BACKGROUND: The use of a remote specimen collection strategy employing a kit designed for unobserved self-collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) can decrease the use of personal protective equipment (PPE) and exposure risk. To assess the impact of unobserved specimen self-collection on test performance, we examined results from a SARS-CoV-2 qualitative RT-PCR test for self-collected specimens from participants in a return-to-work screening program and assessed the impact of a pooled testing strategy in this cohort. METHODS: Self-collected anterior nasal swabs from employee return-to-work programs were tested using the Quest Diagnostics Emergency Use Authorization SARS-CoV-2 RT-PCR. The cycle threshold (Ct) values for the N1 and N3 N-gene targets and a human RNase P (RP) gene control target were tabulated. For comparison, we utilized Ct values from a cohort of health care provider-collected specimens from patients with and without coronavirus disease 2019 symptoms. RESULTS: Among 47 923 participants, 1.8% were positive. RP failed to amplify for 13/115 435 (0.011%) specimens. The median (interquartile range) Cts were 32.7 (25.0-35.7) for N1 and 31.3 (23.8-34.2) for N3. Median Ct values in the self-collected cohort were significantly higher than those of symptomatic but not asymptomatic patients. Based on Ct values, pooled testing with 4 specimens would have yielded inconclusive results in 67/1268 (5.2%) specimens but only a single false-negative result. CONCLUSIONS: Unobserved self-collection of nasal swabs provides adequate sampling for SARS-CoV-2 RT-PCR testing. These findings alleviate concerns of increased false negatives in this context. Specimen pooling could be used for this population, as the likelihood of false-negative results is very low when using a sensitive, dual-target methodology.
BACKGROUND: The use of a remote specimen collection strategy employing a kit designed for unobserved self-collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) can decrease the use of personal protective equipment (PPE) and exposure risk. To assess the impact of unobserved specimen self-collection on test performance, we examined results from a SARS-CoV-2 qualitative RT-PCR test for self-collected specimens from participants in a return-to-work screening program and assessed the impact of a pooled testing strategy in this cohort. METHODS: Self-collected anterior nasal swabs from employee return-to-work programs were tested using the Quest Diagnostics Emergency Use Authorization SARS-CoV-2 RT-PCR. The cycle threshold (Ct) values for the N1 and N3 N-gene targets and a human RNase P (RP) gene control target were tabulated. For comparison, we utilized Ct values from a cohort of health care provider-collected specimens from patients with and without coronavirus disease 2019 symptoms. RESULTS: Among 47 923 participants, 1.8% were positive. RP failed to amplify for 13/115 435 (0.011%) specimens. The median (interquartile range) Cts were 32.7 (25.0-35.7) for N1 and 31.3 (23.8-34.2) for N3. Median Ct values in the self-collected cohort were significantly higher than those of symptomatic but not asymptomatic patients. Based on Ct values, pooled testing with 4 specimens would have yielded inconclusive results in 67/1268 (5.2%) specimens but only a single false-negative result. CONCLUSIONS: Unobserved self-collection of nasal swabs provides adequate sampling for SARS-CoV-2 RT-PCR testing. These findings alleviate concerns of increased false negatives in this context. Specimen pooling could be used for this population, as the likelihood of false-negative results is very low when using a sensitive, dual-target methodology.
Authors: Mark G Thompson; Jeannette R Ferber; Roxana Odouli; Donna David; Pat Shifflett; Jennifer K Meece; Allison L Naleway; Sam Bozeman; Sarah M Spencer; Alicia M Fry; De-Kun Li Journal: Influenza Other Respir Viruses Date: 2015-05 Impact factor: 4.380
Authors: Yuan-Po Tu; Rachel Jennings; Brian Hart; Gerard A Cangelosi; Rachel C Wood; Kevin Wehber; Prateek Verma; Deneen Vojta; Ethan M Berke Journal: N Engl J Med Date: 2020-06-03 Impact factor: 91.245
Authors: Denise J McCulloch; Ashley E Kim; Naomi C Wilcox; Jennifer K Logue; Alex L Greninger; Janet A Englund; Helen Y Chu Journal: JAMA Netw Open Date: 2020-07-01
Authors: K E Hanson; A P Barker; D R Hillyard; N Gilmore; J W Barrett; R R Orlandi; S M Shakir Journal: J Clin Microbiol Date: 2020-10-21 Impact factor: 5.948
Authors: Larry K Kociolek; William J Muller; Rebecca Yee; Jennifer Dien Bard; Cameron A Brown; Paula A Revell; Hanna Wardell; Timothy J Savage; Sarah Jung; Samuel Dominguez; Bijal A Parikh; Robert C Jerris; Sue C Kehl; Aaron Campigotto; Jeffrey M Bender; Xiaotian Zheng; Emily Muscat; Matthew Linam; Lisa Abuogi; Christiana Smith; Kelly Graff; Ariel Hernandez-Leyva; David Williams; Nira R Pollock Journal: J Clin Microbiol Date: 2020-12-17 Impact factor: 5.948