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Performance and Operational Evaluation of the Access Bio CareStart Rapid Antigen Test in a High-Throughput Drive-Through Community Testing Site in Massachusetts.
Pollock, Nira R; Tran, Kristine; Jacobs, Jesica R; Cranston, Amber E; Smith, Sita; O'Kane, Claire Y; Roady, Tyler J; Moran, Anne; Scarry, Alison; Carroll, Melissa; Volinsky, Leila; Perez, Gloria; Patel, Pinal; Gabriel, Stacey; Lennon, Niall J; Madoff, Lawrence C; Brown, Catherine; Smole, Sandra C.
  • Pollock NR; Department of Laboratory Medicine, Boston Children's Hospital, Boston, Massachusetts, USA.
  • Tran K; Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA.
  • Jacobs JR; Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA.
  • Cranston AE; Laboratory Leadership Service, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
  • Smith S; Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA.
  • O'Kane CY; Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA.
  • Roady TJ; Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA.
  • Moran A; Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA.
  • Scarry A; Lawrence General Hospital, Lawrence, Massachusetts, USA.
  • Carroll M; Lawrence General Hospital, Lawrence, Massachusetts, USA.
  • Volinsky L; Lawrence General Hospital, Lawrence, Massachusetts, USA.
  • Perez G; Lawrence General Hospital, Lawrence, Massachusetts, USA.
  • Patel P; Lawrence General Hospital, Lawrence, Massachusetts, USA.
  • Gabriel S; Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA.
  • Lennon NJ; Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA.
  • Madoff LC; Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA.
  • Brown C; Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA.
  • Smole SC; Division of Infectious Disease and Immunology, Department of Medicine, University of Massachusetts Medical Center, Worcester, Massachusetts, USA.
Open Forum Infect Dis ; 8(7): ofab243, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1305435
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
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ABSTRACT

BACKGROUND:

To facilitate deployment of point-of-care testing for severe acute respiratory syndrome coronavirus 2, we evaluated the Access Bio CareStart COVID-19 Antigen test in a high-throughput, drive-through, free community testing site using anterior nasal (AN) swab reverse-transcription polymerase chain reaction (RT-PCR) for clinical testing.

METHODS:

Consenting symptomatic and asymptomatic children (≤18 years) and adults received dual AN swabs. CareStart testing was performed with temperature/humidity monitoring. All tests had 2 independent reads to assess interoperator agreement. Patients with positive CareStart results were called and instructed to isolate pending RT-PCR results. The paired RT-PCR result was the reference for sensitivity and specificity calculations.

RESULTS:

Of 1603 participants, 1245 adults and 253 children had paired RT-PCR/CareStart results and complete symptom data. Eighty-three percent of adults and 87% of children were asymptomatic. CareStart sensitivity/specificity were 84.8% (95% confidence interval [CI], 71.1-93.7)/97.2% (95% CI, 92.0-99.4) and 85.7% (95% CI, 42.1-99.6)/89.5% (95% CI, 66.9-98.7) in adults and children, respectively, within 5 days of symptoms. Sensitivity/specificity were 50.0% (95% CI, 41.0-59.0)/99.1% (95% CI, 98.3-99.6) in asymptomatic adults and 51.4% (95% CI, 34.4-68.1)/97.8% (95% CI, 94.5-99.4) in asymptomatic children. Sensitivity in all 234 RT-PCR-positive people was 96.3% with cycle threshold (Ct) ≤25, 79.6% with Ct ≤30, and 61.4% with Ct ≤35. All 21 false-positive CareStart tests had faint but normal bands. Interoperator agreement was 99.5%. Operational challenges included identification of faint test bands and inconsistent swab elution volumes.

CONCLUSIONS:

CareStart had high sensitivity in people with Ct ≤25 and moderate sensitivity in symptomatic people overall. Specificity was unexpectedly lower in symptomatic versus asymptomatic people. Excellent interoperator agreement was observed, but operational challenges indicate that operator training is warranted.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Experimental Studies / Prognostic study Language: English Journal: Open Forum Infect Dis Year: 2021 Document Type: Article Affiliation country: Ofid

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Experimental Studies / Prognostic study Language: English Journal: Open Forum Infect Dis Year: 2021 Document Type: Article Affiliation country: Ofid