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 of 2020, 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 initially drove the University’s decision to build our own lab. At the start of the pandemic, it was very difficult to get next-day testing results, but a next-day result dramatically reduces the likelihood of a person unknowingly spreading the virus to others. Setting up their own clinical testing lab allowed BU to identify positive cases much more quickly than if they had used an outside facility.

Speed was also key when it came to standing up the new lab. In May 2020, Catherine Klapperich, director of BU’s Precision Diagnostics Center, and collaborators from across the University, worked 24/7 to scale up a clinically validated plan capable of testing our entire on-campus community of 43,000+ 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 2020 and testing of the Boston University community has continued. With the continued presence of SARS-CoV-2 and the emergence of new variant strains, testing of the BU community will continue in the fall of 2021 as we repopulate the campus.

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 leverages 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 go to the Healthway site to perform their symptom attestations, schedule test collection appointments, and receive test 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

Students in the BU community and faculty and staff on the Medical Campus collect their own nasal swabs under observation (called observed self-collection) at designated test collection sites on campus. Employees on the Charles River and Fenway Campuses do a self-test, dropping off their samples at kiosks around campus. BU’s test is easier, and more comfortable, than the deep nasal swabs (called nasopharyngeal swabs) that some state labs, hospitals, and medical clinics use. 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 are put in touch with Student Health Services, and faculty and staff hear from the Occupational Health Center, to receive further follow-up if they are beginning to experience symptoms. Residential students are moved to separate housing for 14 days. People who get invalid test results are 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 make sure each person swabs correctly and adequately. Then, the tester’s swab is 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 are stationed behind plexiglass barriers; each test collection station provides six feet of space, and plexiglass barriers, between adjacent stations). The kiosk sites function in a similar manner, with the only difference being that the collection of the sample is not observed.

Sealed test tubes containing completed nasal swabs are then placed in collection boxes, which are packaged up and stored until they are taken to the BU Clinical Testing Lab. At regular intervals, medical couriers 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 BU Clinical Testing Laboratory, which employs seven robots, is capable of processing more than 6,000 coronavirus tests per day and, importantly, returning 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 & 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

The laboratory is now performing both individual and pooled tube testing. Any students or employees exhibiting COVID symptoms are referred to the Annex for testing and their samples are processed in the lab individually. Asymptomatic students and staff are tested as a pool.

Pooled testing allows further processing efficiency to meet the increased needs for testing of the fully populated Boston University campus in the fall of 2021. Pooling is done when the samples you have provided arrive in the lab. Laboratory technologists combine five individual sample liquids into one tube, which is then processed through the lab. Results off the pool give a negative or presumptive positive result. A negative pool indicates that all five individuals in the pool were negative and those results are delivered to the students and/or employees. If there is a presumptive positive result, the five individual tubes are then pulled from their stored location in the lab and processed again to identify the positive individual from the pool.

Laboratory technologists load test tubes, delivered from test collection sites, into seven robots that distribute and prep the samples to perform coronavirus testing. Some robots extract the specific viral genetic material from a sample. Other robots 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 is collected in a digital dashboard, which is reviewed daily by the BU administration in search of any indicators of community spread.

If there is leftover specimen after your COVID-19 test is performed, the laboratory will remove information that identifies you and make the anonymized specimen available to researchers for educational and scientific purposes. If you have any questions, please contact the Boston University Charles River Campus Institutional Review Board at IRB@bu.edu or 617-358-6115.

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.

 


In the Media