SARS-CoV-2 Antigen Assay Kit (Immunochromatography Method)

SARS-CoV-2 Antigen Assay Kit

(Immunochromatography Method) Product Manual

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

【PACKAGING SPECIFICATIONS】1 Muedzo/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 iyo novel coronaviruses (SARS-CoV-2) antigen mumasamples emunhu mu vitro. 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.

【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) Kadhi rekuedza.

(2) Chinyorwa.

Ongorora: Izvo zvikamu mumabheji akasiyana ekiti hazvigone kushandiswa zvakasiyana.

【STORAGE AND 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, oral pahuro swabs, sample yemate.

2. Sample collection:

(1) Muunganidzwa wemate (YXN-SARS-AT-01): 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.Mate emuenzaniso(YXN-SARS-AT-01):

1

(2) Bvisa muromo wekaseti yebvunzo, nyudza kaseti yekuyedza mumate, kana kuisa kaseti tsvimbo pasi perurimi kwemaminetsi maviri.

(3) Chengetedza test cassette yakatwasuka uye rega mvura yemate ikwire kumusoro kusvika yasvika kana kufamba pamusoro peMutsetse C, wozodzosera chivharo woisa kaseti yebvunzo padhesiki.

(4) Verenga zvabuda mukati me15-30 maminetsi, uye zvabuda zvinoverengwa mushure memaminitsi makumi matatu hazvishande.

【[INTERPRETATION OF TEST RESULTS】

【LIMITATION OF DETECTION METHOD】

1. Kuongororwa kwekliniki

Kuti vaongorore mashandiro ekuongorora, chidzidzo ichi chakashandisa COVID-19-positive sampuli kubva kuvanhu zana nemakumi mashanu uye COVID-19-negative sampuli kubva kuvanhu mazana matatu nemakumi mashanu. Iyi mienzaniso yakaedzwa uye yakasimbiswa neRT-PCR nzira. Migumisiro yacho ndeiyi:

a) Sensitivity :92.67% (139/ 150), 95%CI (87.26%, 96.28%).

b) Kunyatsojeka: 98.29% ( 344 / 350), 95% CI ( 96.31%, 99.37%).

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 ka10 mukutevedzana, uye iyo

maresults aive akanaka.

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 pane inotevera concentration:

【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, zvisinei nekuti hutachiona hunotapukira. Naizvozvo, mhinduro dzebvunzo dzechigadzirwa ichi uye hutachiona hutsika mhedzisiro yemuyedzo imwechete inogona kunge isingawirirane.

3. Kadhi rekuedza uye sampuli yekubvisa mhinduro yechigadzirwa ichi inoda kudzorerwa kune tembiricha yekamuri isati yashandiswa. Tembiricha isina kufanira inogona kukonzera mhinduro isina kujairika.

4. Munguva yekuedzwa, mhinduro dzebvunzo dzinogona kusaenderana nemhedzisiro yekiriniki nekuda kwekusakwana kwemuenzaniso muunganidzwa we sterile swabs kana kuunganidza zvisina kufanira uye specimen extraction operation.

5. Panguva yekushandiswa kwechigadzirwa ichi, unoda kunyatsotevera matanho ekushanda ebhuku. Matanho ekushanda asina kunaka uye mamiriro ezvakatipoteredza anogona kukonzera mhedzisiro yebvunzo isina kujairika.

6. Iyo swab inofanira kutenderedzwa kanenge ka10 pamadziro emukati mechubhu yebvunzo ine mhinduro yekubvisa sampuli. Kutenderera kushoma kana kuwanda kunogona kukonzera bvunzo dzisina kujairika.

7. Mhedzisiro yakanaka yechigadzirwa ichi haigone kubvisa mukana wekuti mamwe hutachiona huve hwakanaka.

8. Mhedzisiro isina kunaka yekuongororwa kana chigadzirwa ichi hachigone kubvisa mukana wekuti mamwe hutachiona huve hwakanaka.

9. Negative test results inokurudzirwa kuti iongororwe ne nucleic acid yekuona reagents kudzivirira njodzi yekupotsa bvunzo.

10. Panogona kunge paine misiyano mumhedzisiro yebvunzo pakati pemakiriniki akaomeswa nechando uye achangobva kuunganidzwa ekiriniki samples.

.

12. Panguva yekushandiswa kwechigadzirwa ichi, chiyero chakakodzera chemuenzaniso chinodiwa, shoma kana yakawandisa sampuli yemari inogona kukonzera mhedzisiro yebvunzo isina kujairika. Zvinokurudzirwa kushandisa pipette ine yakanyatsojeka sampuli vhoriyamu yemuenzaniso wekuwedzera bvunzo.

【PRECAUTIONS】

1. Ndokumbira uenzanise sampuli diluent uye bvunzo kadhi kune tembiricha yekamuri (pamusoro pe30min) usati waedzwa.

2. Kuongorora kunofanira kuitwa zvakanyatsoenderana nemirairo.

3. Mhedzisiro inofanira kududzirwa mukati me15-30min, uye mugumisiro wakaverengwa mushure memaminitsi makumi matatu haugoneki.