Impaired performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests at elevated and low temperatures

Version published to 10.1016/j.jcv.2021.104796

May 1, 2021

SciScore for 10.1101/2021.02.01.21250904: (What is this?)

Please note, not all rigor criteria are appropriate for all manuscripts.

Table 1: Rigor

Institutional Review Board Statement	not detected.
Randomization	not detected.
Blinding	not detected.
Power Analysis	not detected.
Sex as a biological variable	not detected.

Table 2: Resources

No key resources detected.

Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

Results from TrialIdentifier: No clinical trial numbers were referenced.

Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

Results from JetFighter: We did not find any issues relating to colormaps.

Results from rtransparent:

Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
No protocol registration statement was detected.

Read the original source

SciScore for 10.1101/2021.01.06.21249314: (What is this?)

Please note, not all rigor criteria are appropriate for all manuscripts.

Table 1: Rigor

Institutional Review Board Statement	not detected.
Randomization	not detected.
Blinding	not detected.
Power Analysis	not detected.
Sex as a biological variable	not detected.
Cell Line Authentication	not detected.

Table 2: Resources

Experimental Models: Cell Lines
Sentences	Resources
After application of SARS-CoV-2, HCoV-229E or HCoV-OC43 cell culture supernatant in a biological safety cabinet, Ag-RDTs were further incubated in a 37°C incubator until readout of the results.	HCoV-OC43 suggested: None
Analytical sensitivity: SARS-CoV-2 (BetaCoV/Munich/ChVir984/2020) was grown on Vero E6 cells (C1008; African green monkey kidney cells) and maintained in DMEM containing 10% FCS at 37°C with 5% CO2.	Vero E6 suggested: …

SciScore for 10.1101/2021.01.06.21249314: (What is this?)

Please note, not all rigor criteria are appropriate for all manuscripts.

Table 1: Rigor

Institutional Review Board Statement	not detected.
Randomization	not detected.
Blinding	not detected.
Power Analysis	not detected.
Sex as a biological variable	not detected.
Cell Line Authentication	not detected.

Table 2: Resources

Experimental Models: Cell Lines
Sentences	Resources
After application of SARS-CoV-2, HCoV-229E or HCoV-OC43 cell culture supernatant in a biological safety cabinet, Ag-RDTs were further incubated in a 37°C incubator until readout of the results.	HCoV-OC43 suggested: None
Analytical sensitivity: SARS-CoV-2 (BetaCoV/Munich/ChVir984/2020) was grown on Vero E6 cells (C1008; African green monkey kidney cells) and maintained in DMEM containing 10% FCS at 37°C with 5% CO2.	Vero E6 suggested: RRID:CVCL_XD71)
Analytical specificity: Specificity was tested using cell culture supernatant of HCoV-229E and HCoV-OC43, grown on CaCo-2 cells.	CaCo-2 suggested: CLS Cat# 300137/p1665_CaCo-2, RRID:CVCL_0025)
Software and Algorithms
Sentences	Resources
Data on COVID-19 cases were obtained from Worldmeter (20) and visualized using the GraphPad Prism software.	GraphPad Prism suggested: (GraphPad Prism, RRID:SCR_002798)

Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

An additional limitation of our study is the use of duplicates for some tests instead of a higher number of replicates, which was due to the limited availability of all tests included in the study. Further studies will be required to assess test performance upon tropical storage and application in tropical conditions using large numbers of clinical samples. Additionally, not only the effect of elevated temperature but also the effect of increased humidity on test performance will have to be assessed. Finally, future studies documenting the impact of decreased temperature on test performance may also be needed. Despite these limitations, our study presents a robust resource for further validation studies as a high number of SARS-CoV-2 Ag-RDTs was included. Additionally, our data on an overall impaired performance of Ag-RDTs at elevated temperatures are consistent across tests and analytical sensitivity for several tests was identical upon usage of either duplicates or higher numbers of replicates. In sum, it was shown previously that clinically relevant virus concentrations of about 106 genome copies per ml suffice for virus isolation and culture and therefore serve as a correlate for infectivity (35, 36). Our study strongly suggests that short- and long-term exposure to elevated temperatures may compromise sensitivity of SARS-CoV-2 Ag-RDTs to an extent that may lead to false-negative test results at clinically relevant virus concentrations, potentially enhancing SARS-CoV-2 sp...

Results from TrialIdentifier: No clinical trial numbers were referenced.

Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

Results from JetFighter: We did not find any issues relating to colormaps.

Results from rtransparent:

Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
No protocol registration statement was detected.

Read the original source

Impaired performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests at elevated and low temperatures

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