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

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

【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 ainihin ƙwayar cuta ta coronaviruses (SARS-CoV-2) a cikin samfuran yau da kullun na ɗan adam a cikin vitro. 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.

【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) Katin gwaji.

(2) Manual.

Lura: Abubuwan da ke cikin batches daban-daban na kit ɗin ba za a iya amfani da su ba.

【STORAGE AND 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 amfani da shi ga ɗan adam hanci makogwaro swabs, na baka makogwaro swabs, saliva samfurin.

2. Tarin Misali:

( 1) Tarin saliva (YXN-SARS-AT-01): Yi tsaftar hannu da sabulu da ruwa / shafa hannu na tushen barasa. Bude kwandon. Yi ƙarar Kruuua daga makogwaro don share miyau daga zurfin makogwaro, sannan tofa miya (kimanin 2 ml) 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.Saliva samfurin (YXN-SARS-AT-01):

( 1) Bayan kaset ɗin gwajin ya dawo cikin ɗaki, buɗe jakar foil na aluminum sannan a fitar da kaset ɗin gwajin sannan a sanya shi a kwance akan tebur.

(2) Cire titin kaset ɗin gwajin, nutsar da kaset ɗin gwajin a cikin miya, ko sanya sandar kaset ɗin gwajin ƙasan harshe na tsawon mintuna 2.

(3) A ajiye kaset ɗin gwajin a tsaye sannan a bar ruwan miya ya motsa sama har sai ya kai ko ya wuce layin C, sannan a mayar da murfin sannan a ajiye kaset ɗin gwajin akan tebur.

(4) Karanta sakamakon da aka nuna a cikin mintuna 15-30, kuma sakamakon da aka karanta bayan mintuna 30 ba shi da inganci.

【[INTERPRETATION OF TEST RESULTS】

【LIMITATION OF GANEION METHOD】

1. Tabbatarwa na asibiti

Don kimanta aikin bincike, wannan binciken ya yi amfani da samfuran COVID-19-tabbatacce daga mutane 150 da samfuran COVID-19-mara kyau daga mutane 350. An gwada waɗannan samfuran kuma an tabbatar da su ta hanyar RT-PCR. Sakamakon kamar haka:

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

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

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, da kuma

Sakamakon duka yana da kyau.

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.

6. Abubuwan Tsangwama

Sakamakon gwajin ba zai shiga tsakani da abun a cikin taro mai zuwa ba:

【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 abubuwan da ke cikin kwayar cutar a cikin samfurin, 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. Sakamakon gwaji mara kyau f wannan samfurin ba zai iya yin watsi da yiwuwar sauran ƙwayoyin cuta su kasance masu inganci ba.

9. Ana ba da shawarar sakamakon gwajin mara kyau don tabbatar da su tare da abubuwan gano abubuwan gano acid nucleic don guje wa haɗarin gwajin da aka rasa.

10. Ana iya samun bambance-bambance a cikin sakamakon gwaji tsakanin daskararrun samfuran asibiti da sabbin samfuran asibiti da aka tattara.

11. 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.

12. 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.

【PRECAUTIONS】

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.