COVID-19 IgG/IgM Kasetị Nnwale Ọsọ

Maka ọkachamara na in vitro diagnostic were naanị.

Ezubere iji

NkeCOVID-19 IgG/IgM Kasetị Nnwale Ọsọbụ immunoassay nke mpụta nke emebere maka ịchọpụta ọgwụ mgbochi IgG na IgM na nje SARS-CoV-2 n'ọbara dum, serum ma ọ bụ plasma sitere na ndị mmadụ na-enyo enyo na ọ bụ ọrịa COVID-19 site n'aka onye na-ahụ maka ahụike ha.

Nnwale ngwa ngwa CO VID-19 IgG/IgM bụ ihe enyemaka na nyocha nke ndị ọrịa nwere ọrịa SARS-CoV-2 a na-enyo enyo yana mgbakwunye ụlọ ọgwụ yana nsonaazụ nyocha ụlọ nyocha ndị ọzọ. A na-atụ aro ka iji dị ka ihe ngosi nnwale mgbakwunye maka ndị a na-enyo enyo na nnwale nucleic acid na-adịghị mma nke coronavirus ọhụrụ ma ọ bụ jiri ya na nnwale nucleic acid n'ọnọdụ ndị a na-enyo enyo. E kwesịghị iji nsonaazụ sitere na testi ng dị ka naanị ihe ndabere iji chọpụta ma ọ bụ wepu ọrịa SARS-CoV-2 ma ọ bụ iji gwa ọkwa ọrịa.

Nsonaazụ na-adịghị mma anaghị ewepụ ọrịa SARS-CoV-2, ọkachasị ndị na-akpakọrịta na ndị butere ọrịa ama ama ma ọ bụ na mpaghara nwere ọrịa na-arụ ọrụ nke ukwuu. Ekwesịrị ịtụle nyocha nleba anya na nyocha nke mkpụrụ ndụ iji kpochapụ ọrịa na ndị a.

Nsonaazụ dị mma nwere ike ịbụ n'ihi ọrịa n'oge gara aga ma ọ bụ ugbu a nwere ụdị coronavirus na-abụghị SARS-CoV-2.

Ezubere iji ule a n'ụlọ nyocha ụlọ ọgwụ ma ọ bụ ndị ọrụ ahụike n'oge nlekọta, ọ bụghị maka iji ụlọ. E kwesịghị iji ule ahụ mee nyocha ọbara enyere.

Nchịkọta

Akwụkwọ akụkọ coronaviruses bụ nke p genus.COVID 19bụ nnukwu ọrịa na-efe efe nke iku ume. Ndị mmadụ na-enwekarị nsogbu. Ugbu a, ndị ọrịa bu ọrịa coronavirus ọhụrụ bụ isi ihe na-ebute ọrịa; asymptomatic gbara ndị mmadụ n'ụba nwekwara ike ịbụ isi iyi na-efe efe. Dabere na nyocha ọrịa ọrịa 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.

Mgbe nje SARS-CoV2 na-emerụ ahụ mmadụ, RNA, mkpụrụ ndụ ihe nketa nke nje, bụ akara izizi enwere ike ịchọpụta. Profaịlụ ibu nje virus nke SARS-CoV-2 yiri nke influenze, nke na-arị elu n'ihe dị ka oge mgbaàmà mmalite, wee malite ibelata. Site na mmepe nke usoro ọrịa ahụ mgbe ọrịa ahụ gasịrị, usoro ahụ ji alụso ọrịa ọgụ ga-emepụta ọgwụ mgbochi ọrịa, n'ime nke IgM bụ mgbochi mbụ nke ahụ mepụtara mgbe ọrịa ahụ gasịrị, na-egosi nnukwu oge ọrịa. A na-achọpụta ọgwụ mgbochi IgG na SARS-CoV2 ma emechaa bute ọrịa. Nsonaazụ dị mma maka ma IgG na IgM nwere ike ime mgbe ọrịa gasịrị ma nwee ike igosi ọrịa nnukwu ma ọ bụ na nso nso a. IgG na-egosi njedebe nke ọrịa ma ọ bụ akụkọ ihe mere eme nke ọrịa gara aga.

Otú ọ dị, ma IgM na IgG nwere oge windo site na ọrịa nje na mmepụta ihe mgbochi, IgM fọrọ nke nta ka ọ pụta ìhè mgbe ọrịa malitere ọtụtụ ụbọchị, n'ihi ya, nchọpụta ha na-adịkarị n'azụ nchọpụta nucleic acid na ọ dịghị enwe mmetụta karịa nchọpụta nucleic acid. N'ọnọdụ ebe ule mmụba nucleic acid adịghị mma yana enwere njikọ siri ike na-efe efe na ọrịa COVID-19, ụdị serum jikọtara ọnụ (n'oge nnukwu na convalescent) nwere ike ịkwado nchoputa.

Ụkpụrụ

COVID-19 IgG/IgM Kasetị Nnwale Ọsọ(WB/S/P) bụ qualitative membrane strip based immunoassay maka nchọpụta ọgwụ mgbochi ọrịa (IgG na IgM) na Novel coronavirus n'ime ọbara mmadụ / serum / plasma. Kaseti ule nwere:1) pad coiyugate na agba burgundy nwere novel coronavirus recombinant envelopu antigens coi^ugated na Colloid gold (Novel coronavirus c两ugates), 2) eriri akpụkpọ anụ nitrocellulose nwere ahịrị ule abụọ (ahịrị IgG na IgM) yana akara njikwa (akara C). Ejiri ihe mgbochi Mouse anti-Human IgM kpuchie ahịrị IgM ahụ, a na-ekpuchi ahịrị IgG nke Mouse anti-Human IgG antibody, mgbe oke oke nke ka ewepụrụ ntule n'ime olulu mmiri nlele nke cassette. Ihe nlere anya na-akwaga site na capillary omume gafee cassette. IgM mgbochi-Novel coronavirus, ọ bụrụ na ọ dị na ụdị ahụ, ga-ejikọta na akwụkwọ akụkọ coronavirus coiyugates. 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 ọ dị na ihe nlere ahụ ga-ejikọta na njikọ nke Novel coronavirus. A na-ejide immunocomplex ahụ site na reagent kpuchie na lhe IgG ahịrị, na-eme ahịrị IgG nwere agba burgundy, na-egosi nsonaazụ nyocha nke Novel coronavirus IgG. Enweghị ahịrị T ọ bụla (IgG na IgM) na-atụ aro a

nsonaazụ ọjọọ. 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

• N'ihi na in vitro diagnostic ojiji naanị.
• Maka ndị ọkachamara ahụike na ndị ọkachamara ebe nlekọta.

• Ejila mgbe ụbọchị ngafe gachara.

• biko gụọ ozi niile dị na mpempe akwụkwọ a tupu ịme ule ahụ. • Cassette ule kwesịrị ịdị n'ime 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 ndị na-efe efe na-efe efe.

• Ekwesịrị ịtụfu kaseti ule eji eme ihe dịka iwu gọọmentị etiti, steeti na mpaghara siri dị.

MGBE

Nnwale ahụ nwere mpempe akpụkpọ ahụ nke ejiri mgbochi mgbochi mmadụ IgM kpuchie Mouse yana mgbochi mgbochi mmadụ IgG.

ahịrị nnwale, yana mpe mpe akwa nke nwere ọla edo colloidal yana yana Novel corona virus recombinant antigen. Ebipụtara ọnụọgụ ule na labeling.

Ihe Enyere

• Nwale cassette • Ntinye ngwugwu
• Nchekwa • Dropper
• Lancet

Ihe achọrọ mana enyeghị ya

• Akpa nchịkọta ihe atụ • Ngụ oge

Nchekwa na Nkwụsi ike

• Chekwaa dị ka ngwugwu n'ime obere akpa emechiri emechi na okpomọkụ (4-30″ Cor 40-86°F) ngwa ahụ kwụsiri ike n'ime ụbọchị njedebe ebipụtara na labeling.

• Ozugbo emepere obere akpa ahụ, a ga-eji obere 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 n'ụdị akara ngosi

• Enwere ike iji ule a nwale n'ụdị ọbara/Serum/Plasma dum.

• 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 ụdịdị na 2-8 Celsius (36-46T) ma ọ bụrụ na anwaleghị ya ozugbo. Na-echekwa ihe nlele na 2-8 Celsius C ruo ụbọchị 7. Ekwesịrị ka oyi kpọnwụrụ ihe nlele ahụ na -20 Celsius (-4°F) maka nchekwa ogologo. Akwụsịla ụdị ọbara dum,

• Zere ọtụtụ okirikiri oyiri, tupu anwale, weta ụdị oyi kpọnwụrụ n'ime ụlọ okpomọkụ nwayọ ma gwakọta nwayọ.

A ga-akọwapụta ihe nlere nwere obere ihe a na-ahụ anya site na centrifugation tupu nnwale.

• Ejila ihe nlele na-egosi nnukwu lipemia nnukwu hemolysis ma ọ bụ turbidity iji zere nnyonye anya na nkọwapụta nsonaazụ.

Usoro ule

Kwe ka ngwaọrụ nnwale na ihe nlere dakọtara na okpomọkụ (15-30 C ma ọ bụ 59-86 T) tupu nnwale.

1. Wepu kaseti ule na obere akpa ahụ emechiri emechi.
2. Jide dobe ahụ kwụ ọtọ wee bufee 1 dobe (ihe dị ka 10 ul) nke ihe nlere n'ime mpaghara elu nke ihe nlele ahụ nke ọma (S) hụ na enweghị afụ ikuku. Maka izi ezi ka mma, nyefee ihe nlele site na pipette nwere ike ibuga 10 ul nke olu. Lee ihe atụ a n'okpuru.
3. Mgbe ahụ, tinye 2 tụlee (ihe dị ka 70 ul) nke nchekwa ozugbo n'ime ihe atụ nke ọma (S).
4. Malite ngụ oge.
5. ka ahịrị ndị nwere agba pụta. Tụgharịa asụsụ nsonaazụ ule na nkeji iri na ise. Agụla nsonaazụ mgbe nkeji iri abụọ gachara.

Mpaghara maka ụdịdị

(Foto a bụ maka naanị ntụaka, biko rụtụ aka n'ihe ahụ.)

NKWAKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWỤKWASỊA

ọgwụ nje. 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.

adịghị mma:Otu ahịrị agba na-egosi na mpaghara njikwa(C), Ọ nweghị ahịrị na-acha anụnụ anụnụ pụtara na mpaghara ahịrị ule.

Na ezighi ezi:Ahịrị njikwa agaghị apụta. Oke ihe atụ ezughi oke ma ọ bụ usoro usoro na-ezighi ezi bụ ihe kpatara fbr jikwaa ahịrị adaghị. 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.

Njikwa ogo

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.

OKWU

• COVID-19 IgG/IgM Kasetị Nnwale Ọsọ ọsọ (WB/S/P) nwere oke iji nye nka.

nchọpụta. 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 n'ọkwa nke ule ahụ achọpụtaghị.

ÀJỤMỤ ỌRỤ

izi ezi

Nchịkọta data nke CO VID-19 IgG/IgM Ngwa ngwa ngwa dị ka n'okpuru

Banyere ule IgG, anyị agụtala ọnụ ọgụgụ dị mma nke ndị ọrịa 82 n'oge oge nkasi obi.

COVID-19 IgG:

Nsonaazụ na-enye mmetụta uche nke 97.56%

Banyere ule IgM, ntụnyere nsonaazụ ya na RT-PCR.

COVID-19 IgM:

E mere ntụnyere ọnụ ọgụgụ n'etiti nsonaazụ na-enye mmetụta nke 88.61 %, nkọwapụta nke 97.67% na izi ezi nke 93.33%

Cross-reactivity na nnyonye anya

1. A na-enyocha ihe ndị ọzọ na-akpatakarị ọrịa na-efe efe maka cross reactivity na ule. Ụfọdụ nledo dị mma nke ọrịa ndị ọzọ na-efe efe na-agbasa n'ime Novel coronavirus ụdị dị mma na nke na-adịghị mma na d nwalere iche. A hụghị mmeghachi omume nke cross site na ụdị sitere na ndị ọrịa bu nje HIV, HA^ HBsAg, HCV TP, HTIA^ CMV FLUA, FLUB, RSy MP, CP, HPIV.

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 20 ziri ezi, 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 %.