SARS-CoV-2 Antigen Assay Kit

SARS-CoV-2 Antigen Assay Kit

(Immunochromatography Method) Product Manual

【PRODUCT NAME】SARS-CoV-2 Antigen Assay Kit(Immunochromatography nzira)

【PACKAGING SPECIFICATIONS】1 Test/Kit ,25Tests/Kit, 100Tests/Kit

【ABSTRACT】

Iyo novel coronaviruses ndeye β genus. COVID-19 chirwere chekufema chinotapukira. Vanhu vanowanzo batwa nedambudziko iri. Parizvino, varwere vakatapukirwa neinoveli coronavirus ndiyo honzeri yehutachiona; asymptomatic vanhu vane hutachiona vanogona zvakare kuve nehutachiona sosi. Zvichienderana neazvino epidemiological kuferefeta, iyo incubation nguva ndeye 1 kusvika 14 mazuva, kazhinji 3 kusvika 7 mazuva. Zviratidzo zvikuru zvinosanganisira fivha, kuneta uye chikosoro chakaoma. Nasal congestion, runny mhino, kurwadziwa kwehuro, myalgia uye manyoka zvinowanikwa mune zvishoma.

【EXPECTED USAGE】

Kiti iyi inoshandiswa kuona zvine hunyanzvi kuona iyo novel coronaviruses (SARS-CoV-2) antigen mumhuno dzehuro swabs, oral pahuro swabs, posterior oropharyngeal mate, sputum uye stool samples.

Iyo chete yakakodzera kune inyanzvi in ​​vitro kuongororwa, kwete yekushandisa wega.

Ichi chigadzirwa chinongoshandiswa mumakiriniki marabhoritari kana kuongororwa nekukurumidza nevashandi vekurapa. Haikwanise kushandiswa pakuongorora kumba.

Iyo haigone kushandiswa sehwaro hwekuongororwa uye kusabvisa pneumonia inokonzerwa neinoveli coronaviruses (SARS-CoV-2) hutachiona. Haikodzeri kuongororwa neruzhinji rwevanhu.

Mhedzisiro yebvunzo yakanaka inoda kumwe kusimbiswa, uye mhinduro isina kunaka haigone kubvisa mukana wekutapukirwa.

Kiti uye mhinduro dzebvunzo ndezvekuongororwa kwekiriniki chete. Zvinokurudzirwa kuti zviratidzo zvekiriniki zvemurwere uye dzimwe ongororo dzemurabhoritari zvibatanidzwe kuti paongororwe zvizere mamiriro acho.Kiti haigone kusiyanisa pakati peSARS-CoV neSARS-CoV-2.

【PRINCIPLES OF THE PROCEDURE】

Ichi chigadzirwa chinotora colloidal goridhe immunochromatography tekinoroji, kupfapfaidza colloidal goridhe rakanyorwa SARS-CoV-2 mono-clonal antibody 1 pane yegoridhe padhi Iyo SARS-CoV-2 monoclonal antibody 2 yakaputirwa panitrocellulose membrane semutsara wekuyedza (T mutsara) uye mbudzi. anti-mouse IgG antibody yakaputirwa seyemhando yekudzora mutsara (C mutsara). Kana huwandu hwakakodzera hwemuenzaniso unoyedzwa wawedzerwa kune sampuli gomba rebvunzo kadhi, sampuro inoenda mberi nekadhi rekuyedza pasi pecapillary action. Kana sampuro iine SARS-CoV-2 antigen, antigen inosunga negoridhe recolloidal rakanzi SARS-CoV-2 monoclonal antibody 1, uye immune complex inoumba yakaoma neyakavharwa SARS-CoV-2 monoclonal antibody 2 pa T mutsetse, unoratidza yepepuru-tsvuku T mutsara, zvichiratidza kuti SARS-CoV-2 antigen yakanaka. Kana mutsetse wekuyedza T usingaratidze ruvara uye uchiratidza mhedzisiro, zvinoreva kuti sampuli haina SARS-CoV-2 antigen. Kadhi rekuedza rinewo mutsara wekutonga wehutano C, pasinei nokuti pane mutsara wekuedza, mutsara wepepuru-tsvuku wehutano C unofanirwa kuonekwa. Kana iyo yemhando yekudzora mutsara C isingaoneke, inoratidza kuti mhedzisiro yebvunzo haina kunaka, uye iyi sampuli inoda kuongororwa zvakare.

【MAIN COMPONENTS】

1.Test kadhi: Kadhi rekuyedza rine kadhi repurasitiki uye tambo yekuyedza. Mutambo wekuyedza wakagadzirwa ne nitrocellulose membrane (nzvimbo yekuona yakaputirwa neSARS-CoV-2 monoclonal antibody 2, nzvimbo yekudzora mhando yakaputirwa nembudzi antimouse IgG antibody), uye goridhe padhi (yakapfapfaidzwa negoridhe colloidal rakanyorwa SARS-CoV- 2 monoclonal antibody 1), sampuli pad, bepa rinonyura, uye PVC board.

2. Sample extraction solution: Buffer solution ine phosphate inoenderana nezvinodiwa zvekiti (pH6.5-8.0).

3. Sample extraction tube.

4. Kusabereka swab,kukwesha,mudziyo.

5. Manual.

Ongorora: Izvo zvikamu mumabheji akasiyana ekiti hazvigone kushandiswa zvakasiyana.

【STORAGE UYE EXPIRATION】

Iyo nguva yechokwadi ndeye 18 mwedzi kana chigadzirwa ichi chakachengetwa munzvimbo ye2 ℃-30 ℃.

Chigadzirwa chacho chinofanira kushandiswa mukati memaminitsi e15 kana bhegi refoil ravhurwa. Vhara chivharo pakarepo mushure mekutora sampuli yekubvisa mhinduro. Zuva rekugadzira uye zuva rekupera zvekushanda zvinoratidzwa pane iyo label.

【SAMPLE REQUIREMENTS】

1. Inoshanda pahuro yemunhu, swabs pahuro, posterior oropharyngeal mate, sputum uye zvimbudzi.

2. Sample collection:

( 1)Nasal secretion collection: Paunenge uchiunganidza mumhino, isa scleile swab panzvimbo inobuda zvakanyanya mumhino, shandura zvinyoro nyoro wosaidzira swab mumhino kusvika turbinate yavharika, wotenderedza swab katatu. nguva pamadziro emhino

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uye bvisa swab.

(2)Kuunganidzwa kwehuro pahuro: Isa chirairo muhuro zvachose kubva pamuromo, pakati pemadziro ehuro nenzvimbo yakatsvuka yemukanwa tonsils, pukuta mativi maviri epharyngeal tonsils uye posterior pharyngeal madziro nesimba riri pakati nepakati, dzivisa kubata rurimi. uye bvisa swab.

(3) Posterior oropharyngeal mate: Ita hutsanana hwemaoko nesipo nemvura /doro-based hand rub. Vhura mudziyo. Ita ruzha rweKruuua kubva pahuro kuti ubvise mate kubva pahuro yakadzika, wobva wapfira mate (anenge 2 ml) mumudziyo. Dzivisa chero kusvibiswa kwemate kwekunze kwegaba. Yakakwana nguva yekuunganidza yemuenzaniso: Mushure mekumuka uye usati wakwesha mazino, kudya kana kunwa.

3. Gadzirisa sampuli pakarepo nemuenzaniso wekubvisa mhinduro inopiwa mukiti mushure mokunge sampu yaunganidzwa. Kana isingakwanise kugadziriswa nekukasira, sampuli inofanira kuchengetwa muvhu rakaoma, sterilized uye rakavharwa zvakasimba epurasitiki chubhu. Inogona kuchengetwa pa2 ℃ -8 ℃ kwemaawa masere, uye inogona kuchengetwa kwenguva yakareba pa -70 ℃.

4. Mienzaniso yakasvibiswa zvakanyanya nemasara ezvokudya zvemuromo haigoni kushandiswa pakuongorora chigadzirwa ichi. Samples dzakaunganidzwa kubva kune swabs dzakanyanya viscous kana agglomerated hazvikurudzirwe kuongororwa chigadzirwa ichi. Kana iyo swabs yakasvibiswa nehuwandu hweropa, haina kukurudzirwa kuongororwa. Izvo hazvikurudzirwe kushandisa masampula akagadziriswa nesample yekubvisa mhinduro isina kupihwa mune ino kit yekuyedza chigadzirwa ichi.

【TESTING METHOD】

Ndapota verenga bhuku rekuraira zvakanyatsonaka usati waedza. Ndokumbira udzose mareagents kune tembiricha yekamuri pamberi pebvunzo. Muedzo unofanira kuitwa pakamuri tembiricha.

Edza Matanho:

1. Muenzaniso wekubvisa:

(1)Mate oropharyngeal ekumashure, sputum sample: wedzera 200ul sample yekubvisa mhinduro (inenge madonhwe matanhatu) muchubhu yekubvisa sampuli uye wotamisa inenge 200μL yemate matsva kana sputum kubva mumudziyo muSample Extraction Tube uye zunza uye sanganisa zvakakwana.

(2) Stool Sample: Vertically wedzera 200ul sample extraction solution (inenge madonhwe matanhatu) muchubhu yekubvisa sampuli, shandisa sampling rod kunhonga angangoita 30mg ezvituru zvitsva (Yakaenzana nehukuru hwemachisi musoro). Isa sampling tsvimbo muSample Extraction Tube uye zunza uye sanganisa zvachose kusvikira chituru chanyunguduka.

(3) Swabs sampuli: Vertically wedzera 500ul sampuli yekubvisa mhinduro (inenge madonhwe gumi nemashanu) mumuenzaniso wekubvisa chubhu. Isai swab yakaunganidzwa mumushonga muchubhu yekubvisa sampuli, woitenderedza pedyo nemadziro emukati mechubhu yebvunzo kanenge ka10 kuita kuti sampu inyunguduke mumushonga zvakanyanya sezvinobvira. Sveta musoro wetsvina uchitevedza madziro emukati mechubhu yekubvisa kuti mvura irambe iri muchubhu zvakanyanya sezvinobvira, bvisa uye urase swab. Ivhara chivharo.

2. Maitiro ekuonekwa:

( 1) Mushure mekunge kadhi rekuyedza radzokera kune tembiricha yekamuri, vhura bhegi realuminium foil uye tora kadhi rekuyedza woriisa rakachinjika padesktop.

(2) Wedzera 65ul (inenge madonhwe maviri) eiyo yakagadziriswa sampuli yakatorwa kana zvakananga kuwedzera 65ul (anenge madonhwe maviri) eiyo yakagadziriswa hutachiona sampling solution kune sampuli gomba rebvunzo kadhi.

(3) Verenga zvabuda mukati me15-30 maminetsi, uye zvawanikwa zvaverengwa mushure memaminitsi makumi matatu hazvishande.

【INTERPRETATION OF TEST RESULTS】

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【LIMITATION OF DETECTION METHOD】

1. Kuongororwa kwekliniki

Kuti vaongorore maitiro ekuongorora, chidzidzo ichi chakashandisa COVID-19-positive sampuli kubva kuvanhu mazana maviri nemakumi mashanu nevaviri uye COVID-19-negative sampuli kubva kuvanhu mazana matanhatu nemakumi masere nevatanhatu. Iyi mienzaniso yakaedzwa uye yakasimbiswa neRT-PCR nzira. Migumisiro yacho ndeiyi:

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

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

2. Muganho wekuona zvishoma:

Kana hutachiwana huripo hunopfuura 400TCID50/ml, chiyero chekutsvaga chakanaka chinodarika 95%. Kana hutachiwana huri pasi pe200TCID50/ml, chiyero chekutsvaga chakanaka chiri pasi pe95%, saka chidimbu chekutsvaga kwechigadzirwa ichi 400TCID50 / ml.

3. Kururamisa:

Mabheji matatu akateedzana emareagents akaedzwa kuti anyatso. Mabheji akasiyana emareagents akashandiswa kuyedza samu imwechete yakaipa 10 nguva dzakateedzana, uye mhedzisiro yese yaive yakaipa. Mabheji akasiyana emareagents akashandiswa kuyedza yakafanana yakanaka sampuli 10 nguva dzakateedzana, uye mhedzisiro yese yaive yakanaka.

4. HOOK maitiro:

Kana hutachiona huri mumuenzaniso uchaongororwa hunosvika 4.0 * 105TCID50/ml, mhedzisiro yebvunzo haisati yaratidza maitiro eHOOK.

5. Muchinjikwa-reactivity

Cross-reactivity yeKit yakaongororwa. Mhedzisiro yacho yakaratidza hapana kuchinjika reactivity nemuenzaniso unotevera.

6. Kupindira Zvinhu

Mhedzisiro yebvunzo haikanganiswe nechinhu ichi pane inotevera kuunganidzwa:

【LIMITATION OF DETECTION METHOD】

1. Ichi chigadzirwa chinongopihwa kumakiriniki marabhoritari kana vashandi vezvokurapa kuti vaedze nekukurumidza, uye haagone kushandiswa kuongororwa kumba.

2. Ichi chigadzirwa chakakodzerwa chete nekuonekwa kwemhuno yemunhu kana sampuli dzehuro secretion. Inoona hutachiona hwemukati mumuenzaniso wekubvisa,

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