Coronavirus (SARS-COV-2)Antigen Rapid Test Kit

Antigen Rapid Test Kit
l)25 Indvidul sealed pouches,each pouch
1*Desiccant Pouch
25 Sampling Tubes(Containing Sample ExtracionLiquid) 25 Sterile Swabs 25 Biosafety Bag
The Novel Coromvins (SARS-CoV-2)Antigen Rapid Tes Kit is a chromatographic immunassay intended fr the qualitaive detecion of the nucleocapid protein antigen fom SARS-CoV-2 in nasopharyngeal swab ororopharyngealswab specimens direcly fomindividuals who are suspcted of COVID-19 by their healthcare provider within the first 7 days of symptom onset.
Materials Required But Not Provided) Clock,timer,orstopwatch KoSTa1
preclude SARSCoV-2 infection and they cano be usedas the sole basis for tratment r other management deision. For in vitro diagnostic use ony.
)Stored at 4～30℃ protected fiom light.) Properly stored kitsare valid for 12months.
The testcardshould beused within l hour afte tkingout fom the packaging bag,
The novel coronaviruses belong to theβgenus.COVID-19 is an acute respiratory ifectious disease.People are generally susceptible. of infecion; asymptomatic ifected people can also be an infectious source.
The testcan be taken wih nasopharyngeal swabor oropharyngeal swab .Nasopharyngel swab specimen colletionCareflly insert the swab gently push the swab itothe posterior nasopharynx.Rotate the swab several times over the surface of the posterior masopharynx,then withdraw the swab from the nasal cavity.
Based on the currnt epidemiological investigation, the incubation fever,fatigue and dry cough. Nasal congestion,rumy nose,sore throat myalgia and diarhea aefound ina few cases.
propharyngeal swab specimen colection: Insert swab into the posteriorpharynxand tonslla areas.Rubswab over both tonilla pilars and posteriororopharynxand avoid touchingthetongue,teh and gums. 3.It isrecommendedthat the specimen istestedat hetime ofspecimen storedat2~8℃ forupto4hous,or theymaybe storedat-70℃fora long time.
The Novel Coronavirus(SARSCoV-2)Antigen Rapid Test Kit is composed of povel Coronavirus monclonal antibody 2and gat antia mouse IgG polylonal antibody ixed in thenitroclulose membrane and release padThe kt tests Novel Coronavirus SARS-CoV-2 N antigen in human nasopharyngeal swabs or oropharyngeal swabs with the principle of doubleantibod sandwidh method bylatex immunochronmatography. When a specimen is add to the sample wel, the sample is frst atibody I on the relase pad,and then migrte on the nirocllulose membrane.If SARS-CoV-2 N protein antigen presents in te sample, these antigens wll bind to coromavius monodonal antibody 1 labeled migrates through nitrocellose membrane by capllary acdion.When the complex is capured by the SARS-CoV-2 monoclonal antibody 2tofom a red colored band in the T line, which is a positive resultIf no antigen presents in the sample,there will be no red band aparing in thetesting region,this isa negative reult.The intemal controlC band ixing with
4.The samples andthe kitshould beretumed to rom temperature before Specimen Transprt and Storage
·Collet sample as soon as possbleafte onsetofsymptoms.· Test sample immediately.
·Use onlyswabs provided with thekit.
·Refer to: Interim Guidelinesfor Collecting, Handling and Testing htps/www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical- specimens.html
2.Shake the sampling tube fr sevealtimesand makesure tat tesample is fillydissolved in the sample extration iquid. 3.Take out a test card from the packaging bagby taringa the mthand place it on a level surface.
4.Unsrew theupper crew cap and ad2 drosof iquid to"SY(the
sample well).
5.Wait fr 15-20 minuesandread hereuls.Do no readresulsafer 20 . Afer the est,pt the medicalwastes inothebiosafey bag)NOTE:Do notuse sampltbe fom anyohr podut inelding aher products fom Jinwofu o other manufcturer
This it IS NOT INTENDED or esting iqudsamples ucha aspiate samples or swabs intransport medias esults ca be compromised by over dlutin. Interpretation ofRezut Positive Result
ans The peset ofred badinconrd C and T.Iidictes tat her s
SARS-CoV-2 antign in specimen Negative rsult
indicates that the concentration of the SARS-CoV-2 atigen is zero or below the dection limit ofthe kit
Control line fails to appear.Insufficient sample volume or incorect procedural techniques are the most likely reasons for control line ailure.
O-
Freshhy collectedspecimensshould be tested within I hour