Immunoassay
Immunoassay
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Model NameRADI Influenza A/B Rapid TestInformationIM003Sample TypeNasopharyngeal swabsSensitivityInfluenza A : 95.0% vs. RT-PCR / Influenza B : 95.0% vs. RT-PCRSpecificityInfluenza A : 100.0% vs. RT-PCR / Influenza B : 100.0% vs. RT-PCRDetail
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Model NameRADI HCV Ab Rapid TestInformationIM004Sample Typehuman serum, plasma or whole bloodSensitivity98.6% vs. ECLIA TestSpecificity100.0% vs. ECLIA TestDetail -
Model NameRADI Flu-SC2 Ag Rapid TestInformationIM005
Sample TypeNasopharyngeal swabsSensitivitySARS-CoV-2 : 100.0 % vs. RT-PCR / Influenza A : 95.0% vs. RT-PCR / Influenza B : 95.0% vs. RT-PCRSpecificitySARS-CoV-2 : 100.0 % vs. RT-PCR / Influenza A : 100.0 % vs. RT-PCR / Influenza B : 100.0% vs. RT-PCRDetail -
Model NameRADI HBsAg Rapid TestInformationIM006Sample Typehuman serum, plasma or whole bloodSensitivity99.7% vs. RT-PCRSpecificity100.0% vs. RT-PCRDetail -
Model NameRADI Syphilis Ab Rapid TestInformationIM007Sample Typehuman serum, plasma or whole bloodSensitivity100.0% vs. RPR assaySpecificity100.0% vs. RPR assayDetail -
Model NameRADI Malaria P.f/Pan Ag Rapid TestInformationIM009Sample Typehuman whole bloodSensitivityP. Falciparum : 100.0% vs. PCR assay / P.vivax: 96.7% vs. PCR assaySpecificityP. Falciparum : 96.7% vs. PCR assay / P.vivax: 96.7% vs. PCR assayDetail -
Model NameRADI Dengue NS1 Ag Rapid TestInformationIM010Sample Typein human whole blood, serum, or plasmaSensitivity94.0 vs. RT-PCR assaySpecificity98.0 vs. RT-PCR assayDetail -
Model NameRADI Dengue IgG-IgM Rapid TestInformationIM011Sample Typehuman whole blood, serum, or plasmaSensitivityIgG : 98.1 vs. rRT-PCR assay / IgM : 96.7 vs. rRT-PCR assaySpecificityIgG : 96.0 vs. rRT-PCR assay / IgM : 98.0 vs. rRT-PCR assayDetail -
Model NameRADI Cholera Ag 01/0139 Rapid TestInformationIM012Sample Typehuman whole blood, serum, or plasmaSensitivityCholera Ag O1 : 96.7 vs. PCR assay / Cholera Ag O139 : 96.7 vs. PCR assaySpecificityCholera Ag O1 : 95.8 vs. PCR assay / Cholera Ag O139 : 95.0 vs. PCR assayDetail -
Model NameRADI Malaria P.f Ag Rapid TestInformationIM013Sample Typehuman whole bloodSensitivity100.0 vs. PCR assaySpecificity96.7 vs. PCR assayDetail -
Model NameRADI Malaria P.f/P.v Ag Rapid TestInformationIM014SensitivityP. Falciparum : 100.0% vs. PCR assay / P.vivax: 96.7% vs. PCR assaySpecificityP. Falciparum : 96.7% vs. PCR assay / P.vivax: 96.7% vs. PCR assayDetail -
Model NameRADI H.pylori Ag Rapid TestInformationIM015Sample Typehuman feces.Test Time15 MiniutesSensitivity94.3 % vs. ELISA assaySpecificity98.0 % vs. ELISA assayDetail -
Model NameRADI H.pylori Ab Rapid TestInformationIM016Sample Typein human serum, plasma and whole bloodTest Time15 MiniutesSensitivity98.9 % vs. ELISA assaySpecificity96.3 % vs. ELISA assayDetail -
Model NameRADI Mycoplasma Ag Rapid TestInformationIM017Sample Typehuman throat swabsSensitivity82.1 % vs. PCR assaySpecificity100.0 % vs. PCR assayDetail -
Model NameRADI Typoid IgG/IgM Ab Rapid TestInformationIM018Sample Typehuman serum, plasma or whole blood.SensitivityIgG : 99.0 % vs. ELISA assay / IgM : 98.1 % vs. ELISA assaySpecificityIgG : 98.3 % vs. ELISA assay / IgM : 98.8 % vs. ELISA assayDetail -
Model NameRADI LH Rapid TestInformationIM019Sample Typehuman serum, plasma or whole blood.Sensitivity100.0 % vs. ELISA assaySpecificity100.0 % vs. ELISA assayDetail -
Model NameRADI Monkeypox Ag Rapid TestInformationIM020Sample Typerash exudate or nasal swab. human serum, plasma or whole blood.Detail -
Model NameRADI HIV1/2 Ab Rapid TestInformationIM021Sample Typehuman serum, plasma or whole bloodTest Time15 MiniutesSensitivityHIV 1 : 100% vs CLIA / HIV2 : 96.67% vs CLIASpecificityHIV 1 : 99.0% vs CLIA / HIV2 : 99.0% vs CLIADetail -
Model NameRADI HCG Rapid TestInformationIM022Sample Typein human urineSensitivity95.0 vs. Clinical chemistrySpecificity100.0 vs. Clinical chemistryDetail -
Model NameRADI Dengue Combo Rapid TestInformationIM023Sample Typein human whole blood, serum, or plasmaSensitivityNS1 Ag : 94.0 vs. RT-PCR / IgG : 98.1 vs. rRT-PCR / IgM : 96.7 vs. rRT-PCRSpecificityNS1 Ag : 98.0 vs. RT-PCR / IgG : 96.0 vs. rRT-PCR / IgM : 98.0 vs. rRT-PCRDetail -
Model NameRADI Flu A/COVID-19/RSV Ag Rapid TestInformationIM024Sample TypeNasopharyngeal swabsTest Time15 MiniutesSensitivitySARS-CoV-2 : 97.3% vs RT-PCR / Influensza A : 100% vs RT-PCR / RSV : 97.8% vs RT-PCRSpecificitySARS-CoV-2 : 100% vs RT-PCR / Influensza A : 100% vs RT-PCR / RSV : 98.3% vs RT-PCRDetail -
Model NameRADI RSV Ag Rapid TestInformationIM025Sample TypeNasopharyngeal swabsTest Time15 MiniutesSensitivity97.8% vs. RT-PCRSpecificity98.3% vs. RT-PCRDetail -
Model NameRADI FOB Rapid TestInformationIM026Sample TypeHuman fecesTest Time15 MiniutesSensitivity98.0% vs. NS-Plus testSpecificity98.3% vs. NS-Plus testDetail