SARS-CoV-2 Antigen Rapid Test Cassette

Ezubere iji

NkeSARS-CoV-2 Antigen Rapid Test Cassettebụ ngwa ngwa chromatographic immunoassay maka nchọpụta qualitative nke SARS-CoV-2 antigen na Oropharyngeal swabs mmadụ. Nchọpụta ahụ dabeere na ọgwụ mgbochi monoclonal kpọmkwem maka Nucleocapsid (N) Protein nke SARS-CoV-2. Ezubere ya iji nyere aka na ngwa ngwa dị iche iche nchoputa nkeCOVID 19ọrịa.

Nkọwa ngwugwu

25 ule/mkpọ, 50 ule/mkpọ, 100 ule/mkpọ

Okwu mmalite

Akwụkwọ akụkọ coronaviruses bụ nke β genus.COVID 19bụ nnukwu ọrịa na-efe efe na-efe efe na-efe efe. Ndị mmadụ na-enwekarị ngwa ngwa. Ugbu a, ndị ọrịa bu ọrịa coronavirus novel bụ isi ihe na-ebute ọrịa; ndị butere ọrịa asymptomatic nwekwara ike bụrụ ihe na-efe efe. Dabere na nyocha ọrịa na-efe efe ugbu a, oge nnabata bụ 1. ruo ụbọchị 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.

Ndị na-eme mgbanwe

Kaseti ule ahụ nwere ihe mgbochi SARS-CoV-2 Nucleocapsid protein particles na mgbochi SARS-CoV-2 protein Nucleocapsid mkpuchi na akpụkpọ ahụ.

MKPACHAPỤ ANYA

Biko gụọ ozi niile dị na ntinye ngwugwu a tupu ịme ule ahụ.

1.N'ihi ọkachamara in vitro diagnostic were naanị. Ejila ụbọchị ngafe gachara.

2.The ule kwesịrị ịnọgide na-akpachichi akpa ruo mgbe njikere iji.

3. A ga-ewere ụdịdị niile dị ka ihe dị ize ndụ ma mee ya n'otu ụzọ ahụ dịka onye na-ahụ maka ọrịa.

4.A ga-atụfu ule eji eme ihe dịka iwu obodo si dị.

5.Zere iji ihe nlele ọbara.

6.Wear gloves wen inye ihe atụ, zere imetụ akpụkpọ ahụ reagent na sample nke ọma.

Nchekwa na Nkwụsi ike

Oge nkwado bụ ọnwa 18 ma ọ bụrụ na echekwara ngwaahịa a na gburugburu

2-30℃.The ule bụ kwụsiri ike site ngafe ụbọchị e biri ebi na akara pouch.The ule ga-anọgide na anọkwasị obere akpa ruo mgbe ojiji..EKWESỊGHỊ KWESỊRỊ.Ejila ụbọchị ngafe gafere.

Mkpokọta na Nkwadebe ihe atụ

1.Mkpokọta secretion 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 dị n'azụ.

ike, zere imetụ ire ma wepụ swab.

2.Process ihe nlele ozugbo na ihe ngwọta mmịpụta nke a na-enye na kit mgbe a na-anakọta 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 ℃.

3. 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.

Ngwa ngwa

Ihe na-enye

Ihe achọrọ mana anaghị enye ya

Nkọwa25

ule/mkpọ50

ule/mkpọ100

ule/mkpọSample mmịpụta Reagent25 ule/ngwugwu 50/ngwugwu 100 ule/mkpọSample mmịpụta

tube≥25 ule/mkpọ≥50 ule/mkpọ≥100 ule/ngwugwu Ntuziaka na-ezo aka na

ngwugwu zoro aka na

ngwugwu zoro aka na

ngwugwu

Ntuziaka maka ojiji

Kwe ka ule ahụ, ihe nlere anya, ihe nchekwa mmịpụta ka ọ dabara na ọnụ ụlọ (15-30 ℃) tupu nnwale.

1.Wepu cassette ule na obere akpa foil mechiri emechi ma jiri ya n'ime nkeji iri na ise. A ga-enweta nsonaazụ kacha mma ma ọ bụrụ na a na-eme nyocha ahụ ozugbo meghere obere akpa foil.

2.Place na Extraction Tube na-arụ ọrụ station.Hold mmịpụta reagent kalama kpodoro isi ala.Apịnye karama ahụ ka ihe niile nke ngwọta (Approx,250μL) ịdaba n'ime mmịpụta tube kpamkpam na-enweghị imetụ ọnụ nke tube na mmịpụta. Tube.

3. Tinye ihe nlele swab na tube Extraction. Gbanwee swab maka ihe dịka 10 sekọnd mgbe ị na-agbanye isi n'ime tube iji hapụ antigen na swab.

4.Wepụ swab mgbe ị na-amanye isi swab megide n'ime tube Extraction ka ị na-ewepụ ya iji chụpụ mmiri mmiri dị ka o kwere mee na-emepụta swab.Tụfuo swab dị ka usoro ikpofu ihe mkpofu biohazard si dị.

5.Fit na dropper n'ọnụ n'elu nke mmịpụta tube. Debe kaseti ule na elu dị ọcha na larịị.

6.Tinye 2 tụlee nke ngwọta (ihe dị ka, 65μL) na nlele ahụ nke ọma wee malite ngụ oge. Gụọ ihe egosipụtara n'ime 20-30 nkeji, na nsonaazụ ndị a gụrụ mgbe 30 nkeji abaghị uru.

NKWU OKWU KWESỊRỊ

Otu ahịrị nwere agba na-egosi na mpaghara akara akara (C). Ọ dịghị ahịrị na-apụta na mpaghara ule (T) .Nsonaazụ na-adịghị mma na-egosi na SARS-CoV-2 antigen adịghị na ụdị, ma ọ bụ dị n'okpuru ọkwa a na-achọpụta nke ule ahụ.

EZIOKWUNsonaazụ:

Ahịrị abụọ pụtara.otu ahịrị agba kwesịrị ịdị na mpaghara njikwa (C) na ahịrị agba ọzọ pụtara ìhè kwesịrị ịdị na mpaghara nnwale (T) nsonaazụ dị mma na-egosi na achọpụtara SARS-CoV-2 n'ụdị.

Nsonaazụ ezighi ezi:

Ahịrị njikwa adaghị apụta. Oke nlere ezughi oke ma ọ bụ usoro usoro na-ezighi ezi bụ ihe kpatara ọdịda akara njikwa. Nyochaa usoro ahụ wee jiri ule ọhụrụ megharịa ule ahụ. Ọ bụrụ na nsogbu ahụ dịgidere, kwụsị iji ngwa nnwale ozugbo wee kpọtụrụ onye nkesa mpaghara gị.

IHE:

Ike nke agba na mpaghara ahịrị nnwale (T) ga-adịgasị iche dabere na mkpokọta SARS-CoV-2 Antigen dị na ụdị. Ya mere, ndò ọ bụla nke agba na mpaghara akara ule (T) kwesịrị ka a na-ewere dị mma.

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 wicking akpụkpọ ahụ zuru oke.
• Ejikwaghị ụkpụrụ njikwa na ngwa a; 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.

OKWUNKE Nnwale

1. The SARS-CoV-2 Antigen Rapid Test Cassette bụ maka ọkachamara in vitro diagnostic ojiji naanị.Ekwesịrị iji ule ahụ maka nchọpụta SARS-CoV-2 Antigen na Oropharyngeal Swab.Ọ bụghị ọnụọgụ ọnụọgụ ma ọ bụ ọnụego mmụba na SARS- Enwere ike ikpebi itinye uche CoV-2 site na nnwale qualitative a.
2. Izi ezi nke ule na-adabere n'ịdị mma nke swab sample. Ihe ọjọọ ndị na-adịghị mma nwere ike ime ka ọ bụrụ nchekwa nchekwa mkpokọta na-ezighị ezi.
3. SARS-CoV-2 Antigen Rapid Test Cassette ga-egosi naanị ọnụnọ SARS-CoV-2 na ụdị sitere na ụdị coronavirus SARS-CoV-2 nke nwere ike ma ọ bụ nke na-enweghị ike.
4. Dị ka ọ dị n'ule nyocha niile, a ga-atụgharịrịrị nsonaazụ niile yana ozi ụlọ ọgwụ ndị ọzọ dị dọkịta nwere.
5. PCR ga-ekwenye na nsonaazụ na-adịghị mma enwetara na ngwa a. Enwere ike nweta nsonaazụ na-adịghị mma ma ọ bụrụ na mkpokọta SARS-CoV-2 dị na swab ezughị oke ma ọ bụ n'okpuru ọkwa nnwale ahụ.
6. Ọbara ma ọ bụ imi dị n'ụdị swab nwere ike igbochi arụmọrụ ma nwee ike iwepụta nsonaazụ dị mma.
7. Nsonaazụ dị mma maka SARS-CoV-2 anaghị egbochi ọrịa nje na-efe efe nke ọzọ. Ya mere, a ga-atụle ohere nke ọrịa nje na-adịghị ahụkebe.
8. Nsonaazụ na-adịghị mma anaghị ewepụ ọrịa SARS-CoV-2, ọkachasị ndị butere nje ahụ. Ekwesịrị ịtụle nyocha nleba anya na nyocha nke mkpụrụ ndụ iji kpochapụ ọrịa na ndị a.
9. Nsonaazụ dị mma nwere ike ịbụ n'ihi ọrịa ugbu a nwere ụdị coronavirus na-abụghị SARS-CoV-2, dị ka coronavirus HKU1, NL63, OC43, ma ọ bụ 229E.
10. E kwesịghị iji nsonaazụ sitere na nnwale antigen dị ka naanị ihe ndabere iji chọpụta ma ọ bụ wepu ọrịa SARS-CoV-2 ma ọ bụ gwa ọkwa ọrịa.
11. Extraction reagent nwere ikike igbu nje , ma ọ nweghị ike ime ka 100% nke nje ahụ rụọ ọrụ. Usoro nke inactivating nje nwere ike na-ezo aka: kedu usoro nke WHO / CDC na-atụ aro, ma ọ bụ enwere ike ijikwa ya dịka iwu obodo si dị.

ÀJỤMỤ ỌRỤ

MmetụtanaNkọwapụta

A na-enyocha kasetị nke SARS-CoV-2 Antigen Rapid Test Cassette site na ụdị nke enwetara n'aka ndị ọrịa. A na-eji PCR dị ka usoro ntụaka maka SARS-CoV-2 Antigen Rapid Test Cassette. A na-ahụta ụdị ihe dị mma ma ọ bụrụ na PCR gosipụtara nsonaazụ dị mma.

Mmetụta mmetụta:95.0%(95%CI*:83.1%-99.4%)

Nkọwapụta:99.2%(95%CI*:97.6%-99.8%)

* Oge ntụkwasị obi

Oke nchọpụta

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

Nkenkenke

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.

Mmetụta HOOK

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

Cross-Reactivity

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

IIhe na-akpaghasị ihe

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

IBIBLIOGRAPHY

1.Weiss SR,Leibowitz JZ.Coronavirus pathogenesis. Nje Virus Adv 2011;81:85-164
2.Cui J, Li F, Shi ZL. Mmalite na evolushọn nke ọrịa coronaviruses.Nat Rev Microbiol 2019;17:181-192.
3.Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. TrendsMicrobiol 2016;24:490-502.