Ngwa SARS-CoV-2 Antigen Assay

SARS-CoV-2 Antigen Assay Kit

(Immunochromatography Method) Product Manual

【PRODUCT NAME】Ngwa SARS-CoV-2 Antigen Assay(Usoro immunochromatography)

【PACKAGING SPECIFICAATIONS】1 Nnwale/Kit, 25Nnwale/Kit, 100Nleba/Kit

【ABSTRACT】

Akwụkwọ akụkọ coronaviruses bụ nke β genus. COVID-19 bụ nnukwu ọrịa na-efe efe nke iku ume. Ndị mmadụ na-adịkarị mfe. Ugbu a, ndị ọrịa bu ọrịa coronavirus ọhụrụ bụ isi ihe na-ebute ọrịa; ndị butere ọrịa asymptomatic nwekwara ike bụrụ ebe na-efe efe. Dabere na nyocha ọrịa na-efe efe ugbu a, oge nnabata bụ ụbọchị 1 ruo 14, ọkachasị ụbọchị 3 ruo 7. Ihe ngosi ndị bụ isi gụnyere ahụ ọkụ, ike ọgwụgwụ na ụkwara akọrọ. A na-ahụ mkpọchi imi, imi na-agba agba, akpịrị akpịrị, myalgia na afọ ọsịsa n'ọnọdụ ole na ole.

【EXPECTED USAGE】

A na-eji ngwa a achọpụta nke ọma coronaviruses ọhụrụ (SARS-CoV-2) antigen na imi akpịrị mmadụ, akpịrị akpịrị, swabs nke azụ oropharyngeal, sputum na stool samples.

Ọ dị mma naanị maka ọkachamara in vitro nchoputa, ọ bụghị maka ojiji nkeonwe.

A na-eji ngwaahịa a naanị na ụlọ nyocha ụlọ ọgwụ ma ọ bụ nyocha ozugbo site n'aka ndị ọrụ ahụike. Enweghị ike iji ya mee nyocha ụlọ.

Enweghị ike iji ya dị ka ihe ndabere maka nchọpụta na mwepu nke oyi baa n'ihi ọrịa coronavirus ọhụrụ (SARS-CoV-2). Ọ dịghị mma maka nyocha nke ọha mmadụ.

Nsonaazụ ule dị mma chọrọ nkwenye ọzọ, na nsonaazụ ule na-adịghị mma enweghị ike iwepụ ohere nke ibute ọrịa.

Ngwa na nsonaazụ ule bụ maka ntụnye aka ụlọọgwụ naanị. A na-atụ aro ka ejikọta ihe ngosi ụlọ ọgwụ nke onye ọrịa na nyocha ụlọ nyocha ndị ọzọ maka nyocha zuru oke nke ọnọdụ ahụ. Ngwa ahụ enweghị ike ịmata ọdịiche dị n'etiti SARS-CoV na SARS-CoV-2.

【PRINCIPLES OF THE PROCEN'OGEE】

Ngwaahịa a na-anabata teknụzụ immunochromatography gold colloidal, na-efesa ọla edo colloidal akpọrọ SARS-CoV-2 mono-clonal antibody 1 na pad ọla edo A na-ekpuchi SARS-CoV-2 monoclonal antibody 2 na akpụkpọ anụ nitrocellulose dị ka ahịrị ule (T line) na ewu. A na-ekpuchi mgbochi òké IgG mgbochi dị ka ahịrị njikwa mma (akara C). Mgbe agbakwunyere ego kwesịrị ekwesị nke ihe nlele a ga-anwale na oghere nlele nke kaadị ule ahụ, ihe nlele ahụ ga-aga n'ihu na kaadị ule n'okpuru ọrụ capillary. Ọ bụrụ na ihe nlele ahụ nwere antigen SARS-CoV-2, antigen ga-ejikọta ya na ọla edo colloidal akpọrọ SARS-CoV-2 monoclonal antibody 1, yana mgbagwoju ahụ na-alụso ọrịa ọgụ na-etolite mgbagwoju anya na SARS-CoV-2 monoclonal antibody 2. T ahịrị, na-egosi ahịrị T na-acha odo odo-acha ọbara ọbara, na-egosi na SARS-CoV-2 antigen dị mma. Ọ bụrụ na ahịrị ule T egosighi agba ma gosipụta nsonaazụ na-adịghị mma, ọ pụtara na nlele ahụ enweghị antigen SARS-CoV-2. Kaadị ule ahụ nwekwara ahịrị njikwa mma C, n'agbanyeghị ma enwere akara ule, ahịrị njikwa àgwà na-acha odo odo-acha ọbara ọbara kwesịrị ịpụta. Ọ bụrụ na ahịrị njikwa mma C apụtaghị, ọ na-egosi na nsonaazụ nnwale ahụ ezighi ezi, na ihe nlele a kwesịrị ịnwale ọzọ.

【MAIN COMPONENTS】

1.Test kaadị: The ule kaadị bụ ihe mejupụtara a plastic kaadị na a ule warara. A na-eji akpụkpọ anụ nitrocellulose mee ihe nnwale ahụ (ebe a na-achọpụta ebe a na-eji SARS-CoV-2 monoclonal antibody 2, ebe a na-achịkwa mma bụ ihe mgbochi ewu IgG antibody), na pad ọla edo (nke ejiri ọla kọlloidal nke akpọrọ SARS-CoV- fesa). 2 monoclonal mgbochi 1), pad sample, akwụkwọ na-amị amị, na bọọdụ PVC.

2. Ngwọta mmịpụta ihe atụ: Ngwọta nchekwa nwere phosphate kwekọrọ na nkọwapụta nke ngwa (pH6.5-8.0).

3. Ihe atụ nke mmịpụta tube.

4. Swab na-adịghị mma, ete, akpa.

5. Akwụkwọ ntuziaka.

Rịba ama: Enweghị ike iji ihe ndị dị na batches nke ngwa dị iche iche emekọrịta ihe.

【STORAGE NA EXPIRATION】

Oge nkwado bụ ọnwa 18 ma ọ bụrụ na echekwara ngwaahịa a na gburugburu 2℃-30℃.

Ekwesịrị iji ngwaahịa a mee ihe n'ime nkeji 15 ozugbo emeghere akpa foil. Kpuchie mkpuchi ozugbo ị wepụtachara ihe ngwọta mmịpụta sample. Edebere ụbọchị mmepụta na ụbọchị njedebe na label.

【SAMPLE REQUIREMENTS】

1. Ọdabara na mmadụ imi akpịrị swabs, ọnụ akpịrị swabs, posterior oropharyngeal asu, sputum na stool samples.

2. Nchịkọta ihe atụ:

( 1) Mkpokọta secretion nke imi: Mgbe ị na-achịkọta ihe nzuzo nke imi, tinye swab na-adịghị mma n'ime ebe nzuzo kachasị na oghere imi, jiri nwayọọ tụgharịa ma tinye swab ahụ n'ime oghere imi ruo mgbe a kwụsịrị turbinate, ma gbanwee swab atọ. ugboro megide mgbidi nke oghere imi

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ma wepụ swab ahụ.

(2) Mkpokọta nzuzo nke akpịrị: Fanye swab na-adịghị mma n'ime akpịrị kpamkpam site n'ọnụ, na-adabere na mgbidi akpịrị na ebe na-acha uhie uhie nke tonsils palate, hichaa tonsils pharyngeal bilateral na mgbidi pharyngeal azụ na ike dị oke ala, zere imetụ ire. ma wepụ swab ahụ.

(3) Asụ mmiri oropharyngeal nke dị n'azụ: Jiri ncha na mmiri / mmanya na-egbu egbu mee ịdị ọcha aka. Mepee akpa ahụ. Mee mkpọtụ Kruuua site na akpịrị iji kpochapụ mmiri mmiri site na akpịrị miri emi, wee gbụọ mmiri mmiri (ihe dịka 2 ml) n'ime akpa ahụ. Zenarị mmetọ mmiri ọ bụla nke elu elu nke akpa ahụ. Oge kacha mma nke nchịkọta ihe atụ: Mgbe ebilichara na tupu ịsa ezé, rie ma ọ bụ ịṅụ ihe ọṅụṅụ.

3. Hazie ihe nlele ozugbo na ihe ngwọta mmịpụta nke enyere na ngwa ahụ mgbe anakọtara ihe nlele ahụ. Ọ bụrụ na enweghị ike ịhazi ya ozugbo, a ga-echekwa ihe nlele ahụ n'ime akpa rọba kpọrọ nkụ, sterilized na nke mechiri emechi. Enwere ike ịchekwa ya na 2 ℃ -8 ℃ maka awa 8, enwere ike ịchekwa ya ogologo oge na -70 ℃.

4. Enweghị ike iji ihe nlere anya emeru nke ukwuu site na nsị nri ọnụ maka ịnwale ngwaahịa a. A naghị atụ aro nlele anakọtara site na swabs nke nwere viscous ma ọ bụ agglomerated maka nnwale ngwaahịa a. Ọ bụrụ na ejiri nnukwu ọbara merụọ swabs ahụ, a naghị atụ aro ya maka nyocha. A naghị atụ aro ka iji nlere anya nke ejiri ngwọta mmịpụta nlele ewepụtaghị na ngwa a maka ịnwale ngwaahịa a.

【TESTING METHOD】

Biko jiri nlezianya gụọ ntuziaka ntuziaka tupu ịnwale. Biko weghachite reagents niile n'ime ụlọ okpomọkụ tupu ule ahụ. Ekwesịrị ime ule ahụ na okpomọkụ ụlọ.

Usoro ule:

1. Ihe nlele:

(1) Asụ oropharyngeal azụ, sputum sample: Tinye n'ezie 200ul sample mmịpụta ihe ngwọta (ihe dị ka 6 tụlee) n'ime tube mmịpụta ihe atụ wee bufee ihe dịka 200μL nke mmiri ọhụrụ ma ọ bụ sputum sitere na akpa n'ime tube Extraction Tube wee maa jijiji na mix kpamkpam.

(2) Stool Sample: tinye n'ụzọ kwụ ọtọ 200ul sample mmịpụta ngwọta (ihe dị ka 6 tụlee) n'ime sample mmịpụta tube, na-eji ihe nlele mkpara na-eburu ihe dị ka 30mg nke ọhụrụ stool samples (Ekwetara na size nke a egwuregwu isi). Tinye mkpanaka nlele n'ime tube Extraction nke Sample ma maa jijiji ma gwakọta ya kpamkpam ruo mgbe agbazere stool niile.

(3) Swabs sample: tinye kwụ ọtọ 500ul sample mmịpụta ngwọta (ihe dị ka 15 tụlee) n'ime tube mmịpụta sample. Fanye swab anakọtara n'ime ihe ngwọta na tube ntinye ihe nlele, ma tụgharịa ya nso na mgbidi dị n'ime nke tube ule ihe dị ka ugboro 10 iji mee ka nlele ahụ gbazee na ngwọta dị ka o kwere mee. Ghichaa isi swab nke swab n'akụkụ mgbidi dị n'ime nke eriri mmịpụta iji mee ka mmiri dị na tube dị ka o kwere mee, wepụ ma tụfuo swab. Kpuchie mkpuchi.

2. Usoro nchọpụta:

( 1) Mgbe kaadị ule laghachiri n'ime ụlọ, mepee akpa foil aluminum wee wepụ kaadị ule ahụ ma tinye ya n'ahịrị na desktọpụ.

(2) Tinye 65ul (ihe dị ka 2 tụlee) nke ihe nlele nke edoziri ma ọ bụ tinye 65ul ozugbo (ihe dị ka 2 tụlee) nke ngwọta nje a na-edozi na oghere nlele nke kaadị ule.

(3) Gụọ nsonaazụ egosipụtara n'ime nkeji 15-30, na nsonaazụ a gụrụ mgbe nkeji 30 gachara adịghị mma.

【INsụgharịION OF TEST RESULTS】

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【LIMITATION OF ChọpụtaION METHOD】

1. Clinical nkwenye

Iji nyochaa arụmọrụ nchoputa a, ihe omumu a jiri ihe nlere anya nke COVID-19 sitere na mmadụ 252 yana COVID-19-adịghị mma sitere na mmadụ 686. Ejiri usoro RT-PCR nwalere ma kwadokwa ụdị ihe atụ ndị a. Nsonaazụ dị ka ndị a:

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

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

2. Oke nchọpụta kacha nta:

Mgbe ọdịnaya nje karịrị 400TCID50/ml, ọnụọgụ nchọpụta dị mma karịrị 95%. Mgbe ọdịnaya nje na-erughi 200TCID50/ml, ọnụọgụ nchọpụta dị mma bụ ihe na-erughị 95%, yabụ njedebe kacha nta nke ngwaahịa a bụ 400TCID50/ml.

3. nkenke:

A nwalere ogbe atọ na-eso ụzọ nke reagents maka nkenke. A na-eji ogbe dị iche iche nke reagents nwalee otu ihe na-adịghị mma ugboro 10 n'usoro, na nsonaazụ ya niile adịghị mma. A na-eji ogbe dị iche iche nke reagents nwalee otu ezigbo nlele ugboro iri n'usoro, na nsonaazụ ya niile dị mma.

4. Mkpịsị aka:

Mgbe ọdịnaya nje dị na nlele a ga-anwale ruru 4.0*105TCID50/ml, nsonaazụ nnwale ahụ egosighi mmetụta HOOK.

5. Cross-reactivity

A tụlere mmegharị mmegharị nke ngwa ahụ. Nsonaazụ egosighi mmeghari mmegharị site na nlere ndị a.

6. Ihe ntinye aka

A naghị egbochi nsonaazụ ule ahụ na ihe ahụ na ntinye uche ndị a:

【LIMITATION OF ChọpụtaION METHOD】

1. A na-enye ngwaahịa a naanị ụlọ nyocha ụlọ ọgwụ ma ọ bụ ndị ọrụ ahụike maka nnwale ozugbo, enweghị ike iji ya mee nnwale ụlọ.

2. Ngwaahịa a dị mma naanị maka nchọpụta nke oghere imi mmadụ ma ọ bụ ihe omimi nke akpịrị. Ọ na-achọpụta ihe nje virus dị n'ime ihe nlele,

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