Minipool testing for SARS-CoV-2 RNA in United States blood donors

doi:10.1111/trf.16511

. 2021 Aug;61(8):2384-2391.

doi: 10.1111/trf.16511. Epub 2021 May 27.

Minipool testing for SARS-CoV-2 RNA in United States blood donors

Sonia Bakkour^{1

2}, Paula Saá³, Jamel A Groves³, Leilani Montalvo¹, Clara Di Germanio¹, Sonja M Best⁴, Eduard Grebe^{1

2}, Kristin Livezey⁵, Jeffrey M Linnen⁵, Donna Strauss⁶, Debra Kessler⁶, Mark Bonn⁷, Valerie Green⁸, Phillip Williamson⁸, Steve Kleinman⁹, Susan L Stramer³, Mars Stone^{1

2}, Michael P Busch^{1

2}; NHLBI Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P)

Affiliations

¹ Vitalant Research Institute, San Francisco, California, USA.
² Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.
³ Scientific Affairs, American Red Cross, Gaithersburg, Maryland, USA.
⁴ Laboratory of Virology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, Montana, USA.
⁵ Grifols Diagnostic Solutions, San Diego, California, USA.
⁶ New York Blood Center Enterprises, New York, New York, USA.
⁷ Bloodworks Northwest, Seattle, Washington, USA.
⁸ Creative Testing Solutions, Tempe, Arizona, USA.
⁹ University of British Columbia, Victoria, British Columbia, Canada.

PMID: 34046906
DOI: 10.1111/trf.16511

Minipool testing for SARS-CoV-2 RNA in United States blood donors

Sonia Bakkour et al. Transfusion. 2021 Aug.

. 2021 Aug;61(8):2384-2391.

doi: 10.1111/trf.16511. Epub 2021 May 27.

Authors

Affiliations

¹ Vitalant Research Institute, San Francisco, California, USA.
² Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.
³ Scientific Affairs, American Red Cross, Gaithersburg, Maryland, USA.
⁴ Laboratory of Virology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, Montana, USA.
⁵ Grifols Diagnostic Solutions, San Diego, California, USA.
⁶ New York Blood Center Enterprises, New York, New York, USA.
⁷ Bloodworks Northwest, Seattle, Washington, USA.
⁸ Creative Testing Solutions, Tempe, Arizona, USA.
⁹ University of British Columbia, Victoria, British Columbia, Canada.

PMID: 34046906
DOI: 10.1111/trf.16511

Abstract

Background: SARS-CoV-2 RNA prevalence in blood donors from large geographic areas of high community transmission is limited. We tested residual donor plasma minipools (MPs) to determine SARS-CoV-2 RNAemia prevalence in six United States areas.

Study design/methods: Blood donations collected from 7 March 2020 to 25 September 2020 were tested for SARS-CoV-2 RNA (vRNA) in MP of 6 or 16 donations using the Grifols Procleix SARS-CoV-2 research-use only (RUO) transcription-mediated amplification (TMA) assay. Reactive results were confirmed using an alternate target region TMA assay. Reactive MPs were tested by TMA after serial dilution to estimate viral load. Testing for anti-SARS-CoV-2 antibodies and infectivity was performed.

Results: A total of 17,995 MPs corresponding to approximately 258,000 donations were tested for vRNA. Three confirmed reactive MP16 were identified. The estimated prevalence of vRNA reactive donations was 1.16/100,000 (95% CI 0.40, 3.42). The vRNA-reactive samples were non-reactive for antibody, and the estimated viral loads of the (presumed single) positive donations within each MP ranged from <1000 to <4000 copies/ml. When tested, no infectivity was observed in inoculated permissive cell cultures.

Discussion: Blood donation MP-nucleic acid testing (NAT) indicated that SARS-CoV-2 RNAemia is infrequent and, when detected, the vRNA was at low concentrations. Only one RNA-reactive MP could be tested for infectivity for operational reasons and was not infectious in cell culture. These findings support current recommendations from international and national regulatory agencies to not screen donors by NAT.

Keywords: RNAemia; SARS-CoV-2; blood donors; minipool; plasma; transcription-mediated amplification.

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References

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[1] Byambasuren O, Cardona M, Bell K, Clark J, McLaws ML, Glasziou P. Estimating the extent of asymptomatic COVID-19 and its potential for community transmission: systematic review and meta-analysis. Off J Assoc Med Microbiol Infect Dis Can. 2020;5:223-34.

[2] Byambasuren O, Cardona M, Bell K, Clark J, McLaws ML, Glasziou P. Estimating the extent of asymptomatic COVID-19 and its potential for community transmission: systematic review and meta-analysis. Off J Assoc Med Microbiol Infect Dis Can. 2020;5:223-34.

[3] Cevik M, Tate M, Lloyd O, Maraolo AE, Schafers J, Ho A. SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis. Lancet Microbe. 2021;2:e13-22.

[4] Cevik M, Tate M, Lloyd O, Maraolo AE, Schafers J, Ho A. SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis. Lancet Microbe. 2021;2:e13-22.

[5] Rolfes MA, Grijalva CG, Zhu Y, et al. Implications of shortened quarantine among household contacts of index patients with confirmed SARS-CoV-2 infection - Tennessee and Wisconsin, April-September 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1633-7.

[6] Rolfes MA, Grijalva CG, Zhu Y, et al. Implications of shortened quarantine among household contacts of index patients with confirmed SARS-CoV-2 infection - Tennessee and Wisconsin, April-September 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1633-7.

[7] Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395:497-506.

[8] Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395:497-506.

[9] Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of SARS-CoV-2 in different types of clinical specimens. JAMA. 2020;323:1843-4.

[10] Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of SARS-CoV-2 in different types of clinical specimens. JAMA. 2020;323:1843-4.

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Minipool testing for SARS-CoV-2 RNA in United States blood donors

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Minipool testing for SARS-CoV-2 RNA in United States blood donors

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