Ngwa nyocha ngwa ngwa COVID-19 IgG/IgM

Nkọwa ngwa ngwa

Ngwa nyocha ngwa ngwa COVID-19 IgG/IgM AMRDT100 (Ọbara dum/Serum)

Nkwakọ ngwaahịa & nnyefe

Nkọwapụta

[Eburu n'uche iji]
AMRDT100 IgG/IgM Rapid Test Cassette bụ mpụta chromatographic immunoassay maka nchọpụta qualitative nke ọgwụ mgbochi ọrịa (IgG na IgM) na Novel coronavirus n'ime ọbara mmadụ / serum / Plasma dum.
Ọ na-enye aka na nchoputa nke ọrịa na Novel coronavirus.

[NKWUO]
Na mbido Jenụwarị 2020, achọpụtara coronavirus ọhụrụ (SARS-CoV-2, nke a na-akpọbu 2019-nCoV) dị ka onye na-efe efe na-ebute ntiwapụ nke oyi baa na Wuhan, China, ebe ikpe mbụ nwere akara ngosi ha malitere na Disemba 2019.
Coronaviruses bụ nje RNA kpuchiri ekpuchi nke na-ekesa n'etiti ụmụ mmadụ, anụmanụ ndị ọzọ na nnụnụ na nke na-ebute ọrịa iku ume, enteric, hepatic, na neurologic.Nje virus anọ-229E, OC43, NL63, na HKU1 juru ebe niile ma na-ebutekarị mgbaàmà oyi n'ahụ ndị mmadụ na-enweghị ike.Udiri abụọ ndị ọzọ siri ike coronavirus (SARS-CoV) na Middle East akụkụ okuku ume na ọrịa coronavirus (MERS-CoV) sitere na zoonotic na ejirila ya na ọrịa na-egbu egbu mgbe ụfọdụ.
Coronaviruses bụ zoonotic, nke pụtara na a na-ebufe ya n'etiti anụmanụ na mmadụ.Ihe mgbaàmà a na-ahụkarị nke ọrịa na-agụnye mgbaàmà iku ume, ahụ ọkụ, ụkwara, mkpụmkpụ ume na iku ume.N'ọnọdụ ndị ka njọ, ọrịa nwere ike ịkpata oyi baa, nnukwu ọrịa iku ume, ọdịda akụrụ na ọbụna ọnwụ.
Ndụmọdụ dị mma iji gbochie mgbasa ọrịa gụnyere ịsacha aka mgbe niile, ikpuchi ọnụ na imi mgbe ị na-asụ ụkwara na imi, sie anụ na akwa nke ọma.Zenarị mmekọrịta chiri anya gị na onye ọ bụla na-egosi mgbaàmà nke ọrịa iku ume dị ka ụkwara na ọzịza.

[IWU]
AMRDT100IgG/IgM Ngwa ngwa ule Cassette bụ qualitative membrane strip based immunoassay maka nchọpụta ọgwụ mgbochi ọrịa (IgG na IgM) na Novel coronavirus n'ime ọbara mmadụ / Serum / Plasma dum.Kaseti ule ahụ nwere: 1) pad conjugate na-acha agba burgundy nwere Novel coronavirus recombinant envelopu antigens conjugated na Colloid gold (Novel coronavirus conjugates), 2) nitrocellulose akpụkpọ ahụ nke nwere ahịrị ule abụọ (IgG na IgM ahịrị) na akara njikwa. C ahịrị).Ekpuchiri ahịrị IgM ahụ na mgbochi Mouse anti-Human IgM, akara IgG na-egbochi mgbochi mmadụ IgG.Mgbe a na-ekesa oke nlere ule zuru oke n'ime olulu mmiri nlele nke cassette, ihe nlere ahụ na-akwaga site na capillary edinam gafee cassette.IgM mgbochi novel coronavirus, ọ bụrụ na ọ dị na ụdị, ga-ejikọta na njikọ nke Novel coronavirus.A na-ejide immunocomplex ahụ site na reagent kpuchiri ya na band IgM, na-eme ahịrị IgM nwere agba burgundy, na-egosi nsonaazụ nyocha IgM Novel coronavirus.IgG mgbochi-Novel coronavirus ma ọ bụrụ na ọ dị na ihe nlere ahụ ga-ejikọta na njikọ nke Novel coronavirus.A na-ejide immunocomplex ahụ site na reagent mkpuchi mkpuchi na ahịrị IgG, na-eme ahịrị IgG nwere agba burgundy, na-egosi nsonaazụ nyocha nke Novel coronavirus IgG.Enweghị ahịrị T ọ bụla (IgG na IgM) na-egosi nsonaazụ adịghị mma.Iji jee ozi dị ka njikwa usoro, eriri nwere agba ga-apụta mgbe niile na mpaghara ahịrị akara na-egosi na agbakwunyere olu kwesịrị ekwesị nke ihe nlere na akpụkpọ anụ ahụ emeela.

[Ịdọ aka ná ntị na ịkpachara anya]
Maka ndị ọkachamara ahụike na ndị ọkachamara na ebe nlekọta.
Ejila mgbe ụbọchị njedebe gachara.
Biko gụọ ozi niile dị na mpempe akwụkwọ a tupu ịme ule ahụ.
Kaseti ule kwesịrị ịdị na obere akpa ahụ emechiri emechi ruo mgbe ejiri ya.
Ekwesịrị ịtụle ụdịdị niile dị ka ihe dị ize ndụ ma mee ya n'otu ụzọ ahụ dịka onye na-efe efe na-efe efe.
Ekwesịrị ịtụfu kaseti ule ejiri mee ihe dịka iwu gọọmentị etiti, steeti na mpaghara siri dị.

[MGBE]
Nnwale ahụ nwere mpempe akpụkpọ anụ nke ejiri Mouse anti-Human IgM antibody na Mouse anti-Human IgG mgbochi n'ahịrị ule, yana akwa akwa nke nwere ọla edo colloidal yana Novel coronavirus recombinant antigen.
Ebipụtara ọnụọgụ ule na labeling.
Ihe Enyere
Nwalee ntinye kasetiPackage
Ihe nchekwa
Ihe achọrọ mana enyeghị ya
Akpa nchịkọta ihe atụ TimeTimer

[Nchekwa na Nkwụsi ike]
Chekwaa dị ka akpachịkọtara n'ime obere akpa akara na okpomọkụ (4-30 ℃ ma ọ bụ 40-86 ℉).Ngwa ahụ kwụsiri ike n'ime ụbọchị njedebe nke ebipụtara na labeling.
Ozugbo meghere obere akpa ahụ, a ga-eji ule ahụ mee ihe n'ime otu awa.Ikpughe ogologo oge na gburugburu ebe dị ọkụ na iru mmiri ga-ebute mmebi ngwaahịa.
Ebipụtara LOT na ụbọchị njedebe na labeling.

[SPECIMAN]
Enwere ike iji ule a nwale nleba anya zuru oke nke ọbara/Serum/Plasma.
Iji nakọta ọbara zuru oke, serum ma ọ bụ plasma na-eso usoro ụlọ nyocha ụlọ ọgwụ mgbe niile.
Kewapụ serum ma ọ bụ plasma na ọbara ozugbo enwere ike iji zere hemolysis.Jiri naanị ihe nlere anya na-abụghị hemolyzed doro anya.
Chekwaa ihe nlele na 2-8℃ (36-46℉) ma ọ bụrụ na anwaleghị ya ozugbo.Na-echekwa ihe nlele na 2-8 ℃ ruo ụbọchị 7.Ekwesịrị ka oyi kpọnwụrụ ụdịdị ahụ na
-20℃ (-4℉) maka nchekwa ogologo.Akwụsịla ụdị ọbara dum.
Zenarị usoro ntu oyi na-agbaze ọtụtụ ugboro.Tupu anwale, weta ụdị oyi kpọnwụrụ n'ime ụlọ ahụ nwayọ wee gwakọta nwayọ.A ga-akọwapụta ihe nlere nwere obere ihe a na-ahụ anya site na centrifugation tupu nnwale.
Ejila ihe nlele na-egosi oke lipemia, nnukwu hemolysis ma ọ bụ turbidity iji zere ndabichi na nkọwa nsonaazụ.

[Usoro ule]
Kwe ka ngwaọrụ ule na ụdị nha nhata na okpomọkụ (15-30℃ ma ọ bụ 59-86℉) tupu nnwale.
1.Wepu cassette ule na obere akpa akara.
2.Jide dropper ahụ kwụ ọtọ ma nyefee 1 dobe nke ihe atụ na ihe nlele nke ọma (S) nke ngwaọrụ ule, wee tinye 2 tụlee nke ihe nchekwa (ihe dị ka 70μl) wee malite ngụ oge.Lee ihe atụ a n'okpuru.
3.Chere ka ahịrị agba pụta.Tụgharịa asụsụ nsonaazụ ule n'ime nkeji iri na ise.Agụla nsonaazụ mgbe nkeji iri abụọ gachara.

[Nkọwa nke nsonaazụ]
Ezi: Ahịrị njikwa na opekata mpe otu ahịrị ule na-apụta na akpụkpọ ahụ.Ọdịdị nke ahịrị ule IgG na-egosi ọnụnọ nke Novel coronavirus kpọmkwem ọgwụ mgbochi IgG.Ọdịdị nke ahịrị ule IgM na-egosi ọnụnọ nke Novel coronavirus kpọmkwem ọgwụ mgbochi IgM.Ma ọ bụrụ na ahịrị IgG na IgM pụtara, ọ na-egosi na ọnụnọ nke ma Novel coronavirus kpọmkwem IgG na IgM ọgwụ mgbochi.
Na-adịghị mma: Otu ahịrị na-acha na-egosi na mpaghara njikwa (C) .Ọ dịghị ahịrị agba pụtara na mpaghara akara ule.
Na adịghị mma: Ahịrị njikwa agaghị apụta.Oke ihe atụ ezughi oke ma ọ bụ usoro usoro na-ezighi ezi bụ ihe kachasị kpatara ọdịda akara njikwa.Nyochaa usoro ahụ wee jiri cassette ule ọhụrụ megharịa ule ahụ.Ọ bụrụ na nsogbu ahụ dịgidere, kwụsị iji ngwa nnwale ozugbo wee kpọtụrụ onye nkesa mpaghara gị.

[Ọdịmma njikwa]
Agụnyere njikwa usoro n'ule ahụ.A na-ewere ahịrị nwere agba na-apụta na mpaghara njikwa (C) dị ka njikwa usoro n'ime.Ọ na-akwado oke ihe atụ zuru oke, nhịahụ akpụkpọ ahụ zuru oke yana usoro usoro ziri ezi.
Ejighị ngwa njikwa eweta ụkpụrụ njikwa.Otú ọ dị, a na-atụ aro ka a nwalee njikwa dị mma na nke na-adịghị mma dị ka ezigbo ụlọ nyocha iji kwado usoro ule na iji nyochaa arụmọrụ ule kwesịrị ekwesị.

[LIMITATIONS]
AMRDT100 IgG/IgM Kasịtị Nnwale ngwa ngwa nwere oke iji nye nchọta qualitative.Ịdị ike nke ahịrị ule anaghị ejikọta na ntinye nke mgbochi n'ime ọbara.
Ihe nchoputa enwetara na ule a bu n'obi ka ọ bụrụ enyemaka na nyocha naanị.Dọkịta ọ bụla ga-akọwarịrị nsonaazụ ya na akụkọ ihe mere eme nke onye ọrịa, nchọpụta anụ ahụ, na usoro nyocha ndị ọzọ.
Nsonaazụ ule na-adịghị mma na-egosi na ọgwụ mgbochi ọrịa Novel coronavirus anọghị ma ọ bụ na ọkwa a na-achọpụtaghị site na nnwale ahụ.

[Ụkpụrụ omume]
izi ezi
Emere ntụnyere n'akụkụ n'akụkụ site na iji Nyocha ngwa ngwa coronavirus IgG/IgM na PCR azụmahịa na-eduga.A tụlere ụdị nyocha ụlọ ọgwụ 120 sitere na saịtị nlekọta ọkachamara.Edepụtara nsonaazụ ndị a site na ọmụmụ ụlọ ọgwụ ndị a:
E mere ntụnyere ọnụ ọgụgụ n'etiti nsonaazụ na-enye mmetụta nke 90.00%, nkọwapụta nke 97.78% yana izi ezi nke 95.83%.
Cross-reactivity na nnyonye anya
1.A na-enyocha ihe ndị ọzọ na-akpatakarị ọrịa na-efe efe maka cross reactivity na ule.Ụfọdụ ezigbo ụdị ọrịa ndị ọzọ na-efe efe ka agbasara n'ime akwụkwọ akụkọ novel coronavirus dị mma na nke na-adịghị mma wee nwalee iche.A hụghị mmeghachi omume nke cross site na ụdị ndị ọrịa bu nje HIV, HAV, HBsAg, HCV, HTLV, CMV, FLUA, FLUB, RSV na TP.
2.Potentially cross-reactive endogenous bekee gụnyere nkịtị serum components, dị ka lipids, hemoglobin, bilirubin, bụ spiked na elu mkpokọta n'ime novel coronavirus mma na-adịghị mma ụdị na nwalere, iche iche.Enweghị mmegharị mmegharị ma ọ bụ nnyonye anya ahụrụ na ngwaọrụ ahụ.
3. Ụfọdụ ndị ọzọ na-enyocha ihe ndị dị ndụ ka agbanyere n'ime akwụkwọ akụkọ coronavirus dị mma na nke na-adịghị mma wee nwalee iche iche.Enweghị nnyonye anya dị ịrịba ama na ọkwa ndị edepụtara na tebụl dị n'okpuru.

Mmụgharị
Emere ọmụmụ mmụgharị maka Novel coronavirus IgG/IgM Rapid Test na ụlọ nyocha ụlọ ọrụ dibịa atọ (POL).Iri isii (60) ihe nlele serum ụlọ ọgwụ, 20 adịghị mma, 20 dị mma na oke 20, ka ejiri mee ihe n'ọmụmụ ihe a.A na-agba ọsọ nke ọ bụla n'ime ugboro atọ maka ụbọchị atọ na POL ọ bụla.Nkwekọrịta intra-assay bụ 100%.Nkwekọrịta n'etiti saịtị bụ 100 %.

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