SARS-CoV-2 Antigen Assay Kit

SARS-CoV-2 Antigen Assay Kit

(Immunochromatography Method) Product Manual

【PZotsatira RODUCT NAME】SARS-CoV-2 Antigen Assay Kit(Njira ya Immunochromatography)

【PACKAGING SPECIFICATIONS】1 Mayeso / Kit , 25Mayeso / Kit, 100Mayeso / Kit

【ABSTRACT】

Ma coronaviruses atsopano ndi amtundu wa β. COVID-19 ndi matenda opatsirana pachimake. Nthawi zambiri anthu amavutika. Pakadali pano, odwala omwe ali ndi kachilombo ka coronavirus ndiye gwero lalikulu la matenda; anthu omwe ali ndi matenda asymptomatic amathanso kukhala gwero lopatsirana. Malingana ndi kafukufuku wamakono wa epidemiological, nthawi yobereketsa ndi masiku 1 mpaka 14, makamaka masiku 3 mpaka 7. The mawonetseredwe aakulu monga malungo, kutopa ndi youma chifuwa. Kutsekeka kwa mphuno, mphuno, zilonda zapakhosi, myalgia ndi kutsekula m'mimba zimapezeka nthawi zingapo.

【EXPECTED USAGE】

Chidachi chimagwiritsidwa ntchito pozindikira bwino za ma antigen a coronaviruses (SARS-CoV-2) m'mphuno zapakhosi zamunthu, swabs zapakhosi, malovu akumbuyo a oropharyngeal, sputum ndi ndowe.

Ndiwoyenera kuzindikiridwa ndi akatswiri mu vitro, osati kugwiritsa ntchito nokha.

Izi zimangogwiritsidwa ntchito m'ma laboratories azachipatala kapena kuyezetsa mwachangu ndi ogwira ntchito zachipatala. Sichingagwiritsidwe ntchito poyesa kunyumba.

Sichingagwiritsidwe ntchito ngati maziko ozindikiritsa ndikupatula chibayo choyambitsidwa ndi matenda a coronaviruses (SARS-CoV-2). Sikoyenera kuwunika ndi anthu wamba.

Zotsatira zoyezetsa zimafuna kutsimikiziridwa kwina, ndipo zotsatira zoyezetsa sizingalepheretse kuthekera kwa matenda.

Zida ndi zotsatira zoyezetsa ndizongowona zachipatala. Ndikofunikira kuti mawonetseredwe azachipatala a wodwala komanso mayeso ena a labotale aphatikizidwe kuti awunike mozama momwe alili.Zidazi sizingathe kusiyanitsa pakati pa SARS-CoV ndi SARS-CoV-2.

【PRINCIPLES OF THE PMtengo ROCEDURE】

Izi zimagwiritsa ntchito ukadaulo wa colloidal gold immunochromatography, kupopera golide wa colloidal wolembedwa SARS-CoV-2 mono-clonal antibody 1 pa golide pad The SARS-CoV-2 monoclonal antibody 2 imakutidwa pa nembanemba ya nitrocellulose ngati mzere woyeserera (T mzere) ndi mbuzi. Anti-mbewa IgG antibody imakutidwa ngati mzere wowongolera (C mzere). Pamene chiwerengero choyenera cha chitsanzo kuti chiyesedwe chikuwonjezedwa ku dzenje lachitsanzo la khadi loyesa, chitsanzocho chidzapita patsogolo pa khadi loyesa pansi pa capillary action. Ngati chitsanzocho chili ndi antigen ya SARS-CoV-2, antigen imamanga ndi golide wa colloidal wotchedwa SARS-CoV-2 monoclonal antibody 1, ndipo chitetezo chamthupi chimapanga chovuta chokhala ndi SARS-CoV-2 monoclonal antibody 2 Mzere wa T, wosonyeza mzere wa T wofiirira, kusonyeza kuti antigen ya SARS-CoV-2 ndi yabwino. Ngati mzere woyesera T sukuwonetsa mtundu ndikuwonetsa zotsatira zoyipa, zikutanthauza kuti chitsanzocho chilibe antigen ya SARS-CoV-2. Khadi loyesera limakhalanso ndi mzere wowongolera khalidwe C, mosasamala kanthu kuti pali mzere woyesera, mzere wamtundu wofiirira-wofiira C uyenera kuonekera. Ngati mzere wowongolera khalidwe C sukuwonekera, zimasonyeza kuti zotsatira zake ndizosavomerezeka, ndipo chitsanzochi chiyenera kuyesedwa kachiwiri.

【MAIN COMPONENTS】

1.Test khadi : Khadi loyesa lili ndi khadi la pulasitiki ndi mzere woyesera. Mzere woyeserera umapangidwa ndi nembanemba ya nitrocellulose (malo ozindikirirawo adakutidwa ndi SARS-CoV-2 monoclonal antibody 2, malo owongolera bwino amakutidwa ndi antimouse IgG antibody), ndi pad golide (yopaka golide wa colloidal wolembedwa SARS-CoV- 2 monoclonal antibody 1), pepala lachitsanzo, pepala loyamwa, ndi bolodi la PVC.

2. Yankho lachitsanzo la m'zigawo: Yankho la bafa lomwe lili ndi phosphate yogwirizana ndi zomwe zidali (pH6.5-8.0).

3. Chitsanzo m'zigawo chubu.

4. Wosabala swab, pakani, chotengera.

5. Buku.

Zindikirani: Zomwe zili m'magulu osiyanasiyana a zida sizingagwiritsidwe ntchito mosiyana.

【STORAGE NDI EXPIRATIION】

Nthawi yovomerezeka ndi miyezi 18 ngati mankhwalawa asungidwa m'malo a 2 ℃-30 ℃.

Mankhwalawa ayenera kugwiritsidwa ntchito mkati mwa mphindi 15 kamodzi thumba la zojambulazo litatsegulidwa. Phimbani chivindikirocho mwamsanga mutatulutsa njira yothetsera chitsanzo. Tsiku lotulutsa ndi tsiku lotha ntchito zalembedwa pa lebulo.

【SAMPLE REQUIREMENTS】

1. Zogwiritsidwa ntchito paziphuphu zapakhosi za munthu, zotsekemera zapakhosi, malovu akumbuyo a oropharyngeal, sputum ndi ndowe.

2. Zosonkhanitsira zitsanzo:

( 1)Kutolera katulutsidwe ka mphuno: Potolera zotuluka m’mphuno, ikani kansalu kosabala m’malo amene madzi atuluka kwambiri m’mphuno, tembenuzani pang’onopang’ono ndikukankhira mphuno mpaka mphunoyo itatsekeka, ndi kuzungulira katatu. nthawi zotsutsana ndi khoma la m'mphuno

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ndi kuchotsa swab.

(2)Kutulutsa kwapakhosi: Lowetsani nthiti pakhosi kotheratu kuchokera mkamwa, kukhazikika pakhoma la mmero ndi malo ofiira a m'kamwa, pukutani matani a pharyngeal ndi khoma lakumbuyo la pharyngeal mwamphamvu, pewani kukhudza lilime. ndi kuchotsa swab.

(3) Malovu akumbuyo oropharyngeal: Chitani ukhondo m'manja ndi sopo ndi madzi/zopakana ndi mowa. Tsegulani chidebecho. Pangani phokoso la Kruuua kuchokera pakhosi kuti muchotse malovu akukhosi, kenako kulavulira malovu (pafupifupi 2 ml) mumtsuko. Pewani kuipitsidwa ndi malovu akunja kwa chidebecho. Nthawi yoyenera yosonkhanitsa zitsanzo: Mukadzuka ndisanatsuka mano, kudya kapena kumwa.

3. Pangani chitsanzocho nthawi yomweyo ndi njira yothetsera chitsanzo yomwe imaperekedwa muzitsulo pambuyo pa kusonkhanitsa. Ngati sichingasinthidwe nthawi yomweyo, chitsanzocho chiyenera kusungidwa mu chubu chapulasitiki chouma, chosawilitsidwa komanso chosindikizidwa kwambiri. Zitha kusungidwa pa 2 ℃ -8 ℃ kwa maola 8, ndipo zitha kusungidwa kwa nthawi yayitali pa -70 ℃.

4. Zitsanzo zomwe zaipitsidwa kwambiri ndi zotsalira zapakamwa sizingagwiritsidwe ntchito poyesa mankhwalawa. Zitsanzo zomwe zasonkhanitsidwa kuchokera ku swabs zomwe zili zowoneka bwino kwambiri kapena zophatikizika sizovomerezeka kuyesa mankhwalawa. Ngati ma swabs ali oipitsidwa ndi magazi ambiri, savomerezedwa kuti ayesedwe. Sitikulimbikitsidwa kugwiritsa ntchito zitsanzo zomwe zimakonzedwa ndi njira yotulutsira zitsanzo zomwe sizinaperekedwe mu chida ichi poyesa mankhwalawa.

【TESTING METHOD】

Chonde werengani buku la malangizo mosamala musanayese. Chonde bweretsani ma reagents onse kutentha kwachipinda musanayese. Mayeso ayenera kuchitidwa kutentha.

Njira Zoyesera:

1. Kuchotsa Zitsanzo:

( 1)Malovu akumbuyo a oropharyngeal, sputum sample: Onjezani mopondapo 200ul zotulutsa madzi (pafupifupi madontho 6) mu chubu chochotsamo zitsanzo ndikusamutsa pafupifupi 200μL ya malovu atsopano kapena sputum kuchokera mchidebe kupita mu Chitsanzo cha chubu ndikugwedezani ndikusakaniza zonse.

(2) Zitsanzo za Chopondapo: Onjezani molunjika 200ul chitsanzo m'zigawo njira (pafupifupi 6 madontho) mu chitsanzo chubu m'zigawo, ntchito sampuli ndodo kunyamula pafupifupi 30mg zitsanzo zatsopano chimbudzi (Zofanana ndi kukula kwa machesi mutu). Ikani ndodo ya sampuli mu Chubu Chotsitsa Zitsanzo ndikugwedezani ndikusakaniza kwathunthu mpaka chopondapo chonse chitasungunuka.

(3) Swabs zitsanzo: Vertically kuwonjezera 500ul chitsanzo m'zigawo njira (pafupifupi 15 madontho) mu chubu chitsanzo m'zigawo. Ikani swab yosonkhanitsidwa mu yankho mu chubu chochotsera chitsanzo, ndikuzungulira pafupi ndi khoma lamkati la chubu choyesera pafupifupi nthawi 10 kuti chitsanzocho chisungunuke mu yankho momwe mungathere. Finyani mutu wa swab wa swab m'mphepete mwa khoma lamkati la chubu kuti madzi azikhala mu chubu momwe mungathere, chotsani ndikutaya. Phimbani chivindikiro.

2. Njira zozindikirira:

( 1) Khadi loyesa litabwerera ku kutentha kwa chipinda, tsegulani chikwama cha aluminiyamu chojambulapo ndikutulutsa khadi yoyesera ndikuyiyika mopingasa pa kompyuta.

(2) Onjezani 65ul (pafupifupi madontho a 2) a chitsanzo chosinthidwa kapena onjezani mwachindunji 65ul (pafupifupi madontho awiri) a njira yothetsera kachilombo ka HIV pa dzenje lachiyeso la khadi loyesa.

(3) Werengani zotsatira zomwe zawonetsedwa mkati mwa mphindi 15-30, ndipo zotsatira zomwe zawerengedwa pakatha mphindi 30 ndizosavomerezeka.

【INTERPRETATION OF TEST RESULTS】

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【LIMITATION OF DZIWANIION METHOD】

1. Kutsimikizira kwachipatala

Pofuna kuwunika momwe matenda akuyendera, kafukufukuyu adagwiritsa ntchito zitsanzo za COVID-19 kuchokera kwa anthu 252 komanso zitsanzo za COVID-19 kuchokera kwa anthu 686. Zitsanzozi zinayesedwa ndikutsimikiziridwa ndi njira ya RT-PCR. Zotsatira zake ndi izi:

a) Kukhudzidwa: 95.24% (240/252), 95%CI (91.83%, 97.52%)

b) Zodziwika: 99. 13% (680/686), 95%CI (98. 11%, 99.68%)

2. Malire ochepera ozindikira:

Pamene kachilombo kameneka kakuposa 400TCID50/ml, chiwerengero chodziwika bwino chimakhala chachikulu kuposa 95%. Pamene kachilombo kameneka kakucheperachepera 200TCID50/ml, chiwerengero chodziwika bwino chimakhala chocheperapo 95%, kotero kuti malire odziwika a mankhwalawa ndi 400TCID50/ml.

3. Kulondola:

Magulu atatu otsatizana a reagents adayesedwa molondola. Magulu osiyanasiyana a reagents adagwiritsidwa ntchito kuyesa zitsanzo zoyipa zomwezo nthawi 10 motsatizana, ndipo zotsatira zake zonse zinali zoipa. Magulu osiyanasiyana a reagents adagwiritsidwa ntchito kuyesa zitsanzo zabwino zomwezo ka 10 motsatizana, ndipo zotsatira zake zonse zinali zabwino.

4. HOOK zotsatira:

Pamene kachilombo ka HIV kamene kayezedwe kakafika pa 4.0 * 105TCID50/ml, zotsatira zake siziwonetsabe zotsatira za HOOK.

5. Cross-reactivity

Cross-reactivity of the Kit idawunikidwa. Zotsatira zake sizinawonetse kuyanjananso ndi chitsanzo chotsatirachi.

6. Zinthu Zosokoneza

Zotsatira zoyezetsa sizisokonezedwa ndi zinthu zomwe zili m'magulu otsatirawa:

【LIMITATION OF DZIWANIION METHOD】

1. Izi zimangoperekedwa kwa ma laboratories azachipatala kapena ogwira ntchito zachipatala kuti ayesedwe msanga, ndipo sangathe kugwiritsidwa ntchito poyesa kunyumba.

2. Mankhwalawa ndi oyenerera kuti azindikire mphuno ya munthu kapena zitsanzo za katulutsidwe ka mmero. Imazindikira zomwe zili mu virus muzotulutsa,

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