Lag luam wholesale COVID-19 Antigen Rapid Test Cassette (Colloidal Kub) tuam ntxhab thiab cov muag khoom |HEO

COVID-19 Antigen Rapid Test Cassette (Colloidal Kub)

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Product Detail

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[Thov siv]
Tus Kab Mob Khaus Viv-19 Antigen Rapid Test Cassette (Saliva) yog ib qho lateral flow immunoassay npaj rau kev soj ntsuam zoo SARS-CoV-2 nucleocapsid antigens hauv qaub ncaug los ntawm cov tib neeg uas xav tias 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 cov qaub ncaug thaum lub sijhawm 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 los yog 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.
Tus Kab Mob Khaus Viv-19 Antigen Rapid Test Cassette (Saliva) yog npaj rau kev siv los ntawm cov kws kho mob lossis cov neeg ua haujlwm tau txais kev cob qhia uas muaj peev xwm ua tau zoo rau kev kuaj ntshav qab zib.Cov khoom yuav raug siv nyob rau hauv ib qho chaw kuaj thiab tsis-lab ib puag ncig uas ua tau raws li qhov yuav tsum tau teev tseg hauv Cov Lus Qhia rau Kev Siv thiab cov kev cai hauv zos.
[SUMMARY]
Novel coronaviruses (SARS-CoV-2) belongs to p 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.
[TSEEM CEEB]
Tus Kab Mob Khaus Viv-19 Antigen Rapid Test Cassette (Saliva) 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 conjugated nrog cov xim microparticles yog siv los ua tus ntes thiab tshuaj tsuag rau ntawm lub ncoo conjugation.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 nyuaj no tsiv mus nyob rau ntawm daim nyias nyias ntawm capillary kev txiav txim kom txog rau thaum txoj kab xeem, qhov uas nws yuav raug ntes los ntawm pre-coated 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.
[Kev ceeb toom thiab kev ceeb toom]
•Rau kev kuaj mob hauv vitro nkaus xwb.
•Rau cov kws kho mob thiab cov tib neeg uas tau kawm nyob rau hauv qhov chaw kho mob.
•Tsis txhob siv cov khoom no ua lub hauv paus rau kev kuaj mob lossis cais tawm
Tus kab mob SARS-CoV-2 los yog qhia txog kev kis tus kab mob COVID-19.
•Tsis txhob siv cov khoom no tom qab hnub tas sij hawm.
• Thov nyeem tag nrho cov ntaub ntawv hauv daim ntawv no ua ntej ua qhov kev xeem.
•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.
•Cov ntawv xeem siv yuav tsum muab pov tseg raws li tsoom fwv teb chaws, lub xeev thiab cov kev cai hauv zos.
[COMPOSITION]
Cov ntaub ntawv muab
•Test Cassettes: txhua lub cassette nrog desiccant hauv ib lub hnab ntawv nyiaj
•Extraction Reagents: ampoule muaj 0.3 mL ntawm extraction reagent
• Cov neeg sau qaub ncaug
• Cov raj ntim khoom
• Cov khoom poob
•Package Insert
Cov ntaub ntawv xav tau tab sis tsis muab
• Timer
[KHOV CHAW THIAB STABILITY]
• Khaws cia li ntim rau hauv lub hnab ntim ntawm qhov kub (4-30 ° C lossis 40-86T).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.
•LOT thiab hnub tas sij hawm tau luam tawm ntawm daim ntawv lo.
[SPEIMEN COLLECTION THIAB Kev Npaj]
Tsis txhob tso ib yam dab tsi hauv qhov ncauj nrog rau cov khoom noj, dej haus, cov pos hniav los yog cov khoom lag luam luam yeeb yam tsawg kawg 30 feeb ua ntej sau.
Siv lub raj xa dej thiab cov kua qaub sau cov qaub ncaug.Ntxig tus qaub ncaug sau rau hauv lub raj xa dej, tom qab ntawd muab cov khoom qaub ncaug ze rau ntawm daim di ncauj thiab cia cov qaub ncaug ntws mus rau hauv lub raj xa dej.Qhov ntim ntawm qaub ncaug yuav tsum nyob ntawm qhov ntsuas ntsuas (kwv yees li 300 | jL).Yog hais tias qhov ntim ntawm cov qaub ncaug ntau dhau, siv lub dropper kom tshem tawm cov qaub ncaug ntau dhau mus txog thaum kawg ntawm cov kua nplaum ntawm qhov ntsuas (kwv yees li 300pL).[Thov siv]
Tus Kab Mob Khaus Viv-19 Antigen Rapid Test Cassette (Saliva) yog ib qho lateral flow immunoassay npaj rau kev soj ntsuam zoo SARS-CoV-2 nucleocapsid antigens hauv qaub ncaug los ntawm cov tib neeg uas xav tias 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 cov qaub ncaug thaum lub sijhawm 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 los yog 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.
Tus Kab Mob Khaus Viv-19 Antigen Rapid Test Cassette (Saliva) yog npaj rau kev siv los ntawm cov kws kho mob lossis cov neeg ua haujlwm tau txais kev cob qhia uas muaj peev xwm ua tau zoo rau kev kuaj ntshav qab zib.Cov khoom yuav raug siv nyob rau hauv ib qho chaw kuaj thiab tsis-lab ib puag ncig uas ua tau raws li qhov yuav tsum tau teev tseg hauv Cov Lus Qhia rau Kev Siv thiab cov kev cai hauv zos.
[SUMMARY]
Novel coronaviruses (SARS-CoV-2) belongs to p 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.
[TSEEM CEEB]
Tus Kab Mob Khaus Viv-19 Antigen Rapid Test Cassette (Saliva) 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 conjugated nrog cov xim microparticles yog siv los ua tus ntes thiab tshuaj tsuag rau ntawm lub ncoo conjugation.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 nyuaj no tsiv mus nyob rau ntawm daim nyias nyias ntawm capillary kev txiav txim kom txog rau thaum txoj kab xeem, qhov uas nws yuav raug ntes los ntawm pre-coated 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.
[Kev ceeb toom thiab kev ceeb toom]
•Rau kev kuaj mob hauv vitro nkaus xwb.
•Rau cov kws kho mob thiab cov tib neeg uas tau kawm nyob rau hauv qhov chaw kho mob.
•Tsis txhob siv cov khoom no ua lub hauv paus rau kev kuaj mob lossis cais tawm
Tus kab mob SARS-CoV-2 los yog qhia txog kev kis tus kab mob COVID-19.
•Tsis txhob siv cov khoom no tom qab hnub tas sij hawm.
• Thov nyeem tag nrho cov ntaub ntawv hauv daim ntawv no ua ntej ua qhov kev xeem.
•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.
•Cov ntawv xeem siv yuav tsum muab pov tseg raws li tsoom fwv teb chaws, lub xeev thiab cov kev cai hauv zos.
[COMPOSITION]
Cov ntaub ntawv muab
•Test Cassettes: txhua lub cassette nrog desiccant hauv ib lub hnab ntawv nyiaj
•Extraction Reagents: ampoule muaj 0.3 mL ntawm extraction reagent
• Cov neeg sau qaub ncaug
• Cov raj ntim khoom
• Cov khoom poob
•Package Insert
Cov ntaub ntawv xav tau tab sis tsis muab
• Timer
[KHOV CHAW THIAB STABILITY]
• Khaws cia li ntim rau hauv lub hnab ntim ntawm qhov kub (4-30 ° C lossis 40-86T).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.
•LOT thiab hnub tas sij hawm tau luam tawm ntawm daim ntawv lo.
[SPEIMEN COLLECTION THIAB Kev Npaj]
Tsis txhob tso ib yam dab tsi hauv qhov ncauj nrog rau cov khoom noj, dej haus, cov pos hniav los yog cov khoom lag luam luam yeeb yam tsawg kawg 30 feeb ua ntej sau.
Siv lub raj xa dej thiab cov kua qaub sau cov qaub ncaug.Ntxig tus qaub ncaug sau rau hauv lub raj xa dej, tom qab ntawd muab cov khoom qaub ncaug ze rau ntawm daim di ncauj thiab cia cov qaub ncaug ntws mus rau hauv lub raj xa dej.Qhov ntim ntawm qaub ncaug yuav tsum nyob ntawm qhov ntsuas ntsuas (kwv yees li 300 | jL).Yog hais tias qhov ntim ntawm cov qaub ncaug ntau dhau, siv lub dropper kom tshem tawm cov qaub ncaug ntau dhau mus txog thaum kawg ntawm cov kua nplaum ntawm qhov ntsuas (kwv yees li 300pL).

Kev thauj khoom thiab kev cia khoom

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.

[TEST PROCEDURE]

Lus Cim: Tso cai rau cov ntawv xeem, cov tshuaj reagents thiab cov qauv kom sib npaug rau chav tsev kub (15-30 ° C lossis 59-86T) ua ntej kuaj.

Muab lub raj ntim nrog cov qaub ncaug uas muaj qaub ncaug rau hauv qhov chaw ua haujlwm.Unscrew lub hau ntawm ib tug extraction reagent.Ntxiv tag nrho cov extraction reagents rau hauv lub raj sau.

Muab pov tseg cov khoom qaub ncaug;Npog lub raj xa khoom nrog lub taub ntim rau ntawm lub raj ntim khoom.Co lub raj xa dej ntau tshaj peb zaug kom sib tov cov qaub ncaug thiab cov tshuaj rho tawm, tom qab ntawd nyem cov tshuaj sib tov kaum zaug kom cov qaub ncaug sib xyaw kom huv si.

Tshem tawm cov ntawv xeem los ntawm lub hnab kaw.

Rov qab lub raj sau, tuav lub raj kom ncaj, hloov 3 tee (kwv yees li 100pL) maj mam mus rau qhov zoo (S) ntawm cov ntawv xeem, ces pib lub timer.

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

[Kev txhais lus ntawm cov txiaj ntsig]
Zoo \|	§	Ob kab tshwm.Ib kab xim zoo li H c ntawm cheeb tsam tswj (C), thiab lwm xim Jt\|jne tshwm sim ntawm cheeb tsam xeem (T), tsis hais- tsawg ntawm qhov kev siv ntawm kab xeem.
Tsis zoo		Ib kab xim tshwm nyob rau hauv cheeb tsam tswj (C), thiab tsis muaj kab tshwm nyob rau hauv cheeb tsam xeem (T).
Tsis raug		Tswj kab tsis tshwm sim.Tsis txaus,Cov qauv ntim lossis cov txheej txheem tsis raug 5 cov txheej txheem yog feem ntau yog vim li cas rau c tswj kab tsis ua haujlwm.Txheeb xyuas cov txheej txheem thiab Jtrov ua dua qhov kev xeem uas siv cov ntawv xeem tshiab.YogJ)Qhov teeb meem tshwm sim, tsis txhob siv ntau tam sim ntawd thiab tiv tauj koj tus neeg muag khoom hauv zos.

[QHOV TSEEM CEEB]

Cov txheej txheem tswj tau suav nrog hauv qhov kev xeem.Ib kab xim uas tshwm nyob rau hauv cheeb tsam tswj (C) yog suav tias yog kev tswj hwm txheej txheem sab hauv.Nws lees paub qhov ntim cov qauv txaus, tsim nyog daim nyias nyias wicking thiab raug txheej txheem txheej txheem.

Cov qauv tswj tsis tau muab nrog cov khoom siv no.Txawm li cas los xij, nws raug pom zoo tias cov kev tswj xyuas qhov zoo thiab qhov tsis zoo yuav raug kuaj raws li kev sim ua haujlwm zoo kom paub meej tias cov txheej txheem kev xeem thiab kom ua tau raws li qhov ua tau zoo.

[LIMITATIONS]

Cov khoom raug txwv los muab kev kuaj pom zoo.Qhov kev siv ntawm cov kab xeem tsis tas yuav cuam tshuam rau qhov concentration ntawm antigen ntawm cov qauv.
Cov txiaj ntsig tsis zoo tsis txwv kev kis tus kab mob SARS-CoV-2 thiab yuav tsum tsis txhob siv los ua lub hauv paus rau kev txiav txim siab tswj tus neeg mob.
Tus kws kho mob yuav tsum txhais cov txiaj ntsig nrog rau tus neeg mob keeb kwm, kev tshawb pom lub cev, thiab lwm yam kev kuaj mob.
Qhov tshwm sim tsis zoo tuaj yeem tshwm sim yog tias qhov ntau ntawm SARS-CoV-2 antigens tam sim no nyob rau hauv cov qauv qis dua qhov kev kuaj pom ntawm qhov kev ntsuam xyuas, lossis tus kab mob no tau dhau los ntawm kev hloov pauv ntawm cov amino acid me me hauv thaj tsam thaj tsam epitope lees paub los ntawm monoclonal antibodies. siv nyob rau hauv qhov kev xeem.

[Kev ua tau zoo yam ntxwv]

Clinical Performance

Kev kho mob ntawm COVID-19 Antigen Rapid Test Cassette (Saliva) tau tsim nyob rau hauv cov kev tshawb fawb yav tom ntej nrog cov qauv sau los ntawm 628 tus neeg mob cov tsos mob (hauv 7 hnub ntawm qhov pib) thiab cov neeg mob asymptomatic uas xav tias yog COVID-19.

Cov ntaub ntawv Summary ntawm COVID-19 Antigen Rapid Test raws li hauv qab no:

RT-PCR lub voj voog pib (Ct) yog tus nqi teeb liab cuam tshuam.Tus nqi qis Ct qhia tias muaj kab mob ntau dua.Qhov rhiab heev raug xam rau qhov sib txawv Ct tus nqi ntau (Ct tus nqiW37)

Antfgeno COVID-19		RT-PCR		Tag nrho
Antfgeno COVID-19		Positivo	Negativo	Tag nrho
HEO ®	Positivo	172	0	172
HEO ®	Negativo	3	453 ib	456
Tag nrho		175	453 ib	628 ib

Daim Ntawv Pom Zoo Pom Zoo (PPA) = 98.28% (172/175), (95% CI: 95.08% ~ 99.41%)

Daim ntawv cog lus tsis zoo (NPA) = 100% (453/453), (95% CI: 99.15% ~ 100%)

PPA - Daim Ntawv Pom Zoo Feem Xyuam (Sensitivity)

NPA - Daim Ntawv Pom Zoo Tsis Pom Zoo (Specificity)

Limit of Detection (Analytical Sensitivity)

Txoj kev tshawb no siv kab lis kev cai kab mob SARS-CoV-2 (Isolate Hong Kong/ VM20001061/2020, NR-52282), uas yog cua sov inactivated thiab spiked rau hauv qaub ncaug.Qhov Limit of Detection (LoD) yog 8.6 X 10²TCIDso/ml.

Cross Reactivity (Kev tsom xam tshwj xeeb)

Hla reactivity raug soj ntsuam los ntawm kev ntsuam xyuas 32 commensal thiab pathogenic microorganisms uas yuav muaj nyob rau hauv lub qhov ncauj.

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 1.0x10⁶PFU/mL: Influenza A (H1N1), Influenza A

(H1N1 pdm09), Influenza A(H3N2), Influenza B(Yamagata), Influenza B(Victoria), Adenovirus (hom 1, 2, 3, 5, 7, 55), Human metapneumovirus, Parainfluenza virus (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 concentration ntawm 1.0x10' CFU/mL: Mycoplasma pneumoniae, Chlamy dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (pawg A), Streptocococcus pneumoniae. aureus.

Kev cuam tshuam

Cov tshuaj muaj peev xwm cuam tshuam hauv qab no tau raug soj ntsuam nrog COVID-19 Antigen Rapid Test Cassette (Saliva) ntawm cov ntsiab lus hauv qab no thiab pom tias tsis cuam tshuam rau kev ua haujlwm ntawm tes.

Tshuaj	Nco ntsoov	Tshuaj	Nco ntsoov
Mucin	2%	Cov ntshav tag nrho	4%
Benzocaine	5 mg/ml	Menthol	10 mg/ml
Saline qhov ntswg	15%	Phenylephrine	15%
Oxymetazoline	15%	Histamine dihydrochloride	10 mg/ml
Tobramycin	5 pg/ml	Mupirocin	10 mg/ml
Oseltamivir phosphate	10 mg/ml	Zanamivir	5 mg/ml
Arbidol	5 mg/ml	Ribavirin	5 mg/ml
Fluticasone propionate hmoov	5%	Dexamethasone	5 mg/ml
Triamcinolone	10 mg/ml

High-dose Hook Effect

Tus kab mob COVID-19 Antigen Rapid Test Cassette (Saliva) tau kuaj txog li 1.15x1 o' TCIDso/mL ntawm inactivated SARS-CoV-2 thiab tsis pom muaj kev sib txuas siab.

Hangzhou Heo Technology Co., Ltd.

Chaw nyob: Room201, Building3, No.2073 Jinchang Road,

Liangzhu Street, Yuhang District, Hangzhou, Tuam Tshoj Postcode: 311113

Tel: 0086-571-87352763 E-mail:52558565@qq.com

Lotus NL BV Chaw Nyob: Koningin Julianaplein 10, le Verd,

2595AA, Lub Hague, Netherlands.E-mail:Peter@lotusnl.com

Tel: +31644168999

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 txhais cov ntsiab lus

Qhov zoo

C T

Ob kab tshwm.Ib txoj kab uas muaj xim zoo nkauj tshwm ntawm qhov kev siv ntawm cov kab xeem.

Tsis zoo

Ib kab xim tshwm nyob rau hauv cheeb tsam tswj (C), thiab tsis muaj kab tshwm nyob rau hauv cheeb tsam xeem (T).

Tsis raug

C T

Tswj kab ua tsis tiav to tshwm. Cov khoom ntim tsis txaus lossis cov txheej txheem tsis raug yog cov laj thawj feem ntau rau kev tswj kab tsis ua haujlwm.Tshawb xyuas cov txheej txheem thiab rov ua qhov kev xeem uas siv lub tshuab ntsuas tshiab.Yog tias muaj teeb meem tshwm sim, txiav tsis siv ntau tam sim ntawd thiab tiv tauj koj tus neeg muag khoom hauv zos.

QUALITY CONTROL

TXOJ CAI

• Cov khoom siv yog txwv los muab kev kuaj pom zoo.Qhov kev siv ntawm cov kab xeem tsis tas yuav cuam tshuam rau qhov concentration ntawm antigen ntawm cov qauv.

• Cov txiaj ntsig tsis zoo tsis txwv tus kab mob SARS-CoV-2 thiab yog tias muaj cov tsos mob tshwm sim koj yuav tsum nrhiav kev sim ntxiv tam sim ntawm Txoj Kev PCR.

• Tus kws kho mob yuav tsum txhais cov txiaj ntsig nrog rau tus neeg mob keeb kwm, kev tshawb pom lub cev, thiab lwm yam kev kuaj mob.

• Cov txiaj ntsig tsis zoo uas tau los ntawm Cov Khoom Siv no yuav tsum tau lees paub los ntawm PCR.Qhov tshwm sim tsis zoo tuaj yeem tshwm sim yog tias qhov ntau ntawm SARS-CoV-2 antigens tam sim no nyob rau hauv cov qauv qis dua qhov kev kuaj pom ntawm qhov kev ntsuam xyuas, lossis tus kab mob no tau dhau los ntawm kev hloov pauv ntawm cov amino acid me me hauv thaj tsam thaj tsam epitope lees paub los ntawm monoclonal antibodies. siv nyob rau hauv qhov kev xeem.

• Cov ntshav ntau dhau ntawm cov hnoos qeev tuaj yeem cuam tshuam rau kev ua haujlwm thiab yuav ua rau cov txiaj ntsig tsis zoo.

TXOJ CAI TSHIAB

Clinical Performance

COVID-19 antigen		RT-PCR		Totale
COVID-19 antigen		Qhov zoo	Tsis zoo	Totale
HEO ®	Qhov zoo	212	0	212
HEO ®	Tsis zoo	3	569 ib	572 ib
Tag nrho		215	569 ib	784 ib

PPA = 98.60% (212/215), (95% CI: 95.68% ~ 99.71%) NPA = 100% (569/569), (95% CI: 99.47% ~ 100%)

PPA - Daim Ntawv Pom Zoo Feem Xyuam (Sensitivity) NPA - Daim Ntawv Pom Zoo Pom Zoo (Specificity) 95% * Kev ntseeg siab

Hnub txij li cov tsos mob	RT-PCR	HEO TECHNOLOGY	Daim ntawv cog lus (%)
0-3	95	92	96.84%
4-7	120	120	100%

CT Tus nqi	RT-PCR	HEO TECHNOLOGY	Daim ntawv cog lus (%)
Ct≤30	42	42	100%
Ct≤32	78	78	100%
Ct≤35	86	85	98.84%
37	9	7	77.78%

Limit of Detection (Analytical Sensitivity)

Txoj kev tshawb no siv kab lis kev cai kab mob SARS-CoV-2, uas yog cua sov inactivated thiab spiked rau hauv qhov ntswg swab specimen.Qhov txwv ntawm Kev Ntsuas (LoD) yog 1.0 × 102 TCID50 / 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 (H7N9), 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 concentration ntawm 1.0 × 107 CFU / mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococ- cus pyogenes (pawg A), Streptocococcus. Albicans 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	Nco ntsoov	Tshuaj	Nco ntsoov
Mucin	2%	Cov ntshav tag nrho	4%
Benzocaine	5 mg/ml	Menthol	10 mg/ml
Saline qhov ntswg	15%	Phenylephrine	15%
Oxymetazoline	15%	Mupirocin	10 mg/ml
Tobramycin	5 μg / ml	Zanamivir	5 mg/ml
Oseltamivir phosphate	10 mg/ml	Ribavirin	5 mg/ml
Arbidol	5 mg/ml	Dexamethasone	5 mg/ml
Fluticasone propionate hmoov	5%	Histamine dihydrochloride	10 mg/ml
Triamcinolone	10 mg/ml	Histamine dihydrochloride	10 mg/ml

High-dose Hook Effect

Qhov COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) tau sim txog 1.0 × 10 5 TCID50 / mL ntawm inactivated SARS-CoV-2 thiab tsis pom muaj kev sib tw siab.

Cov lus nug nquag

1.How SARS-CoV-2 Antigen Rapid Test ua haujlwm li cas?Qhov kev sim no yog rau kev kuaj pom zoo ntawm SARS-CoV-2 antigens nyob rau hauv tus kheej-collected swab specimens.Cov txiaj ntsig zoo qhia tias SARS-CoV-2 antigens muaj nyob hauv cov qauv.

Thaum twg yuav tsum tau siv qhov kev xeem?

SARS-CoV-2 antigen tuaj yeem kuaj pom hauv cov kab mob ua pa nyuaj, nws raug nquahu kom khiav qhov kev sim thaum cov tsos mob suav nrog qhov tshwm sim sai sai ntawm yam tsawg kawg ib yam hauv qab no: hnoos, ua npaws, ua tsis taus pa, qaug zog, tsis qab los noj mov, myalgia.

Cov txiaj ntsig puas tuaj yeem raug?

Cov txiaj ntsig yog qhov tseeb raws li cov lus qhia tau ua tib zoo saib xyuas.Txawm li cas los xij, qhov tshwm sim tuaj yeem ua tsis raug yog tias qhov ntim tsis txaus lossis SARS-CoV-2 Antigen Rapid Test tau ntub dej ua ntej kev sim ua, lossis yog tias tus naj npawb ntawm cov extraction buffer drops tsawg dua 3 lossis ntau dua 4. Tsis tas li ntawd, vim yog cov qauv kev tiv thaiv kab mob. koom nrog, muaj qhov muaj feem ntawm cov txiaj ntsig tsis tseeb hauv qhov tsis tshua muaj.Kev sab laj nrog tus kws kho mob yeej ib txwm pom zoo rau cov kev sim no raws li cov hauv paus ntsiab lus ntawm kev tiv thaiv kab mob.

Yuav txhais li cas qhov kev ntsuam xyuas yog tias cov xim thiab qhov siv ntawm cov kab sib txawv?Cov xim thiab kev siv ntawm cov kab tsis muaj qhov tseem ceeb rau kev txhais lus.Cov kab yuav tsum tsuas yog homogeneous thiab pom meej.Qhov kev ntsuam xyuas yuav tsum raug suav hais tias yog qhov zoo txawm tias qhov kev siv xim ntawm cov kab xeem yog dab tsi.5.Kuv yuav tsum ua li cas yog tias qhov tshwm sim tsis zoo?

Qhov tshwm sim tsis zoo txhais tau hais tias koj tsis zoo lossis tias cov kab mob kis tsawg dhau

kom berecognized los ntawm kev xeem.Txawm li cas los xij, nws muaj peev xwm rau qhov kev sim no kom muab qhov txiaj ntsig tsis zoo uas tsis raug (qhov tsis zoo tsis zoo) hauv qee tus neeg uas muaj COVID-19.Qhov no txhais tau tias koj tuaj yeem tseem muaj COVID-19 txawm tias qhov kev sim tsis zoo.

Yog tias koj muaj cov tsos mob xws li mob taub hau, migraines, ua npaws, tsis hnov tsw thiab saj, hu rau lub chaw kho mob ze tshaj plaws uas siv cov cai ntawm koj lub zos.Tsis tas li ntawd, koj tuaj yeem rov sim dua nrog cov khoom siv kuaj tshiab.Nyob rau hauv cov ntaub ntawv ntawm kev ua xyem xyav, rov kuaj dua tom qab 1-2 hnub, vim tus mob coronavirus tsis tuaj yeem kuaj pom tseeb hauv txhua theem ntawm tus kab mob.Txoj cai nyob deb thiab kev nyiam huv yuav tsum tau ua.Txawm tias muaj cov txiaj ntsig tsis zoo, yuav tsum tau ua raws li txoj cai nyob deb thiab kev nyiam huv, kev tsiv teb tsaws chaw / kev mus ncig, mus koom cov xwm txheej thiab lwm yam yuav tsum ua raws li koj cov lus qhia / cov cai hauv zos.6.Kuv yuav tsum ua li cas yog tias qhov tshwm sim zoo?

Qhov txiaj ntsig zoo txhais tau tias muaj SARS-CoV-2 antigens.Cov txiaj ntsig zoo txhais tau tias nws muaj feem ntau koj muaj COVID-19.Tam sim ntawd mus rau hauv kev cais tus kheej raws li cov lus qhia hauv zos thiab tam sim ntawd hu rau koj tus kws kho mob / kws kho mob lossis chaw saib xyuas kev noj qab haus huv hauv zos raws li cov lus qhia ntawm koj cov cai hauv zos.Koj qhov kev xeem yuav raug kuaj los ntawm PCR kev kuaj pom tseeb thiab koj yuav raug piav qhia cov kauj ruam tom ntej.