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孟加拉国化学计量参考研究所生产的新型冠状病毒2型病毒运输培养基的性能评估

Performance Evaluation of SARS-CoV-2 Viral Transport Medium Produced by Bangladesh Reference Institute for Chemical Measurements.

作者信息

Razu Mamudul Hasan, Monir Bayzid Bin, Moniruzzaman Md, Sarkar Sawgotom, Akhter Sonia, Kamal Sabiha, Hasan Md Abu, Afroze Mirola, Imam Khandaker Md Sharif Uddin, Khan Mala

机构信息

Bangladesh Reference Institute for Chemical Measurements (BRICM), Dr. Qudrat-E-Khuda Road, Dhanmondi, Dhaka 1205, Bangladesh.

National Institute of Laboratory Medicine and Referral Center (NILMRC), Sher-E-Bangla Nagar, Agargoan, Dhaka 1207, Bangladesh.

出版信息

Diagnostics (Basel). 2023 May 4;13(9):1622. doi: 10.3390/diagnostics13091622.

DOI:10.3390/diagnostics13091622
PMID:37175013
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10177798/
Abstract

A viral transport medium (VTM) was developed following the Centers for Disease Control and Prevention, USA (US-CDC) standard operating procedure (SOP) DSR-052-05 with necessary improvisation and was used for storing coronavirus disease 2019 (COVID-19) swab specimens. Considering Bangladesh's supply chain and storage conditions, improvisation was essential for extending sample storage time while retaining efficiency. In-house VTM was produced using Hank's balanced salt solution (HBSS) supplemented with 1% bovine serum albumin V (BSA), 0.5 µg /mL of gentamicin sulfate, and 100 µg/mL of fluconazole. The produced VTM composition, quality, sterility, specificity, and efficiency were verified in-house and through an independent contract research organization (CRO). An accelerated stability study projected that under the recommended temperature (4 °C), it would remain stable for four months and preserve samples for over a month. The real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) test detected the targeted gene and gene from the VTM stored samples. Our VTM is equally as effective as the Sansure Biotech VTM in keeping SARS-CoV-2 RNA specimens detectable in rRT-PCR (100% sensitivity and specificity in random and blinded samples). In conclusion, the BRiCM VTM will make the battle against pandemics easier by effectively collecting and storing nasopharyngeal and oropharyngeal swabs for COVID-19 detection.

摘要

一种病毒运输培养基(VTM)是按照美国疾病控制与预防中心(US-CDC)的标准操作程序(SOP)DSR-052-05,并进行必要的改进后研制而成,用于储存2019冠状病毒病(COVID-19)的拭子样本。考虑到孟加拉国的供应链和储存条件,改进对于延长样本储存时间并保持效率至关重要。内部VTM是使用补充了1%牛血清白蛋白V(BSA)、0.5μg/mL硫酸庆大霉素和100μg/mL氟康唑的汉克平衡盐溶液(HBSS)制备的。所生产的VTM的成分、质量、无菌性、特异性和效率在内部以及通过独立的合同研究组织(CRO)进行了验证。一项加速稳定性研究预计,在推荐温度(4℃)下,它将保持稳定四个月,并能保存样本一个多月。实时逆转录聚合酶链反应(rRT-PCR)检测从VTM储存样本中检测到了目标基因。我们的VTM在使rRT-PCR中SARS-CoV-2 RNA样本可检测方面与圣湘生物科技的VTM同样有效(随机和盲法样本中的灵敏度和特异性均为100%)。总之,BRiCM VTM将通过有效收集和储存用于COVID-19检测的鼻咽和口咽拭子,使抗击大流行的战斗更加轻松。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fd5/10177798/2adca2b29fc5/diagnostics-13-01622-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fd5/10177798/7f06e3623a55/diagnostics-13-01622-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fd5/10177798/f62150bf7ff7/diagnostics-13-01622-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fd5/10177798/2adca2b29fc5/diagnostics-13-01622-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fd5/10177798/7f06e3623a55/diagnostics-13-01622-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fd5/10177798/f62150bf7ff7/diagnostics-13-01622-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fd5/10177798/2adca2b29fc5/diagnostics-13-01622-g003.jpg

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The COVID-19 Pandemic-an Epidemiological Perspective.新型冠状病毒肺炎大流行的流行病学视角。
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