tetano
Editor, Senior Moderator
Ann Clin Lab Sci
. 2024 Jan;54(1):126-130.
Communication: Evaluation of the Humasis COVID-19 Antigen Rapid Diagnostic Test for the Diagnosis of SARS-CoV-2 Infection
Eungjun Yoon[SUP] #[/SUP][SUP] 1 [/SUP], Minhee Kang[SUP] #[/SUP][SUP] 2 3 [/SUP], Hyang Jin Shim[SUP] 4 [/SUP], Suk-Jin Choi[SUP] 1 [/SUP], Mi-Ae Jang[SUP] 1 [/SUP], Ja-Hyun Jang[SUP] 1 [/SUP], Tae Yeul Kim[SUP] 5 [/SUP], Hee Jae Huh[SUP] 6 3 [/SUP], Nam Yong Lee[SUP] 1 [/SUP]
Affiliations
Objective: We assessed the performance of the Humasis COVID-19 AgHS Test (Humasis, Korea), a novel antigen rapid diagnostic test (Ag-RDT) based on lateral flow immunoassay.
Methods: 85 SARS-CoV-2-positive and 155 SARS-CoV-2-negative nasopharyngeal swab specimens confirmed by rRT-PCR were tested using the Humasis and PBCheck Ag-RDTs. The analytical specificity of the Humasis Ag-RDT was evaluated using 27 strains of human respiratory pathogens.
Results: The overall sensitivity and specificity were 72.9% and 99.4% for the Humasis Ag-RDT and 64.7% and 100% for the PBCheck Ag-RDT, respectively. The sensitivity for specimens with Ct≤25 was 100% for both Ag-RDTs. The Humasis Ag-RDT showed no cross-reactivity with other respiratory pathogens.
Conclusion: Our data suggests that the Humasis Ag-RDT can be a useful diagnostic tool for the detection of SARS-CoV-2 infection.
Keywords: COVID-19; Humasis; PBCheck; SARS-CoV-2; antigen rapid diagnostic test.
. 2024 Jan;54(1):126-130.
Communication: Evaluation of the Humasis COVID-19 Antigen Rapid Diagnostic Test for the Diagnosis of SARS-CoV-2 Infection
Eungjun Yoon[SUP] #[/SUP][SUP] 1 [/SUP], Minhee Kang[SUP] #[/SUP][SUP] 2 3 [/SUP], Hyang Jin Shim[SUP] 4 [/SUP], Suk-Jin Choi[SUP] 1 [/SUP], Mi-Ae Jang[SUP] 1 [/SUP], Ja-Hyun Jang[SUP] 1 [/SUP], Tae Yeul Kim[SUP] 5 [/SUP], Hee Jae Huh[SUP] 6 3 [/SUP], Nam Yong Lee[SUP] 1 [/SUP]
Affiliations
- PMID: 38514052
Objective: We assessed the performance of the Humasis COVID-19 AgHS Test (Humasis, Korea), a novel antigen rapid diagnostic test (Ag-RDT) based on lateral flow immunoassay.
Methods: 85 SARS-CoV-2-positive and 155 SARS-CoV-2-negative nasopharyngeal swab specimens confirmed by rRT-PCR were tested using the Humasis and PBCheck Ag-RDTs. The analytical specificity of the Humasis Ag-RDT was evaluated using 27 strains of human respiratory pathogens.
Results: The overall sensitivity and specificity were 72.9% and 99.4% for the Humasis Ag-RDT and 64.7% and 100% for the PBCheck Ag-RDT, respectively. The sensitivity for specimens with Ct≤25 was 100% for both Ag-RDTs. The Humasis Ag-RDT showed no cross-reactivity with other respiratory pathogens.
Conclusion: Our data suggests that the Humasis Ag-RDT can be a useful diagnostic tool for the detection of SARS-CoV-2 infection.
Keywords: COVID-19; Humasis; PBCheck; SARS-CoV-2; antigen rapid diagnostic test.