ID NOW Performance, From Researchers in the Field

Reliable test results depend on many factors and conformity to the way the test was designed to be run.

Diagnostics Testing|May.27, 2020

ID NOW's test for COVID-19 is proving to be an essential tool in fighting this pandemic as it is the fastest and most widely available rapid point of care test. Its portability and speed are allowing it to be used in some of the most critical settings where results in minutes are needed. That result not only allows healthcare providers to appropriately screen the patient for treatment, but it can also detect the SARS-CoV-2 virus after exposure to help diagnose COVID-19.

Testing has come a long way in a short time. ID NOW was one of the first tests to reach the front lines – it was a huge step forward in caring for patients and protecting frontline workers.

Since we've first made the test available, Abbott has provided guidance to healthcare workers on the proper methods for collecting swab samples. Reliable test results depend on many factors: specimen collection, handling, storage, transport and conformity to the way the test was designed to be run. The research community has also learned more about the virus and understanding why the virus detection window is important for SARS-CoV-2 molecular tests.

For example, a study from Johns Hopkins found that even the most sensitive lab-based molecular tests can have false negatives early on in the infection cycle when viral load levels are ramping up and toward the end of the infection cycle when viral load levels are winding down. "These results affirm what we know about how viruses generally behave in the human body," said John Hackett, Jr., Ph.D., divisional vice president of Applied Research and Technology for Abbott's diagnostics business. "There's typically a sweet spot when sensitivity is highest, and as the study data shows, false negatives are possible depending on how strongly the body is 'shedding' the virus."

We are continuing to work with healthcare workers, researchers and health authorities to understand the performance of the ID NOW COVID-19 test, how best to use the test for optimal results and to learn about customers' experiences in the field. We will use this data and real-world experience to improve the next generation test we are developing.

Interim analysis of two ongoing multi-site clinical studies — one among urgent care clinics and the other conducted with hospitalized and nursing home patients — show ID NOW’s COVID-19 rapid test demonstrating strong agreement to lab-based molecular polymerase chain reaction (PCR) instruments when the majority of people are tested in the first seven days post onset symptoms. The early results from the urgent care clinics showed ≥94.7% in positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) when compared to two different lab-based PCR reference tests. These initial findings strongly suggest ID NOW — which delivers results in minutes, not days — performs best when patients are tested earlier following their first symptoms.

If a study surfaces purporting false negative results, we're following up with authors directly and asking important questions of the researchers such as: "Was ID NOW used as intended in the product's directions?" "Were the samples in the study randomized?" "How were the samples stored and transported?" "Were the samples diluted using viral transport media?" "Were the samples tested immediately?" "How late in the infection cycle were the patients who were tested?" "Do the patients reflect a normal distribution of people who would present with clinical symptoms?"

The answers to these questions reflect important information on how studies are designed and conducted. These answers matter.

We've shipped 2 million rapid tests as of May 18, 2020, and there have been 15 false negative complaints reported to the FDA from real-world use.

Here are the results from two recent studies:

Everett Clinic, Washington State

A new study conducted by Yuan-Po Tu, CVM, M.D., leading COVID-19 researcher from the Everett Clinic (part of Optum), evaluated 955 patients in an outpatient environment. Swab collection was done according to recommendations and the swabs were tested onsite and were run within 5-15 minutes of collection.

The results:

  • Out of 955 patients, 23 were found to be positive for COVID-19 using a lab-based test.
  • ID NOW picked up 21 of those positive patients, demonstrating 91.3% sensitivity and 100% specificity.
  • This data was recently presented on a webinar conducted by the Association for Molecular Pathology and will be submitted for publication soon.

City of Detroit, Michigan

City of Detroit Medical Director, Najibah Rehman, M.D., took 50 samples from people who tested negative for COVID-19 on ID NOW and had them tested at the state lab's high-volume molecular instrument, which is considered the gold standard. Swabbing was done using the proper direct swab method. One sample was disregarded due to a software problem.

The results:

  • 48 of the 49 samples were confirmed to be negative for COVID-19, demonstrating 98% agreement between the two testing platforms.
  • One of the 49 was inconclusive, so Dr. Rehman re-tested and the test also came back negative.
  • According to the study authors, the one false negative could have been due to early onset of infection, when the viral load could have been below ID NOW's detectable threshold.
  • Read more about the results in the Detroit News.

"Our customers are telling us that they're seeing positivity rates from ID NOW testing at or above local community infection rates, which means that ID NOW is detecting the virus at a similar level as other testing methods," according to John Hackett, Jr., PhD. "If there were any systemic problem with ID NOW producing false negatives, that wouldn't be the case."

CVS Health recently echoed this same finding when it said that “the percentage of positive test results [on ID NOW], from our data off of the large scale sites, has been higher than the averages." Other customers tell us that ID NOW is detecting positive in asymptomatic people with known exposure.

We are in a dynamic time when science is happening at an unprecedented rate and ID NOW is the fastest and most widely available rapid test. ID NOW is about bringing the test to where people come for care, so that loved ones can visit family members in the hospital, police can patrol the streets, workers in critical infrastructure can stay on the job, healthcare workers can go to work, interstate commerce can proceed, and medical procedures can be scheduled.

As the world gets better at fighting this pandemic, so will we. We'll continue to optimize our tests and we won't rest until this pandemic is over. That's what we did in 1985, when we brought the first FDA-approved HIV test to market, and have continued to do as recently as last year, when we identified a new HIV strain and then made sure our tests would detect it. You have our commitment we'll do the same for COVID-19 too.

This story was originally published on May 20, 2020. It was updated to include reference to our  announcement  on interim clinical study data on ID NOW COVID-19 rapid test.

The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.