COVID-19 Antigen Rapid Test Cassette (Colloidal Kub)

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Product Detail

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YUAV TSUM SIV

Qhov COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) yog lateral flow immunoassay npaj rau kev kuaj pom zoo SARS-CoV-2 nucleocapsid antigens hauv qhov ntswg swab los ntawm cov tib neeg uas xav tias yog COVID-19 los ntawm lawv tus kws kho mob.

Cov txiaj ntsig yog rau kev txheeb xyuas ntawm SARS-CoV-2 nucleocapsid antigen.Antigen feem ntau pom tau hauv qhov ntswg qhov ntswg thaum lub sij hawm mob hnyav.Cov txiaj ntsig zoo qhia tau tias muaj cov kab mob antigens, tab sis kev sib raug zoo nrog cov neeg mob keeb kwm thiab lwm cov ntaub ntawv kuaj mob yog tsim nyog los txiav txim seb tus kab mob.Cov txiaj ntsig zoo tsis txwv kev kis kab mob lossis kev sib koom ua ke nrog lwm cov kab mob.Tus neeg sawv cev kuaj pom yuav tsis yog qhov ua rau muaj kab mob.

Cov txiaj ntsig tsis zoo tsis txiav txim rau tus kab mob SARS-CoV-2 thiab yuav tsum tsis txhob siv los ua lub hauv paus rau kev kho mob lossis kev txiav txim siab tswj tus neeg mob, suav nrog kev txiav txim siab tswj kev kis kab mob.Cov txiaj ntsig tsis zoo yuav tsum raug txiav txim siab nyob rau hauv cov ntsiab lus ntawm tus neeg mob qhov tshwm sim tsis ntev los no, keeb kwm thiab muaj cov tsos mob thiab cov tsos mob zoo ib yam nrog COVID-19, thiab tau lees paub nrog kev ntsuam xyuas molecular, yog tias tsim nyog rau kev tswj hwm tus neeg mob.Cov khoom siv no yog siv rau hauv tsev los ntawm cov neeg ua haujlwm hauv qhov chaw tsis muaj chaw kuaj (xws li tus neeg lub tsev lossis qee qhov chaw tsis yog ib txwm muaj xws li chaw ua haujlwm, kev sib tw kis las, tsev kawm ntawv thiab lwm yam).Cov txiaj ntsig ntawm cov khoom siv no tsuas yog siv rau kev kho mob nkaus xwb.Nws raug nquahu kom ua qhov kev ntsuam xyuas dav dav ntawm tus mob raws li cov neeg mob kev kuaj mob thiab lwm yam kev kuaj mob.

TSEEM CEEB

Novel coronaviruses (SARS-CoV-2) belongs to the β genus.COVID-19 yog tus kab mob ua pa hnyav heev.Tib neeg feem ntau raug mob.Tam sim no, cov neeg mob kis los ntawm tus kabmob tshiab no yog qhov tseem ceeb ntawm kev kis tus kabmob;Cov neeg mob asymptomatic kuj tuaj yeem yog qhov kis tau.Raws li kev tshawb nrhiav kev kis kabmob tam sim no, lub sijhawm incubation yog 1 txog 14 hnub, feem ntau yog 3 txog 7 hnub.Cov tsos mob tseem ceeb muaj xws li kub taub hau, qaug zog thiab hnoos qhuav.Qhov ntswg congestion, los ntswg qhov ntswg, mob caj pas, myalgia thiab raws plab yog pom nyob rau hauv ob peb kis.

PRINCIPLE

Tus Kab Mob Khaus Viv-19 Antigen Rapid Test Cassette (Nasal Swab) yog ib qho lateral flow immunoassay raws li lub hauv paus ntsiab lus ntawm ob-antibody sandwich txheej txheem.SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugat-ed nrog cov xim microparticles yog siv los ua tus ntes thiab txau rau ntawm cov ntaub ntawv sib txuas.Thaum lub sijhawm kuaj, SARS-CoV-2 antigen hauv cov qauv cuam tshuam nrog SARS-CoV-2 antibody conjugated nrog cov xim microparticles ua antigen-antibody labeled complex.Qhov no complex migrates ntawm daim nyias nyias ntawm capillary kev txiav txim mus txog rau thaum lub xeem kab, qhov uas nws yuav raug ntes los ntawm pre-coat- SARS-CoV-2 nucleocapsid protein monoclonal antibody.Ib kab kuaj xim (T) yuav pom nyob rau hauv lub qhov rais tshwm sim yog SARS-CoV-2 antigens muaj nyob rau hauv cov qauv.Kev tsis muaj T kab qhia pom qhov tshwm sim tsis zoo.Cov kab tswj (C) yog siv rau kev tswj cov txheej txheem, thiab yuav tsum ib txwm tshwm sim yog tias cov txheej txheem xeem tau ua tiav.

CEEB TOOM THIAB KEV TIV THAIV

•Kev kuaj tus kheej hauv vitro diagnostic siv nkaus xwb.This tset cassette yog siv rau ib zaug thiab tsis tuaj yeem rov siv dua lossis siv los ntawm ntau tus neeg.

•Tsis txhob siv cov khoom no ua lub hauv paus rau kev kuaj mob lossis tshem tawm tus kab mob SARS-CoV-2 lossis qhia txog kev kis tus kabmob COVID-19.

• Thov nyeem tag nrho cov ntaub ntawv hauv daim ntawv no ua ntej ua qhov kev xeem.

•Tsis txhob siv cov khoom no tom qab hnub tas sij hawm.

•Cov ntawv xeem yuav tsum nyob twj ywm hauv lub hnab kaw kom txog thaum siv.

•Tag nrho cov qauv yuav tsum raug suav hais tias muaj peev xwm ua rau muaj kev phom sij thiab ua haujlwm tib yam li tus neeg kis tus kab mob.

• Kev sim rau cov menyuam yaus thiab cov hluas yuav tsum tau siv nrog tus neeg laus.

•Cov ntawv xeem siv yuav tsum muab pov tseg raws li tsoom fwv teb chaws, lub xeev thiab cov kev cai hauv zos.

• Tsis txhob siv qhov ntsuas no rau cov menyuam yaus hnub nyoog qis dua 2 xyoos.

• Cov me nyuam me yuav tsum tau swab nrog kev pab los ntawm ib tug neeg laus thib ob.

• Ntxuav tes kom huv si ua ntej thiab tom qab tuav.

TXOJ CAI

Cov ntaub ntawv muab

•Test Cassettes: txhua lub cassette nrog desiccant hauv ib lub hnab ntawv nyiaj

•Prepackaged Extraction Reagents:

•Sterilized Swabs: ib leeg siv sterile swab rau cov qauv sau

•Package Insert

Cov ntaub ntawv xav tau tab sis tsis muab

• Timer

NYIAJ THIAB STABILITY

• Khaws cia li ntim rau hauv lub hnab ntim ntawm qhov kub (4-30 ℃ lossis 40-86 ℉).Cov khoom siv ruaj khov nyob rau hauv hnub tas sij hawm luam tawm ntawm daim ntawv lo.

• Ib zaug qhib lub hnab, qhov kev sim yuav tsum siv li ntawm ib teev.Kev raug kub thiab ntub ib puag ncig ntev yuav ua rau cov khoom tsis zoo.

• Tsis txhob khov.

TSEEM CEEB

Cov qauv tau txais thaum ntxov thaum cov tsos mob pib yuav muaj cov kab mob siab tshaj plaws;Cov qauv uas tau txais tom qab tsib hnub ntawm cov tsos mob feem ntau yuav ua rau cov txiaj ntsig tsis zoo thaum piv rau RT-PCR kev soj ntsuam.Kev sau cov qauv tsis zoo, kev tuav cov qauv tsis raug thiab / lossis kev thauj mus los yuav ua rau cov txiaj ntsig tsis raug;Yog li ntawd, kev cob qhia hauv kev sau cov qauv yog pom zoo vim qhov tseem ceeb ntawm cov qauv zoo kom tau txais cov txiaj ntsig kev xeem raug.Kev lees txais cov qauv rau kev kuaj yog ib qho ncaj qha qhov ntswg swab specimen tau los ntawm dual nares sau txoj kev.Npaj lub raj rho tawm raws li Txoj Cai Kev Xeem thiab siv cov khoom tsis huv uas muaj nyob rau hauv cov khoom siv rau kev sau cov qauv.

Nasal Swab Specimen Collection

1. Tshem tawm lub swab ntawm lub pob.

2. Tilt tus neeg mob lub taub hau rov qab txog 70 °.

3.1-2Thaum maj mam tig lub swab, ntxig swab txog 2.5 cm (1 nti) rau hauv lub qhov ntswg kom txog rau thaum tsis muaj zog ntawm turbinates.

4.Tig lub swab ob peb zaug tiv thaiv phab ntsa ntawm qhov ntswg thiab rov ua dua hauv lwm lub qhov ntswg siv tib lub swab.

Kev thauj khoom thiab kev cia khoom

Tsis txhob xa rov qab lub swab mus rau qhov qub swab ntim.Cov khoom ntim tshiab tshiab yuav tsum tau ua tiav sai li sai tau, tab sis tsis pub dhau ib teev tom qab sau cov qauv.

KEV KAWM NTAWV

Nco tseg:Tso cai rau cov ntawv xeem, cov tshuaj reagents thiab cov qauv kom sib npaug rau hauv chav tsev kub (15-30 ℃ lossis 59-86 ℉) ua ntej kuaj.

1. Muab lub raj rho tawm hauv qhov chaw ua haujlwm.

2.Peel tawm aluminium foil foob los ntawm sab saum toj ntawm lub raj rho tawm uas muaj cov raj rho tawm uas muaj cov extraction tsis.

3.Sampling hais txog ntu 'Specimen Collection'.

4.Insert lub qhov ntswg qhov ntswg mus rau hauv lub raj extraction uas muaj extraction reagent.Yob lub swab tsawg kawg 5 zaug thaum nias lub taub hau tawm tsam hauv qab thiab sab ntawm lub raj rho tawm.Tso lub qhov ntswg qhov ntswg rau hauv lub raj rho tawm rau ib feeb.

5. Tshem tawm lub qhov ntswg qhov ntswg thaum tuav lub tog raj kom tshem tawm cov kua dej los ntawm cov swab.Cov tshuaj rho tawm yuav raug siv los ua cov qauv kuaj.6. Npog lub raj rho tawm nrog lub taub ntim kom nruj.

7. Tshem tawm cov ntawv xeem los ntawm lub hnab kaw.

8.Tom qab lub raj rho tawm, tuav lub raj kom ncaj, hloov 3 tee (kwv yees li 100 μL) maj mam mus rau qhov zoo (S) ntawm cov ntawv xeem, ces pib lub timer.

9. Tos kom cov kab xim tuaj yeem tshwm.Txhais cov txiaj ntsig kev xeem ntawm 15 feeb.Tsis txhob nyeem cov txiaj ntsig tom qab 20 feeb.

[Kev ua tau zoo yam ntxwv]

Clinical Performance

Txhawm rau kwv yees qhov kev kho mob ua ntej ntawm COVID-19 Antigen Rapid Test Cassette thiab PCR comparotor, 628 qhov ntswg qhov ntswg tau sau los ntawm cov neeg mob uas xav tias muaj tus kab mob COVID-19.Cov ntaub ntawv qhia txog COVID-19 Antigen Rapid Test Cassette (Nasal Swab) raws li hauv qab no .

COVID-19 antigen		RT-PCR		Tag nrho
COVID-19 antigen		Qhov zoo	Tsis zoo	Tag nrho
HEO ®	Qhov zoo	172	0	172
HEO ®	Tsis zoo	3	453 ib	456
Tag nrho		175	453 ib	628 ib

PPA = 98.28% (172/175), (95% CI: 95.08% ~ 99.64%) NPA = 100% (453/453), (95% CI: 99.34% ~ 100%)

PPA - Daim Ntawv Pom Zoo Tshaj Lij (Sensitivity) NPA - Daim Ntawv Pom Zoo Pom Zoo (Tshwj xeeb)

Limit of Detection (Analytical Sensitivity)

Txoj kev tshawb no siv kab mob SARS-CoV-2 kab mob (Isolate USA-WA1/2020 NR- 52287), uas yog cua sov inactivated thiab spiked rau hauv nasal swab specimen.Qhov txwv ntawm Kev Ntsuas (LoD) yog 1.0 × 10²TCID₅₀/ml.

Cross Reactivity (Kev tsom xam tshwj xeeb)

Hla reactivity tau soj ntsuam los ntawm kev sim 32 commensal thiab pathogenic microorganisms uas yuav muaj nyob rau hauv lub qhov ntswg kab noj hniav.

Tsis muaj kev sib cuam tshuam tau pom nrog recombinant MERS-CoV NP protein thaum kuaj ntawm qhov concentration ntawm 50 pg / mL.

Tsis muaj kev cuam tshuam cuam tshuam nrog cov kab mob hauv qab no thaum kuaj ntawm qhov concentration ntawm 1.0 × 106 PFU / mL: Influenza A (H1N1), Influenza A (H1N1pdm09), Influenza A (H3N2), Influenza B (Yamagata), Influenza B ( Victoria), Adenovirus (hom 1, 2, 3, 5, 7, 55), Human metapneumovirus,

Tus kab mob Parainfluenza (hom 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

Tsis muaj cov kab mob sib kis tau pom nrog cov kab mob hauv qab no thaum kuaj ntawm qhov ntsuas ntawm 1.0 × 107 CFU / mL: Mycoplasma pneumoniae, Chlamy-dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (pawg A), Streptocococcus pneumoniae, Staphylococcus aureus.

Kev cuam tshuam

Cov tshuaj muaj peev xwm cuam tshuam hauv qab no tau raug soj ntsuam nrog KEVID-19 Antigen Rapid Test Cassette (Nasal Swab) ntawm qhov ntau tau teev tseg hauv qab no thiab pom tias tsis muaj kev cuam tshuam rau kev xeem.

Tshuaj Concentration

Mucin 2%

Benzocaine 5 mg/mL Saline nasal tsuag 15%

Oxymetazoline 15%

Tobramycin 5 μg / mL Oseltamivir phosphate 10 mg / mL

Arbidol 5 mg / ml

Fluticasone propionate 5%

Triamcinolone 10 mg/ml

Cov ntshav tag nrho 4%

Menthol 10 mg/ml

Phenylephrine 15%

Mupirocin 10 mg/ml

Zanamivir 5 mg/ml

Ribavirin 5 mg / ml

Dexamethasone 5 mg/ml

Histamine 10 mg/mL dihydrochloride

High-dose Hook Effect

Tus Kab Mob Khaus Viv-19 Antigen Rapid Test Cassette (Colloidal Gold) tau sim txog 1.0 × 10⁵TCID50/mL ntawm inactivated SARS-CoV-2 thiab tsis pom muaj kev sib txuas siab.

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