’ silica surface. The RNA and DNA is then extracted, creating a sample of genetic material that is then amplified using RT-PCR.

From this sample, the PCR machines then look for the presence of RNase P and the SARS-CoV-2 virus. Fluorescent dyes are added to the sample, which bind to two different fragments of the virus. Another dye binds to RNase P. The dyes give off glowing colors if the virus or RNase P is present, allowing a computer program to return a positive, negative, or invalid test result based on what colors appear in a sample.

 

Data & Privacy

Keeping an eye on the data

Aggregated, de-identified testing data will be collected in a digital dashboard, which will be reviewed daily by the BU administration in search of any indicators of community spread.

Safeguarding privacy

Protecting personal health information has been an integral part of the planning for the creation of the BU Clinical Testing Laboratory from the start. The Lab does not hold the names of persons being tested. You can learn more on our Privacy & Health Data page.

 


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