Use, Safety Assessment, and Implementation of Two Point-of-Care Tests for COVID-19 Testing

Megan Hahn, PhD; Aaron Olsen, PhD; Kindra Stokes, PhD; Randal C. Fowler, PhD, D(ABMM); Rui Gu, PhD; Shellanne Semple-Lytch; Andrea DeVito, MPH, CPH; Philip Kurpiel, PhD; Scott Hughes, PhD; Jennifer L. Rakeman, PhD

Disclosures

Am J Clin Pathol. 2021;156(3):370-380. 

In This Article

Abstract and Introduction

Abstract

Objectives: The Abbot ID NOW COVID-19 assay and Quidel Sofia 2 SARS Antigen FIA are point-of-care assays that offer rapid testing for severe acute respiratory syndrome coronavirus 2 viral RNA and nucleocapsid protein, respectively. Given the utility of these devices in the field, we investigated the feasibility and safety of using the ID NOW and Sofia assays in the public health response to the coronavirus disease 2019 pandemic and in future public health emergencies.

Methods: A combination of utilization and contamination testing in addition to a review of instrument workflows was conducted.

Results: Utilization testing demonstrated that both tests are intuitive, associated with high user test success (85%) in our study, and could be implemented by staff after minimal training. Contamination tests revealed potential biosafety concerns due to the open design of the ID NOW instrument and the transfer mechanisms with the Sofia. When comparing the workflow of the ID NOW and the Sofia, we found that the ID NOW was more user-friendly and that the transfer technology reduces the chance of contamination.

Conclusions: The ID NOW, Sofia, and other emerging point-of-care tests should be used only after careful consideration of testing workflow, biosafety risk mitigations, and appropriate staff training.

Introduction

The availability and utility of authorized Clinical Laboratory Improvement Amendments waived tests (https://www.cdc.gov/labquality/waived-tests.html) for nonlaboratory field applications have revolutionized the way that we address testing during disease outbreaks, epidemics, and pandemics. These point-of-care tests (POCTs) require relatively little training and laboratory experience and allow for rapid time to results. If an instrument is required for the test, it is generally small and portable. These features allow health care providers to (1) identify individuals that may further spread disease, (2) reduce the risk of transmission in congregate settings, (3) make rapid clinical decisions, and (4) run or care for the devices with a minimal need for training. As a result, POCTs enable testing at remote care centers and field locations and in some instances may provide a lower overall cost per test than laboratory-based tests and facilitate greater frequency of testing.[1–3] While POCTs have been in use for the past two decades to diagnose diseases, including streptococcal throat infections and influenza, the coronavirus disease 2019 (COVID-19) pandemic has highlighted their ability to increase general testing availability in emergency situations.[4–7] Testing demand and impact of the pandemic on production and availability of supplies for testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in shortages of swabs, viral transport media, and RNA extraction kits.[4–7] Due to limited reagents and collection supplies, laboratory testing capacity is often not able to meet testing demand at the beginning of a pandemic response, as was observed with SARS-CoV-2. As pandemic response progresses and laboratory testing expands, clinics, schools, and community testing sites then may not have the capacity to meet surveillance demands. This combination of limited clinical testing capacity and abundance of cases has prompted international public health initiatives to ramp up COVID-19 field testing and, through this, the use of POCTs.[8]

We designed a study to evaluate the benefits and drawbacks of two instrument-based POCTs—the Abbott ID NOW COVID-19 test (ID NOW), which is an RNA detection test for SARS-CoV-2, and the Sofia 2 SARS Antigen FIA test (Sofia)—in nonlaboratory settings staffed by assay users with minimal experience using the instruments Table 1. Overall, we found that while both instruments have potential for use in nonlaboratory settings, staff will require proper training and practice to avoid potential contamination and unintended spread of infectious material.

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