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Clinical Trial
. 2023 Feb;108(2):137-140.
doi: 10.1136/archdischild-2022-324353. Epub 2022 Sep 9.

Lateral flow test performance in children for SARS-CoV-2 using anterior nasal and buccal swabbing: sensitivity, specificity, negative and positive predictive values

Rachel Harwood  1   2 , Laura Rad  3 , Christopher Kelly  4 , Cliff Shelton  5 , Elizabeth Shepherd  6 , Marion Roderick  7 , Elizabeth Whittaker  8 , Steven Dyke  9 , Sanjay Vallabh Patel  10 , Nick Gent  9 , Simon E Kenny  11   12
Affiliations
Clinical Trial

Lateral flow test performance in children for SARS-CoV-2 using anterior nasal and buccal swabbing: sensitivity, specificity, negative and positive predictive values

Rachel Harwood et al. Arch Dis Child. 2023 Feb.

Abstract

Objective: To determine if the sensitivity of the lateral flow test is dependent on the viral load and on the location of swabbing in the respiratory tract in children.

Design: Phase 1: Routinely performed reverse transcriptase PCR (RT-PCR) using nose and throat (NT) swabs or endotracheal (ET) aspirates were compared with Innova lateral flow tests (LFTs) using anterior nasal (AN) swabs. Phase 2: RT-PCR-positive children underwent paired AN RT-PCR and LFT and/or paired AN RT-PCR and buccal LFT.

Setting: Tertiary paediatric hospitals.

Patients: Children under the age of 18 years. Phase 1: undergoing routine testing, phase 2: known SARS-CoV-2 positive.

Results: Phase 1: 435 paired swabs taken in 431 asymptomatic patients resulted in 8 positive RT-PCRs, 9 PCR test failures and 418 negative RT-PCRs from NT or ET swabs. The test performance of AN LFT demonstrated sensitivity: 25% (4%-59%), specificity: 100% (99%-100%), positive predictive value (PPV): 100% (18%-100%) and negative predictive value (NPV): 99% (97%-99%).Phase 2: 14 AN RT-PCR-positive results demonstrated a sensitivity of 77% (50%-92%) of LFTs performed on AN swabs. 15/16 paired buccal LFT swabs were negative.

Conclusion: The NPV, PPV and specificity of LFTs are excellent. The sensitivity of LFTs compared with RT-PCR is good when the samples are colocated but may be reduced when the LFT swab is taken from the AN. Buccal swabs are not appropriate for LFT testing. Careful consideration of the swabbing reason, the tolerance of the child and the requirements for test processing (eg, rapidity of results) should be undertaken within hospital settings.

Trial registration number: NCT04629157.

Keywords: epidemiology; infectious disease medicine; paediatrics.

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Conflict of interest statement

Competing interests: Public Health England, now UK Health and Security Agency, supplied the lateral flow tests used within the study and contributed £100,000 towards the running of the study.

Figures

Figure 1
Figure 1
Comparison between cycle threshold (CT) value for reverse transcriptase PCR (RT-PCR) and the result of lateral flow test (1—positive, 0—negative).
See this image and copyright information in PMC

References

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