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

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. 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. 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. 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.

Bakkour S ，Saá P ，Groves JA ，Montalvo L ，Di Germanio C ，Best SM ，Grebe E ，Livezey K ，Linnen JM ，Strauss D ，Kessler D ，Bonn M ，Green V ，Williamson P ，Kleinman S ，Stramer SL ，Stone M ，Busch MP ，NHLBI Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) ... -  《-》

Low rate of RNAemia in blood donations collected during the first wave of COVID-19 in France.

To investigate the transmission of SARS-CoV-2 via blood, we conducted retrospective molecular screening in blood donated during the first pandemic peak in the two French regions with the highest community transmission. Archived plasma samples randomly selected from donations collected between March 23 and 29, 2020, in Eastern and Northern regions of France were tested for SARS-CoV-2 RNA in minipools of 4 donations (MP4) using the Grifols ProcleixSARS-CoV-2 assay. Reactive MP4 and the four corresponding plasmas were further tested with alternative RT-PCRs and sequencing. Testing for SARS-CoV-2 antibodies and in vitro infectivity in cell culture were also performed. Among the 2818 MP4 (corresponding to 9672 donations) tested for viral RNA, 5 were weakly reactive. Among the 20 plasmas included in these five MP4, one presented low-level reactivity with RT-PCRs and Procleix SARS-CoV-2 and was confirmed on sequencing. The estimated prevalence was 1.03/10,000 (95% CI 0-3.1). The 20 plasmas were antibody nonreactive and none of them showed cytopathic effects in cell culture. When recalled, the index-donor declared having had symptoms compatible with SARS-CoV-2 infection a few days after donation. The two immunocompromised recipients transfused with red blood cells and an inactivated pooled platelet product did not develop COVID-19. Our results indicated a low prevalence of SARS-CoV-2 RNA in the plasma of asymptomatic blood donors during the pandemic peak and no evidence of infectivity in vivo and in vitro. The transfusion risk remains theoretical and does not justify the implementation of SARS-CoV-2 NAT for blood donations.

Le Cam S ，Gallian P ，Ricard C ，Narboux C ，Barlet V ，Maugard C ，Hauser L ，Brisbarre N ，Cappy P ，Pillonel J ，Laperche S ，Morel P ... -  《-》

No evidence of SARS-CoV-2 RNA among blood donors: A multicenter study in Hubei, China.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA could be detected in the blood of infected cases. From February 9, all blood establishments in Hubei province, China, implemented nucleic acid testing (NAT) for SARS-CoV-2 RNA among blood donors to ensure blood safety. Nucleic acid test screening individually (ID) or by minipool (MP) testing was performed according to the manufacturer's instructions. Inactivated culture supernatant of SARS-CoV-2-infected Vero cells was quantified by droplet digital polymerase chain reaction (ddPCR) and series diluted with negative plasma to evaluate the assay's performance. The limit of detection of the kit for MP testing was 62.94 and 33.14 copies/mL for N and ORF1ab region, respectively. ID testing could achieve 3.87 and 4.85 copies/mL for two regions using 1600 μL of plasma. Coefficients of variations of two different concentrations of reference samples were all less than 5% in MP testing. As of April 30, 2020, a total of 98,342 blood donations including 87,095 whole blood donations and 11,247 platelet donations were tested by ID or MP testing, and no RNAemia was found. In addition, Hubei province suffered precipitously decreased blood supply, especially in February: 86% reduction compared with the same period of 2019. Nucleic acid test screening of SARS-CoV-2 on blood donations is suitable in blood establishments using the commercial real-time PCR detection kit based on available instruments. The negative result indicated that SARS-CoV-2 appears to be no direct threat to blood safety but raises some serious issues for general blood supply.

Chang L ，Yan Y ，Zhao L ，Hu G ，Deng L ，Su D ，Peng D ，Nie X ，Wang S ，Li Y ，Wang J ，Ruan Z ，Gao S ，Yang H ，Guo F ，Wang L ... -  《-》

Investigational Testing for Zika Virus among U.S. Blood Donors.

Saá P ，Proctor M ，Foster G ，Krysztof D ，Winton C ，Linnen JM ，Gao K ，Brodsky JP ，Limberger RJ ，Dodd RY ，Stramer SL ... -  《-》

Risk of transfusion-transmitted infection with severe acute respiratory syndrome coronavirus 2 from blood donors in Japan.

Shinohara N ，Ito M ，Kai K ，Kamo N ，Owada T ，Sobata R ，Yamagishi N ，Takahashi H ，Ikeda Y ，Sawai H ，Furuta RA ，Matsubayashi K ，Hino I ，Goto N ，Satake M ... -  《-》