Evaluation of laboratory tests for COVID-19 in South Africa = Ukuhlaziya iZivivinyo zaseLabhorethri ze-COVID-19 eNingizimu Afrika

Abstract

The emergence of SARS-CoV-2 prompted urgent needs for accurate diagnosis, management, and containment strategies. This study evaluated diagnostic tests, including point-of-care (POC) tests, to aid in rapid diagnosis across different stages of COVID-19 in South Africa. A scoping review highlighted the variability in test performance, with no single assay achieving optimal sensitivity and specificity simultaneously. Sensitivity was influenced by the timing of sample collection, emphasizing the importance of early sampling. Rapid antigen tests were evaluated against RT-PCR, revealing reasonable sensitivity, especially in samples with lower Ct values and within the first week of symptom onset. However, performance varied across SARS-CoV-2 variants. Notably, PanbioTM and SD Biosensor tests maintained high sensitivity and specificity across different variants, including Omicron sub-lineages. Additionally, the study explored alternative sample types, such as saliva, finding comparable results to nasopharyngeal swabs. Serological tests were also assessed, with the Orient Gene Rapid test showing comparable performance to standard assays, while the MILLIPLEX® MAP Kit demonstrated higher detectability. Overall, despite extensive testing efforts, the sensitivity of diagnostic tests remained limited, underscoring the need for improved performance to effectively diagnose and manage SARS-CoV-2 infections and limit transmission. These findings provide valuable insights for enhancing testing strategies in South Africa and globally amidst evolving pandemic challenges.

Iqoqa.

Ukuqubuka kwe-SARS-CoV-2 kwaphusha izidingo eziphuthumayo zamasu okuhlonza isifo okuyikho, ukulawula nokunqanda. Lolu cwaningo lwahlola izivivinyo, okufaka nezivivinyo ezaziwa ngelepoint-of-care (POC), ukusiza ukuhlonza isifo ngokushesha ezigabeni ezehlukene ze-COVID-19 eNingizimu Afrika. Ukubuyekeza umumo kwagqamisa ukwehlukahlukana ekuhloleni ukusebenza, kungekho neyodwa i-asayi efikisa ekuzweleni okukhulu nasekuqondeni kanyekanye. Ukuzwela kwakudalwa yisikhathi sokuqoqwa kwesampula, kugcizelelwa ukubaluleka kokuqoqwa kwamasampula kwasekuqaleni. Izivivinyo eziningi zedalasihlungu zahlaziywa ziqhathaniswa ne-RT-PCR, okuveza ukuzwela okuzwakalayo, ikakhulukazi emasampuleni ane-Ct ephansi esontweni lokuqala lokubonakala kwezimpawu. Kodwa, ukusebenza kwehlukana ngokwezinhlobo ze-SARS-CoV-2. Okuqaphelekayo, yi-v Notably, PanbioTM nezivivinyo ze-SD Biosensor ezasimama ngokuzwela okukhulu namavariyenti ehlukene, okufaka nama-Omicron sub-lineages. Ukwengeza, ucwaningo lubheke ezinye izinhlobo zamasampula, njengamathe, ukuthola imiphumela eqhathaniseka nemisubelo yenasopharyngeal. Izivivinyo zeseroloji nazo zahlolwa, kanye nesivivinyo se-Orient Gene Rapid okukhombisa ukusebenza okuqhathanisekayo nama-asayi asezingeni, nakuba i-MILLIPLEX® MAP Kit yakhombisa ukutholakala ngezinga eliphezulu. Ngaphezu kwalokho, nakuba kunemizamo yokuhlola okunzulu, ubuthaka bezivivinyo eziyinhlonzasifo zazilokhu zincane, ukuthola okungaphansi isidingo sokusebenza okuphuculiwe ukuze kuhlonzwe ngendlela futhi kulawulwe ukutheleleka nge-SARS-CoV-2 bese kunqanda ukwedluliseka. Lokhu okutholakele kuhlinzeka imibono enesisindo ukuphucula amasu okuhlola eNingizimu Afrika nasemhlabeni jikelele ezinselelweni zobhubhane eziguquguqukayo.