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Clinical Trial
. 2023 May:162:105422.
doi: 10.1016/j.jcv.2023.105422. Epub 2023 Mar 3.

A multi-country phase 2 study to evaluate the suitcase lab for rapid detection of SARS-CoV-2 in seven Sub-Saharan African countries: Lessons from the field

Arianna Ceruti  1 , Ndongo Dia  2 , Adeleye Solomon Bakarey  3 , Judah Ssekitoleko  4 , Soa Fy Andriamandimby  5 , Padra Malwengo-Kasongo  6 , Rasheeda H A Ahmed  7 , Rea Maja Kobialka  8 , Jean Michel Heraud  2 , Moussa Moise Diagne  2 , Marie Henriette Dior Dione  2 , Idrissa Dieng  2 , Martin Faye  2 , Ousmane Faye  2 , Jean Théophile Rafisandratantsoa  5 , Jean-Pierre Ravalohery  5 , Claudio Raharinandrasana  5 , Tsiry H Randriambolamanantsoa  5 , Norosoa Razanajatovo  5 , Iony Razanatovo  5 , Joelinotahina H Rabarison  5 , Phillipe Dussart  5 , Louis Kyei-Tuffuor  9 , Abigail Agbanyo  9 , Olubusuyi Moses Adewumi  10 , Adeola Fowotade  11 , Muideen Kolawole Raifu  3 , Patient Okitale-Talunda  6 , Gracia Kashitu-Mujinga  6 , Christelle Mbelu-Kabongo  6 , Steve Ahuka-Mundeke  6 , Anguy Makaka-Mutondo  6 , Enas M Abdalla  12 , Sanaa M Idris  12 , Wisal A Elmagzoub  12 , Rahma H Ali  7 , Eman O M Nour  7 , Rasha S M Ebraheem  7 , Huda H H Ahmed  7 , Hamadelniel E Abdalla  7 , Musab Elnegoumi  7 , Izdihar Mukhtar  7 , Muatsim A M Adam  7 , Nuha Y I Mohamed  7 , Shahinaz A Bedri  7 , Hamdan Mustafa Hamdan  13 , Magid Kisekka  4 , Monica Mpumwiire  4 , Sharley Melissa Aloyo  14 , Joanita Nabwire Wandera  14 , Andrew Agaba  14 , Rogers Kamulegeya  14 , Hosea Kiprotich  14 , David Patrick Kateete  14 , Paul Kadetz  15 , Uwe Truyen  8 , Kamal H Eltom  12 , Anavaj Sakuntabhai  16 , Julius Boniface Okuni  4 , Sheila Makiala-Mandanda  6 , Vincent Lacoste  5 , George Olusegun Ademowo  3 , Michael Frimpong  17 , Amadou Alpha Sall  2 , Manfred Weidmann  18 , Ahmed Abd El Wahed  8
Affiliations
Clinical Trial

A multi-country phase 2 study to evaluate the suitcase lab for rapid detection of SARS-CoV-2 in seven Sub-Saharan African countries: Lessons from the field

Arianna Ceruti et al. J Clin Virol. 2023 May.

Abstract

Background: The COVID-19 pandemic led to severe health systems collapse, as well as logistics and supply delivery shortages across sectors. Delivery of PCR related healthcare supplies continue to be hindered. There is the need for a rapid and accessible SARS-CoV-2 molecular detection method in low resource settings.

Objectives: To validate a novel isothermal amplification method for rapid detection of SARS-CoV-2 across seven sub-Sharan African countries.

Study design: In this multi-country phase 2 diagnostic study, 3,231 clinical samples in seven African sites were tested with two reverse transcription Recombinase-Aided Amplification (RT-RAA) assays (based on SARS-CoV-2 Nucleocapsid (N) gene and RNA-dependent RNA polymerase (RdRP) gene). The test was performed in a mobile suitcase laboratory within 15 min. All results were compared to a real-time RT-PCR assay. Extraction kits based on silica gel or magnetic beads were applied.

Results: Four sites demonstrated good to excellent agreement, while three sites showed fair to moderate results. The RdRP gene assay exhibited an overall PPV of 0.92 and a NPV of 0.88. The N gene assay exhibited an overall PPV of 0.93 and a NPV 0.88. The sensitivity of both RT-RAA assays varied depending on the sample Ct values. When comparing sensitivity between sites, values differed considerably. For high viral load samples, the RT-RAA assay sensitivity ranges were between 60.5 and 100% (RdRP assay) and 25 and 98.6 (N assay).

Conclusion: Overall, the RdRP based RT-RAA test showed the best assay accuracy. This study highlights the challenges of implementing rapid molecular assays in field conditions. Factors that are important for successful deployment across countries include the implementation of standardized operation procedures, in-person continuous training for staff, and enhanced quality control measures.

Keywords: Diagnostics-in-a-suitcase; Recombinase polymerase amplification assay; SARS-CoV-2.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig 1
Fig. 1
Schematic representation of the multi-country, single blinded, phase 2 study to test archived samples with the RT-RAA assay for SARS-CoV-2. Institut Pasteur de Dakar (IPD); Institut Pasteur de Madagascar (IPM); Kumasi Centre for Collaborative Research (KCCR); University of Ibadan (UI); Institut National de Recherche Biomédicale (INRB); University of Khartoum (UofK); and Makerere University (MAK).
Fig 2
Fig. 2
Workflow of the performed tests at the study sites. The new real-time RT-PCR performed was used as the reference method to validate the RT-RAA assays.
Fig 3
Fig. 3
Example of the suitcase lab, which is fully equipped to perform molecular tests in the field.
Fig 4
Fig. 4
The suitcase lab at various study sites.
See this image and copyright information in PMC

References

    1. Organization, W.H. WHO announces COVID-19 outbreak a pandemic. 2020.
    1. Rai P., Kumar B.K., Deekshit V.K., Karunasagar I. Detection technologies and recent developments in the diagnosis of COVID-19 infection. Appl. Microbiol. Biotechnol. 2021;105:441–455. doi: 10.1007/s00253-020-11061-5. - DOI - PMC - PubMed
    1. Zhu G., Chou M.C., Tsai C.W. Lessons learned from the COVID-19 pandemic exposing the shortcomings of current supply chain operations: a long-term prescriptive offering. Sustainability. 2020;12:5858.
    1. Iyengar K.P., Vaishya R., Bahl S., Vaish A. Impact of the coronavirus pandemic on the supply chain in healthcare. British J. Healthcare Manag. 2020;26:1–4.
    1. Organization W.H. World Health Organization; 2021. Antigen-Detection in the Diagnosis of SARS-CoV-2 Infection: Interim Guidance, 6 October 2021.

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