No evidence of <scp>SARS‐CoV</scp>‐2 <scp>RNA</scp> among blood donors: A multicenter study in Hubei, China

Chang, Le; Yan, Ying; Zhao, Lei; Hu, Guibin; Deng, Lijuan; Su, Dan; Peng, Dongju; Nie, Xinjiao; Wang, Song; Li, Yuanyuan; Wang, Jundao; Zhong, Ruan; Gao, Shouliang; Yang, Huasong; Guo, Fei; Wang, Lunan

doi:10.1111/trf.15943

Cited by 27 publications

(47 citation statements)

References 24 publications

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“…It will also be important to determine if quantification of SARS-CoV-2 RNA level in plasma and serum by CRISPR-ABC has utility for the rapid evaluation of COVID-19 prognosis, progression, and treatment response.Finally, while the existence of secondary infection sites suggests that SARS-CoV-2 can spread through the circulation, it is unknown what fraction of SARS-CoV-2 RNA detected by our assay is present in replication-competent virions; whether this amount changes during disease development, or with infection severity; and how long it persists after diagnosis. This may have implications for the screening of blood donations,given rare instances of detectable viral RNA in blood from asymptomatic or pre-symptomatic individuals during a local outbreak but not after disease containment(45,46). However, it is not clear if this RNA is indicative of infectious virus, or if such virus might be present at levels sufficient to promote an infection, or would survive normal blood processing and storage procedures.…”

mentioning

confidence: 99%

Sensitive tracking of circulating viral RNA through all stages of SARS-CoV-2 infection

Huang¹,

Ning²,

Yang³

et al. 2021

Journal of Clinical Investigation

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Background: Circulating SARS-CoV-2 RNA may represent a more reliable indicator of infection than nasal RNA, but RT-qPCR lacks diagnostic sensitivity for blood samples. Methods: A CRISPR-augmented RT-PCR assay that sensitively detects SARS-CoV-2 RNA was employed to analyze viral RNA kinetics in longitudinal plasma samples from nonhuman primates (NHP) after virus exposure; to evaluate the utility of blood SARS-CoV-2 RNA detection for COVID-19 diagnosis in adults cases confirmed by nasal/nasopharyngeal swab RT-PCR results; and to identify suspected COVID-19 cases in pediatric and at-risk adult populations with negative nasal swab RT-qPCR results. All blood samples were analyzed by RT-qPCR to allow direct comparisons. Results: CRISPR-augmented RT-PCR consistently detected SARS-CoV-2 RNA in the plasma of experimentally infected NHPs from 1 to 28 days post-infection, and these increases preceded and correlated with rectal swab viral RNA increases. In a patient cohort (n=159), this blood-based assay demonstrated 91.2% diagnostic sensitivity and 99.2% diagnostic specificity versus a comparator RT-qPCR nasal/nasopharyngeal test, while RT-qPCR exhibited 44.1% diagnostic sensitivity and 100% specificity for the same blood samples. This CRISPR-augmented RT-PCR assay also accurately identified COVID-19 patients with one or more negative nasal swab RT-qPCR result. Conclusion: Results of this study indicate that sensitive detection of SARS-CoV-2 RNA in blood by CRISPR-augmented RT-PCR permits accurate COVID-19 diagnosis, and can detect COVID-19 cases with transient or negative nasal swab RT-qPCR results, suggesting that this approach could improve COVID-19 diagnosis and the evaluation of SARS-CoV-2 infection clearance, and predict the severity of infection.

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mentioning

confidence: 99%

Sensitive tracking of circulating viral RNA through all stages of SARS-CoV-2 infection

Huang¹,

Ning²,

Yang³

et al. 2021

Journal of Clinical Investigation

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“…In a study at the Wuhan Blood Center, four positive blood donations with high Ct values for SARS‐CoV‐2 RNA above 34 were identified 5 . The subsequent multicenter study in Hubei (China) tested more than 98 000 blood donations negative for SARS‐CoV‐2 RNA 6 . The majority of donor screening was performed by pooled‐sample testing (minipool with eight samples) with a decreased sensitivity (LOD95, 62.94 copies/mL) compared to single‐sample testing (LOD95, 3.87 copies/mL) for the N region 6 .…”

Section: Discussionmentioning

confidence: 99%

“…The subsequent multicenter study in Hubei (China) tested more than 98 000 blood donations negative for SARS‐CoV‐2 RNA 6 . The majority of donor screening was performed by pooled‐sample testing (minipool with eight samples) with a decreased sensitivity (LOD95, 62.94 copies/mL) compared to single‐sample testing (LOD95, 3.87 copies/mL) for the N region 6 . The higher frequency of SARS‐CoV‐2 RNA detection in the study of the Wuhan Blood Center could be related to differences in the sensitivity of pooled‐sample testing and in the time period of donation testing, which was performed closer to height of the outbreak of SARS‐CoV‐2 in Wuhan compared to the multicenter study in Hubei province 13 .…”

Section: Discussionmentioning

confidence: 99%

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Validation of a SARS‐CoV‐2 RNA RT‐PCR assay for high‐throughput testing in blood of COVID‐19 convalescent plasma donors and patients

et al. 2020

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Background The frequency of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) RNAemia in blood donors is uncertain. Thus, assays for SARS‐CoV‐2 RNA detection in blood, validated on commercially available polymerase chain reaction (PCR) systems, are required to allow a good comparability of data. Study Design and Methods The cobas SARS‐CoV‐2 dual‐target reverse transcriptase PCR (RT‐PCR) assay, licensed for respiratory swab SARS‐CoV‐2 RNA testing, was validated for detection of viral RNA in blood. For the validation panel, SARS‐CoV‐2–positive plasma samples were prepared by spiking SARS‐CoV‐2–positive respiratory specimens in negative human plasma. The 95% limit of detection (LOD95) was determined by probit analysis. For clinical validation, coronavirus disease 2019 (COVID‐19) convalescent plasma (CCP) donors and patients with COVID‐19 with a severe disease course treated in an intensive care unit (ICU) were included. Results The validation of the SARS‐CoV‐2 RT‐PCR assay for blood demonstrated high sensitivity and specificity and intra‐ and inter‐assay precision and efficiency. The LOD95 for SARS‐CoV‐2 RNA was 5.0 genome copies/mL (95% confidence interval [CI], 3.3‐12 copies/mL) for target 1 and 4.3 genome copies/mL (95% CI, 2.9‐10 copies/mL) for target 2. In a cohort of 39 CCP donors with 66 CCP donations no SARS‐CoV‐2 RNA in plasma was detected. Screening of 25 blood samples of 19 ICU patients with COVID‐19 showed six positive results for SARS‐CoV‐2 RNA in at least one target of the assay. Conclusion The SARS‐CoV‐2 RNA assay, only licensed for respiratory swabs, performed on a PCR system for high‐throughput testing, showed a good assay performance for blood testing.

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“…In all cases, RNA was present at low levels and infectious virus was not confirmed [144]. A subsequent report of SARS‐CoV‐2 RNA screening of 94 342 blood donations in Hubei Province between 9 February and 30 April 2020 found no RNA‐positive donations [145]. However, it was noted that this testing period was immediately after the height of the COVID‐19 outbreak in Hubei.…”

Section: Implications For Safety and Sufficiency Of The Blood Supplymentioning

confidence: 99%

Severe acute respiratory syndrome coronavirus‐2: implications for blood safety and sufficiency

et al. 2020

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Background and Objective Severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) is a novel coronavirus, first identified in China at the end of 2019 and has now caused a worldwide pandemic. In this review, we provide an overview of the implications of SARS‐CoV‐2 for blood safety and sufficiency. Material and Method We searched the PubMed database, the preprint sites bioRxiv and medRxiv, the websites of the World Health Organization, European Centre for Disease Prevention and Control, the US Communicable Diseases Center and monitored ProMed updates. Results An estimated 15%–46% of SARS‐CoV‐2 infections are asymptomatic. The reported mean incubation period is 3 to 7 days with a range of 1–14 days. The blood phase of SARS‐CoV‐2 appears to be brief and low level, with RNAaemia detectable in only a small proportion of patients, typically associated with more severe disease and not demonstrated to be infectious virus. An asymptomatic blood phase has not been demonstrated. Given these characteristics of SARS‐CoV‐2 infection and the absence of reported transfusion transmission (TT), the TT risk is currently theoretical. To mitigate any potential TT risk, but more importantly to prevent respiratory transmission in donor centres, blood centres can implement donor deferral policies based on travel, disease status or potential risk of exposure. Conclusion The TT risk of SARS‐CoV‐2 appears to be low. The biggest risk to blood services in the current COVID‐19 pandemic is to maintain the sufficiency of the blood supply while minimizing respiratory transmission of SARS‐CoV‐19 to donors and staff while donating blood.

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

Cited by 27 publications

References 24 publications

Sensitive tracking of circulating viral RNA through all stages of SARS-CoV-2 infection

Sensitive tracking of circulating viral RNA through all stages of SARS-CoV-2 infection

Validation of a SARS‐CoV‐2 RNA RT‐PCR assay for high‐throughput testing in blood of COVID‐19 convalescent plasma donors and patients

Severe acute respiratory syndrome coronavirus‐2: implications for blood safety and sufficiency

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