COVID-19 Ag Rapid Saliva Test Device is a rapid chromatographic immunoassay for the qualitative detection of speciﬁc antigens from SARS-CoV-2 present in human saliva within the first 7 days of symptom onset. This test is for professional used only, as an aid to earlydiagnosisofSARS-CoV-2infectioninpatient. The result of this test should not be the sole basis for the diagnosis; conﬁrmatorytestingisrequired.
The COVID-19 Ag Rapid Saliva Test Device uses double antibody sandwich immunoassay. The NC membrane pre-immobilized with monoclonal antibodies against SARS-CoV-2 antigen and anti-mouse polyclonal antibodies, and the colloidal-gold conjugated with monoclonal antibodies specific to SARS-CoV-2 antigen. If SARS-CoV-2 antigen present in the sample, a complex formed between the anti-SARS-CoV-2 conjugate and the antigen will be caught by the specific anti- SARS-CoV-2 monoclonal coated on the T region. Results appear in 10 to 20 minutes in the form of a red line thatdevelopsonthestrip. Whether the sample contains the SARS-CoV-2 antigen or not, the solution continues to migrate to encounter another reagent (an anti-mouseIgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C.
KitContent 1).Testdevice(individuallypacked inafoilpouch). 2).Extractionbuffervial. 3).Salivaswab. 4).Instructionforuse.
PerformanceCharacteristics ClinicalEvaluation Clinicalevaluationwasperformedtocomparetheresultsobtainedby COVID-19AgRapidTestDeviceandPCR.Theresultswere summarizedbelow: Table:COVIDAgRapidTestDevicevs.PCR COVIDAgRapidTestDevice Total Result+ PCR + 34 1 35 - 0 200 200 TotalResults 34 201 235 Relativesensitivity:34/35=97.1%(95%CI85.47%~99.49%) Relativespecificity:200/200>99%(95%CI98.12%~100%) Overallagreement:(34+200)/(34+0+1+200)*100%=99.57%(95%CI 97.63%~99.92%) CI:ConfidenceInterval
Copyright © Jiangsu Well Biotech Co., Ltd. All Rights Reserved. | Sitemap | Powered by