A new pediatric tuberculosis (TB) screening test can be administered in one visit, compared to the traditional test, which requires two visits.
From virtual and augmented reality, to smart pills and artificial intelligence, children's hospitals are leveraging advanced technology and trends that will forever change the way they deliver care. While prior generations would be impressed by these technological advancements, there are techniques still in clinical use that these earlier generations would say, "Why are they still doing that?"
For example, there is a test in daily use at children's hospitals across the U.S. that pre-dates World War II, Wrigley Field and the Titanic: the tuberculin skin test (TST). But, in September, the Food and Drug Administration (FDA) cleared the T-SPOT.TB test as the first interferon-gamma release assay (IGRA) for use in pediatric tuberculosis (TB) screening for children ages 2 and up.
This new test advances traditional TB screening in children to an easy, accurate and widely accessible platform that is accepted under the American Academy of Pediatrics, the Centers for Disease Control and Prevention and the CDC Civil Surgeons guidelines.
While transformational technology can capture the imagination, sometimes it's the simplest things that can fundamentally change pediatric care. Here are two benefits of switching to a TB test like the T-SPOT.TB test for improved patient care.
Reduced patient encounters
According to a study by Commonwealth Fund, outpatient visits to ambulatory practices declined by nearly 60% in early April 2020, and visits are still well below what was seen prior to the pandemic. The trend is pronounced in pediatric outpatient settings.
Researchers noted, unsurprisingly, "The decline in visits reflects the clinician's efforts to decrease the risk of COVID-19 transmission." With COVID-19 rates stubbornly high in the U.S., this approval comes at a perfect time for pediatric providers.
First, it's critical when patients are willing to present for care, their diagnostics are handled in the fewest visits possible. Additionally, many providers are now constrained on appointment slots and have implemented creative ways to keep patients out of the waiting room.
The T-SPOT.TB test can be collected and then resulted in one visit. The 100-year-old TST still requires two visits—one for the application and one for the reading. This is a simple and safe approach to reducing patient encounters by 50%.
Clinical limitations of the TST are well documented. The CDC notes that while the TST is simple to perform and does not require phlebotomy, the test does require trained personnel to administer the intradermal injection, is subject to variability in interpretation and has risk of false positive results due to cross-reactivity to both the BCG vaccine and non-TB mycobacteria.
The TST is also not "pain free" for a child. Common side effects include bleeding and blistering at the injection site, a hard lump at the site and hives. All this for a 100-year-old test, with a sensitivity of 71% to 82% or lower in patients with compromised immune systems. Poor sensitivity can lead to false positive results, more patient triage or non-compliance for returning for test interpretation.
TB test accuracy matters
Conversely, whether TB screening is completed for "check the box" reasons or in response to signs, symptoms or risk of TB, the test must be accurate and respond to the risk of the patient you are screening. Based on a peer reviewed study of over 3,600 children under the age of 15, switching from the TST to an IGRA, like the T-SPOT.TB test, could reduce unnecessary chest x-rays and treatments by up to two-thirds in non-U.S. born children.
Test accuracy matters and, with a test sensitivity and specificity of greater than 95%, as well as an invalid rate of less than 1%, pediatric providers can maximize the likelihood of getting the right result in one visit with the T-SPOT.TB test.
IGRAs have been commercially available for over a decade however, before September, no IGRA has been cleared by the FDA for use in pediatric populations. Use this advancement to increase test accuracy and reduce patient encounters for patients 2 and older.
The T-SPOT.TB test is available nationally thought Quest Diagnostics and through numerous laboratories across the U.S. T-SPOT and the Oxford Immunotec logo are registered trademarks of Oxford Immunotec Ltd. Quest Diagnostics is a registered trademark of Quest Diagnostics. © 2020 Oxford Immunotec. All rights reserved. TB-US-ART-MPN391-0001 V1