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

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

doi:10.1016/j.jcv.2023.105422

Cited by 2 publications

(2 citation statements)

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“…The sample size was calculated using the formula for comparing two independent proportions, which is used to estimate sample size for studies comparing the sensitivity and/or specificity of two tests of unpaired design. 5 Initially, NP swabs from children were delivered in a transport medium from each hospital. According to the manufacturer's instructions, RNA was prepared using prefilled kits and an automated nucleic acid purification instrument, MagNA Pure 96 (Roche, Switzerland).…”

Section: Methodsmentioning

confidence: 99%

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Saliva‐based Proteinase K method: A rapid and reliable diagnostic tool for the detection of SARS‐COV‐2 in children

Kim,

Park,

Hwang

et al. 2024

Journal of Medical Virology

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Early and accurate detection of viruses in children might help prevent transmission and severe diseases. In this study, the severe acute respiratory syndrome coronavirus 2 (SARS‐COV‐2) detection in children was evaluated using saliva specimens with a Proteinase K (PTK)‐based RNA preparation, as saliva collection is a simple and noninvasive procedure, even in young children, with fewer concerns about sample contamination. The saliva‐based PTK and the conventional paired nasopharyngeal aspiration (NPA)‐based detection methods were compared between COVID‐19‐positive and ‐negative children. In addition, the detection rate for SARS‐COV‐2 and the difference between admission and discharge by the saliva‐based PTK method was tested in COVID‐19 patients. The diagnostic accuracy of the saliva‐based PTK method was 98.8% compared to NP swab‐based reverse transcriptase polymerase chain reaction. Saliva samples showed high sensitivity (94.1%) and specificity (100%) when using the PTK method. Furthermore, the saliva‐based PTK method significantly reduced the test processing time by 2 h. Notably, Ct values at discharge increased in saliva samples compared with those at admission, which might indicate patients' clinical conditions or virus activity. In conclusion, the saliva‐based PTK implemented in this study streamlines RNA extraction, making the process faster, safer, and more cost‐effective, demonstrating that this method is a rapid and reliable diagnostic tool for SARS‐CoV‐2 detection in children.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%