SARS-CoV-2 Antigen Assay Kit
SARS-CoV-2 Antigen Assay Kit
(Immunochromatography Method) Product Manual
【PRUDUCT NAME】SARS-CoV-2 Antigen Assay Kit(Hanyar Immunochromatography)
【PACKAGING SPECIFICATIONS】1 Gwaji/Kit, 25 Gwaji/Kit, Gwaji 100/Kit
【ABSTRACT】
Novel coronaviruses na cikin nau'in β. COVID-19 cuta ce mai saurin kamuwa da numfashi. Mutane gabaɗaya suna da sauƙi. A halin yanzu, marasa lafiya da suka kamu da cutar sankara ta coronavirus sune babban tushen kamuwa da cuta; Mutanen da suka kamu da asymptomatic suma suna iya zama tushen kamuwa da cuta. Dangane da binciken cututtukan cututtuka na yanzu, lokacin shiryawa shine kwanaki 1 zuwa 14, galibi daga kwanaki 3 zuwa 7. Babban bayyanar cututtuka sun haɗa da zazzabi, gajiya da bushewar tari. Ana samun cunkoso na hanci, hanci, ciwon makogwaro, myalgia da gudawa a wasu lokuta.
【EXPECTED USAGE】
Ana amfani da wannan kit ɗin don gano sabon coronaviruses (SARS-CoV-2) antigen a cikin swabs na hanci na ɗan adam, swabs na makogwaro, ƙoshin oropharyngeal na baya, sputum da samfuran stool.
Ya dace kawai don ƙwararrun bincike na in vitro, ba don amfanin mutum ba.
Ana amfani da wannan samfurin ne kawai a dakunan gwaje-gwaje na asibiti ko gwajin gaggawa ta ma'aikatan lafiya. Ba za a iya amfani da shi don gwajin gida ba.
Ba za a iya amfani da shi azaman tushen ganewar asali da keɓance cutar huhu da ke haifar da cututtukan coronaviruses (SARS-CoV-2) ba. Bai dace da tantancewa ta yawan jama'a ba.
Sakamakon gwaji mai kyau yana buƙatar ƙarin tabbaci, kuma sakamakon gwaji mara kyau ba zai iya kawar da yiwuwar kamuwa da cuta ba.
Kit ɗin da sakamakon gwajin na asibiti ne kawai. Ana ba da shawarar cewa a haɗa bayyanar cututtuka na marasa lafiya da sauran gwaje-gwajen dakin gwaje-gwaje don cikakken nazarin yanayin. Kayan ba zai iya bambanta tsakanin SARS-CoV da SARS-CoV-2 ba.
【PRINCIPLES OF THE PROCEDURE】
Wannan samfurin yana ɗaukar fasahar immunochromatography na gwal na colloidal, yana fesa zinare colloidal mai lakabin SARS-CoV-2 mono-clonal antibody 1 akan kushin gwal The SARS-CoV-2 monoclonal antibody 2 an lullube shi akan membrane na nitrocellulose azaman layin gwaji (T line) da akuya. Anti-mouse IgG antibody an lullube shi azaman layin sarrafa inganci (layin C). Lokacin da adadin da ya dace na samfurin da za a gwada ya ƙara zuwa ramin samfurin katin gwajin, samfurin zai ci gaba tare da katin gwajin a ƙarƙashin aikin capillary. Idan samfurin ya ƙunshi antigen na SARS-CoV-2, antigen ɗin zai ɗaure tare da zinare na zinari mai lakabin SARS-CoV-2 monoclonal antibody 1, kuma hadaddun rigakafin yana haifar da hadaddun tare da rufin SARS-CoV-2 monoclonal antibody 2 a Layin T, yana nuna layin T mai shuɗi-ja, yana nuna cewa SARS-CoV-2 antigen yana da inganci. Idan layin gwajin T bai nuna launi ba kuma yana nuna mummunan sakamako, yana nufin samfurin bai ƙunshi antigen SARS-CoV-2 ba. Katin gwajin kuma yana ƙunshe da layin sarrafa inganci, ko da akwai layin gwaji, layin kula da ingancin ingancin ja-ja-jaya ya kamata ya bayyana. Idan layin kula da ingancin C bai bayyana ba, yana nuna cewa sakamakon gwajin ba daidai ba ne, kuma wannan samfurin yana buƙatar sake gwadawa.
【MAIN COMPONENTS】
1.Test Card: Katin gwajin yana kunshe da katin filastik da na'urar gwaji. An yi tsirin gwajin da nitrocellulose membrane (yankin ganowa an lullube shi da SARS-CoV-2 monoclonal antibody 2, yankin kula da ingancin yana da rufin goat antimouse IgG antibody), da kushin gwal (fesa da zinare colloidal mai lakabin SARS-CoV- 2 monoclonal antibody 1), samfurin kushin, takarda mai sha, da allon PVC.
2. Samfurin cirewar samfurin: Maganin buffer wanda ya ƙunshi phosphate daidai da ƙayyadaddun kayan aiki (pH6.5-8.0).
3. Samfurin hakar bututu.
4. Bakararre swab, shafa, kwantena.
5. Manual.
Lura: Abubuwan da ke cikin batches daban-daban na kit ɗin ba za a iya amfani da su ba.
| Cat. No. | YXN-SARS-AT-01 | YXN-SARS-AT-25 | YXN-SARS-AT-100 |
| Package Specifications | 1 test/kit | 25 tests/kit | 100 tests/kit |
| Maganin hakar samfurin | 1 ml / kwalba | 5ml/kwalba*6 kwalabe | 5mL / kwalban * 24 kwalabe |
| Samfurin hakar bututu | 1 gwaji* fakiti 1 | ≥25 gwaje-gwaje* 1 fakitin | ≥25 gwaje-gwaje* 4 fakiti |
| manual | guda 1 | guda 1 | guda 1 |
【STORAGE KUMA EXPIRATION】
Lokacin tabbatarwa shine watanni 18 idan an adana wannan samfurin a cikin yanayin 2 ℃-30 ℃.
Ya kamata a yi amfani da samfurin a cikin minti 15 da zarar an buɗe jakar jakar. Rufe murfin nan da nan bayan cire samfurin cirewar samfurin. Ana yin la'akari da kwanan watan samarwa da ranar karewa akan alamar.
【SAMPLE REQUIREMENTS】
1. Ana iya amfani da swabs na hancin makogwaro na mutum, swabs na makogwaro, jijiyar oropharyngeal na baya, sputum da samfurori na stool.
2. Tarin Misali:
( 1) Tarin hanci: Lokacin da za a tattara ruwan hanci, sai a sanya swab mai bakararre a cikin inda jini ya fi yawa a cikin hancin, a hankali a juya a tura shi cikin kogon hancin har sai an toshe turbinate, sannan a jujjuya swab uku. sau a bango na kogon hanci
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kuma fitar da swab.
(2)Tarin sigar maƙogwaro: Saka swab maras kyau a cikin makogwaro gaba ɗaya daga baki, yana maido da bangon makogwaro da wurin jajayen tonsils na palate, goge tonsils na pharyngeal biyu da bangon pharyngeal na baya tare da matsakaicin ƙarfi, guje wa taɓa harshe. kuma fitar da swab.
(3) Maganganun bakin ciki na baya: Yi tsaftar hannu da sabulu da ruwa / shafa hannu na tushen barasa. Bude kwandon. Yi ƙarar Kruuua daga makogwaro don share ɗigon daga maƙogwaro mai zurfi, sa'an nan kuma tofa miya (kimanin 2 ml) a cikin akwati. Ka guje wa duk wani gurɓatawar miyagu na saman kwandon. Mafi kyawun lokacin tattara samfuran ： Bayan tashi da kuma kafin goge haƙora, ci ko sha.
3. Gudanar da samfurin nan da nan tare da samfurin cirewar samfurin da aka bayar a cikin kit bayan an tattara samfurin. Idan ba za a iya sarrafa shi nan da nan ba, samfurin ya kamata a adana shi a bushe, haifuwa da bututun filastik da aka rufe sosai. Ana iya adana shi a 2 ℃ -8 ℃ na tsawon sa'o'i 8, kuma ana iya adana shi na dogon lokaci a -70 ℃.
4. Samfuran da suka gurɓata sosai ta ragowar abinci na baka ba za a iya amfani da su don gwada wannan samfurin ba. Samfuran da aka tattara daga swabs waɗanda ke da ɗan ƙoƙon ƙoƙo ko ƙaranci ba a ba da shawarar gwada wannan samfurin ba. Idan swabs sun gurbata da adadi mai yawa na jini, ba a ba da shawarar su don gwaji ba. Ba a ba da shawarar yin amfani da samfuran da aka sarrafa tare da samfurin hakar samfurin da ba a bayar da su a cikin wannan kit ɗin don gwada wannan samfurin ba.
【TESTING METHOD】
Da fatan za a karanta littafin koyarwa a hankali kafin gwaji. Da fatan za a mayar da duk reagents zuwa zafin jiki kafin gwajin. Ya kamata a yi gwajin a cikin zafin jiki.
Matakan Gwaji:
1. Samfuran Cire:
( 1) Maganin oropharyngeal na baya, samfurin sputum: a tsaye ƙara 200ul samfurin cirewa (kimanin 6 saukad) a cikin bututun cire samfurin kuma canza kusan 200μL na sabo ko sputum daga akwati a cikin Samfurin Extraction Tube kuma girgiza da haɗuwa gaba ɗaya.
(2) Stool Samfurin: A tsaye ƙara 200ul samfurin hakar bayani (kimanin 6 saukad da) a cikin samfurin hakar bututu, yi amfani da samfurin sanda karba kusan 30mg na sabo stool samfurori (daidai da girman kai a wasa). Sanya sandar samfurin a cikin Samfurin Cire Tube sannan a girgiza kuma a gauraya gaba daya har sai duk stool ya narke.
(3) Swabs samfurin: A tsaye ƙara 500ul samfurin hakar bayani (kimanin 15 saukad da) a cikin samfurin hakar bututu. Saka swab ɗin da aka tattara a cikin bayani a cikin bututun cire samfurin, kuma juya shi kusa da bangon ciki na bututun gwajin kamar sau 10 don sa samfurin ya narke a cikin bayani gwargwadon yiwuwa. Matse kan swab na swab tare da bangon ciki na bututun hakar don kiyaye ruwa a cikin bututu gwargwadon yiwuwa, cirewa kuma jefar da swab. Rufe murfin.
2. Hanyoyin ganowa:
( 1) Bayan katin gwajin ya dawo dakin da zafin jiki, bude jakar foil na aluminum sannan a fitar da katin gwajin sannan a sanya shi a kwance akan tebur.
(2) Ƙara 65ul (kimanin digo 2) na samfurin da aka sarrafa ko ƙara 65ul (kimanin digo 2) na maganin ƙwayar cuta da aka sarrafa zuwa samfurin katin gwajin.
(3) Karanta sakamakon da aka nuna a cikin mintuna 15-30, kuma sakamakon da aka karanta bayan mintuna 30 ba shi da inganci.
【IFASSARAION OF TEST RESULTS】
| ★Layin gwajin (T) da layin sarrafawa (C) suna nuna madaurin launi kamar yadda hoton ya nuna daidai, wanda ke nuna cewa SARS-CoV-2 antigen yana da inganci. | |
| ★NAGATIVE: Idan kawai layin kula da ingancin C yana haɓaka launi kuma layin gwajin (T) baya haɓaka launi, ba a gano antigen SARSCoV-2 ba kuma sakamakon yana da kyau, kamar yadda hoton ya nuna daidai. | |
| ★INVALID: Babu bandeji mai launi da ke bayyana akan layin ingancin ingancin (C), kuma ana yin hukunci a matsayin sakamako mara inganci ba tare da la'akari da layin ganowa (T) ya nuna band ɗin launi ba ko a'a, kamar yadda hoton ya nuna daidai. Layin sarrafawa ya kasa bayyana.Rashin ƙarar samfurin ko dabarun tsari da ba daidai ba shine mafi kusantar dalilai na gazawar layin sarrafawa.Bita tsarin kuma maimaita gwajin tare da sabon kaset ɗin gwaji.Idan matsalar ta ci gaba, daina amfani da kayan gwajin nan da nan kuma tuntuɓi ku. local distributor.Standard Laboratory Practice (GLP) dakunan gwaje-gwaje ana ba da shawarar don gudanar da ingancin kulawa daidai da hanyoyin aikin dakin gwaje-gwaje a ƙarƙashin jagorancin dokokin ƙasa ko na gida. |
2
【LIMITATION OF GANEION METHOD】
1. Tabbatarwa na asibiti
Don kimanta aikin gano cutar, wannan binciken ya yi amfani da samfuran COVID-19-tabbatacce daga mutane 252 da samfuran COVID-19-mara kyau daga mutane 686. An gwada waɗannan samfuran kuma an tabbatar da su ta hanyar RT-PCR. Sakamakon kamar haka:
a) Hankali: 95.24% (240/252), 95% CI (91.83%, 97.52%)
b) Musamman: 99. 13% (680/686), 95% CI (98. 11%, 99.68%)
2. Iyakar ganowa mafi ƙarancin:
Lokacin da abun cikin kwayar cutar ya fi 400TCID50/ml, ƙimar ganowa mai inganci ya fi 95%. Lokacin da abun cikin kwayar cutar ya kasance ƙasa da 200TCID50/ml, ƙimar ganowa mai inganci bai wuce 95% ba, don haka mafi ƙarancin gano wannan samfurin shine 400TCID50/ml.
3. Daidaito:
An gwada batches uku a jere na reagents don daidaito. An yi amfani da batches daban-daban na reagents don gwada samfurin mara kyau sau 10 a jere, kuma sakamakon duka mara kyau ne. An yi amfani da batches daban-daban na reagents don gwada samfurin tabbatacce sau 10 a jere, kuma sakamakon duka tabbatacce ne.
4. Tasirin HOOK:
Lokacin da abun ciki na ƙwayar cuta a cikin samfurin da za a gwada ya kai 4.0*105TCID50/ml, sakamakon gwajin har yanzu bai nuna tasirin HOOK ba.
5. Cross-reactivity
An ƙididdige sake kunnawar Kit ɗin. Sakamako ya nuna babu giciye mai aiki tare da samfurori masu zuwa.
| A'a. | Abu | Conc. | A'a. | Abu | Conc. |
| 1 | HCOV-HKU1 | 105TCID50/ml | 16 | Mura A H3N2 | 105TCID50/ml |
| 2 | Staphylococcus aureus | 106TCID50/ml | 17 | H7N9 | 105TCID50/ml |
| 3 | Rukunin A streptococci | 106TCID50/ml | 18 | H5N1 | 105TCID50/ml |
| 4 | Kwayar cutar kyanda | 105TCID50/ml | 19 | Epstein-Barr cutar | 105TCID50/ml |
| 5 | Cutar mumps | 105TCID50/ml | 20 | Enterovirus CA16 | 105TCID50/ml |
| 6 | Adenovirus nau'in 3 | 105TCID50/ml | 21 | Rhinovirus | 105TCID50/ml |
| 7 | Mycoplasmal ciwon huhu | 106TCID50/ml | 22 | Ƙwayar cutar da ke kama huhu | 105TCID50/ml |
| 8 | Paraimfluenzavirus, nau'in 2 | 105TCID50/ml | 23 | Streptococcus pneumoniae | 106TCID50/ml |
| 9 | Mutum metapneumovirus | 105TCID50/ml | 24 | Candida albicans | 106TCID50/ml |
| 10 | Mutum coronavirus OC43 | 105TCID50/ml | 25 | Chlamydia pneumoniae | 106TCID50/ml |
| 11 | Mutum coronavirus 229E | 105TCID50/ml | 26 | Bordetella pertussis | 106TCID50/ml |
| 12 | Bordetella parapertusosis | 106TCID50/ml | 27 | Pneumocystis jijiya | 106TCID50/ml |
| 13 | Cutar mura B Victoria iri | 105TCID50/ml | 28 | Mycobacterium tubercu hasara | 106TCID50/ml |
| 14 | Mura B Y iri | 105TCID50/ml | 29 | Legionella pneumophila | 106TCID50/ml |
| 15 | mura A H1N1 2009 | 105TCID50/ml |
6. Abubuwan Tsangwama
Sakamakon gwajin ba za a tsoma baki tare da abun da ke cikin abubuwan da ke gaba ba:
| A'a. | Abu | Conc. | A'a. | Abu | Conc. |
| 1 | Dukan Jini | 4% | 9 | Mucin | 0.50% |
| 2 | Ibuprofen | 1 mg/ml | 10 | Benzoin Gel | 1.5mg/ml |
| 3 | tetracycline | 3 ug/ml | 11 | Cromolyn glycate | 15% |
| 4 | chloramphenicol | 3 ug/ml | 12 | Deoxyepinephrine hydro chloride | 15% |
| 5 | Erythromycin | 3 ug/ml | 13 | Afrin | 15% |
| 6 | Tobramycin | 5% | 14 | Fluticasone propionate | 15% |
| 7 | Oseltamivir | 5mg/ml | 15 | menthol | 15% |
| 8 | Naphazoline Hydrochloro hawan Hanci Drops | 15% | 16 | Mupirocin | 10mg/ml |
【LIMITATION OF GANEION METHOD】
1. Wannan samfurin ana ba da shi ne kawai ga dakunan gwaje-gwaje na asibiti ko ma'aikatan lafiya don gwaji nan take, kuma ba za a iya amfani da shi don gwajin gida ba.
2. Wannan samfurin ya dace kawai don gano kogon hanci na ɗan adam ko samfuran ɓoye maƙogwaro. Yana gano abun ciki na ƙwayoyin cuta a cikin abin da aka cire samfurin,
3
ba tare da la'akari da ko kwayar cutar ba ce. Don haka, sakamakon gwajin wannan samfur da sakamakon al'adun ƙwayoyin cuta na samfurin iri ɗaya na iya zama ba za a haɗa su ba.
3. Katin gwajin da samfurin hakar samfurin wannan samfurin yana buƙatar a mayar da shi zuwa zafin jiki kafin amfani. Rashin zafin jiki na iya haifar da sakamako mara kyau.
4. A lokacin aikin gwaji, sakamakon gwajin bazai dace da sakamakon asibiti ba saboda rashin isasshen samfurin tarin swabs mara kyau ko tarawa mara kyau da aikin cire samfurin.
5. Yayin amfani da wannan samfurin, kuna buƙatar bin matakan aiki na littafin. Matakan aiki mara kyau da yanayin muhalli na iya haifar da sakamako mara kyau na gwaji.
6. Ya kamata a jujjuya swab kusan sau 10 akan bangon ciki na bututun gwaji wanda ke dauke da maganin cirewar samfurin. Juyawa kaɗan ko yawa na iya haifar da sakamako mara kyau na gwaji.
7. Sakamakon sakamako mai kyau na wannan samfurin ba zai iya yin watsi da yiwuwar sauran kwayoyin cutar ba.
8. Kyakkyawan sakamakon gwajin wannan samfurin ba zai iya bambanta tsakanin SARS-CoV da SARS-CoV-2 ba.
9. Sakamakon gwaji mara kyau f wannan samfurin ba zai iya yin watsi da yiwuwar sauran ƙwayoyin cuta su kasance masu kyau ba.
10. Ana ba da shawarar sakamakon gwaji mara kyau don tabbatar da su tare da abubuwan gano abubuwan gano acid nucleic don guje wa haɗarin gwajin da aka rasa.
11. Za a iya samun bambance-bambance a sakamakon gwajin tsakanin daskararrun samfuran asibiti da sabbin samfuran asibiti da aka tattara.
12. Ya kamata a gwada samfurin nan da nan bayan an tattara shi don guje wa sakamakon gwajin da ba a saba ba bayan an bar shi ya daɗe.
13. Yayin amfani da wannan samfurin, adadin samfurin da ya dace ya zama dole, kadan ko yawan adadin samfurin na iya haifar da sakamakon gwaji mara kyau. Ana ba da shawarar yin amfani da pipette tare da mafi girman samfurin samfurin don gwajin ƙari.
【KYAUTATAIONS】
1. Da fatan za a daidaita samfurin diluent da katin gwaji zuwa zafin jiki (sama da 30min) kafin gwaji.
2. Ya kamata a gudanar da bincike mai tsanani daidai da umarnin.
3. Dole ne a fassara sakamakon a cikin 15-30minti, kuma sakamakon da aka karanta bayan 30 min ba shi da inganci.
4. Ya kamata a yi la'akari da samfurin gwajin a matsayin abu mai cutarwa, kuma dole ne a gudanar da aikin daidai da ƙayyadaddun aiki na dakin gwaje-gwajen cututtuka, tare da matakan kariya da kulawa ga aikin kare lafiyar halittu.
5. Wannan samfurin ya ƙunshi abubuwa da aka samo daga dabba. Ko da yake ba mai yaduwa ba ne, ya kamata a kula da shi da taka tsantsan yayin da ake kula da hanyoyin kamuwa da cuta. Masu amfani yakamata su ɗauki matakan kariya don tabbatar da amincin kansu da sauran su.
6. Katunan gwajin da aka yi amfani da su, samfuran samfuri, da dai sauransu ana ɗaukar su azaman sharar ilimin likitanci bayan gwajin, kuma a wanke hannuwanku cikin lokaci.
7. Idan samfurin maganin maganin wannan samfurin ya zube cikin fata ko idanu da gangan, da fatan za a wanke nan da nan da ruwa mai yawa, kuma nemi kulawar likita idan ya cancanta.
8. Kada a yi amfani da kit ɗin tare da lalacewa bayyananne, da katin gwaji tare da fakitin lalacewa.
9. Wannan samfurin samfurin amfani ne na lokaci ɗaya, don Allah kar a sake amfani da shi, kuma kar a yi amfani da samfuran da suka ƙare.
10. Guji hasken rana kai tsaye da busa kai tsaye daga fanfunan lantarki yayin gwaji.
11. Ba za a iya amfani da ruwan famfo, ruwa mai ɗorewa ko ruwa da abin sha ba za a iya amfani da shi azaman reagents mara kyau.
12. Saboda bambancin samfurori, wasu layin gwaji na iya zama haske ko launin toka a launi. A matsayin samfurin inganci, idan dai akwai band a matsayi na layin T, ana iya yanke hukunci a matsayin tabbatacce.
13. Idan gwajin ya tabbata, ana ba da shawarar yin amfani da wannan katin gwajin don sake dubawa sau ɗaya don guje wa ƙananan abubuwan yuwuwa.
14. Akwai mai desiccant a cikin jakar foil na aluminum, kar a ɗauka da baki
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