COVID-19 Antigen Yihuta Yipimisha Cassette (Zahabu ya Colloidal) Ishusho Yerekanwe

COVID-19 Antigen Yihuta Ikizamini Cassette (Zahabu ya Colloidal)

Ibisobanuro bigufi:

Ibicuruzwa birambuye

Ibicuruzwa

UKORESHEJWE

COVID-19 Antigen Rapid Test Cassette (Zahabu ya Colloidal) ni immunoassay itembera igamije gutahura ubuziranenge bwa SARS-CoV-2 nucleocap- sid antigene mu mazuru yabantu bakekwaho kuba COVID-19 nabashinzwe ubuzima.

Ibisubizo ni ukumenya SARS-CoV-2 nucleocapsid antigen.Antigen isanzwe igaragara mumazuru mugihe cyicyiciro cyanduye.Ibisubizo byiza byerekana ko hariho antigene za virusi, ariko ihuriro ry’amavuriro n'amateka y'abarwayi hamwe n'andi makuru yo gusuzuma ni ngombwa kugira ngo umenye aho wanduye.Ibisubizo byiza ntibibuza kwandura bagiteri cyangwa kwandura izindi virusi.Umukozi wamenyekanye ntashobora kuba intandaro yindwara.

Ibisubizo bibi ntibibuza kwandura SARS-CoV-2 kandi ntibigomba gukoreshwa nk'ishingiro ryonyine ryo kuvura cyangwa gufata ibyemezo byo gucunga abarwayi, harimo ibyemezo byo kurwanya ubwandu.Ibisubizo bibi bigomba gusuzumwa murwego rwumurwayi aherutse kugaragara, amateka ndetse no kuba hari ibimenyetso byamavuriro nibimenyetso bihuye na COVID-19, kandi bikemezwa na molekile, nibiba ngombwa mugucunga abarwayi.Iki gikoresho kigenewe gukoreshwa nabalayiki ahantu hatari laboratoire (nk'urugo rw'umuntu cyangwa ahantu runaka hatari gakondo nk'ibiro, ibirori by'imikino, amashuri n'ibindi).Ibisubizo by'ibizamini by'iki gikoresho ni ibyavuzwe gusa.Birasabwa gukora isesengura ryimbitse ryimiterere hashingiwe ku barwayi bagaragaye ku mavuriro no mu bindi bizamini bya laboratoire.

INCAMAKE

Igitabo coronavirus (SARS-CoV-2) ni icya gen.COVID-19 ni indwara yandurira mu myanya y'ubuhumekero.Abantu muri rusange birashoboka.Kugeza ubu, abarwayi banduye igitabo cyitwa coronavirus ni isoko nyamukuru yo kwandura;abantu banduye badafite ibimenyetso na bo barashobora kuba isoko yanduye.Ukurikije iperereza ryakozwe muri iki gihe, igihe cyo gukuramo ni iminsi 1 kugeza 14, ahanini iminsi 3 kugeza 7.Ibyigaragaza nyamukuru birimo umuriro, umunaniro hamwe no gukorora byumye.Umubyimba wizuru, izuru ritemba, kubabara mu muhogo, myalgia na diarrhea usanga mubihe bike.

IHame

COVID-19 Antigen Rapid Ikizamini Cassette (Nasal Swab) ni immunoassay itembera kuruhande rushingiye kumahame ya tekinike ya antibody ya sandwich.SARS-CoV-2 nucleocapsid protein monoclonal antibody ihujwe na microparticles yamabara ikoreshwa nka detector hanyuma igaterwa kuri padi ya conjugation.Mugihe cyipimisha, antigen ya SARS-CoV-2 murugero ikorana na antibody ya SARS-CoV-2 ihujwe na microparticles yamabara ikora antigen-antibody yanditseho complexe.Uru ruganda rwimukira muri membrane binyuze mumikorere ya capillary kugeza umurongo wikizamini, aho uzafatwa na SARS-CoV-2 nucleocapsid proteine monoclonal antibody.Umurongo wikizamini cyamabara (T) wagaragara mumadirishya y'ibisubizo niba antigene ya SARS-CoV-2 ihari murugero.Kubura umurongo wa T byerekana ibisubizo bibi.Igenzura ry'umurongo (C) rikoreshwa mugucunga inzira, kandi rigomba guhora rigaragara niba inzira yikizamini ikozwe neza.

UMUBURO N'UBWITONDERWA

• Kwipimisha wenyine muri vitro kwisuzumisha ukoreshe gusa.Iyi cassette ya tset ni iyo gukoreshwa rimwe kandi ntishobora gukoreshwa cyangwa gukoreshwa nabantu benshi.

• Ntukoreshe iki gicuruzwa nkishingiro ryonyine ryo gusuzuma cyangwa gukuraho indwara ya SARS-CoV-2 cyangwa kumenyesha ubwandu bwa COVID-19.

• Nyamuneka soma amakuru yose muri iki gitabo mbere yo gukora ikizamini.

• Ntukoreshe iki gicuruzwa nyuma yitariki yo kurangiriraho.

• Cassette yikizamini igomba kuguma mu gikapu gifunze kugeza ikoreshejwe.

• Ingero zose zigomba gufatwa nkaho zishobora guteza akaga kandi zigakorwa muburyo bumwe nuwanduye.

• Ikizamini cyabana nurubyiruko kigomba gukoreshwa numuntu mukuru.

• Cassette ikoreshwa yikizamini igomba gutabwa hakurikijwe amategeko ya leta, leta ndetse n’ibanze.

• Ntukoreshe ikizamini kubana bari munsi yimyaka 2.

• Abana bato bagomba guhindurwa babifashijwemo numuntu mukuru wa kabiri.

• Karaba intoki neza mbere na nyuma yo gukora.

UMURYANGO

Ibikoresho byatanzwe

• Cassettes Yipimisha: buri cassette hamwe na desiccant mumufuka wa file

• Ibikoresho byo gukuramo byateguwe mbere:

• Sterilized Swabs: imwe ikoresha sterile swab yo gukusanya ingero

• Shyiramo paki

Ibikoresho Birasabwa ariko ntibitangwa

• Igihe

Ububiko N'UBUHAMYA

• Bika nkuko bipakiye mu mufuka ufunze ku bushyuhe (4-30 ℃ cyangwa 40-86 ℉).Igikoresho gihamye mugihe cyigihe cyo kurangiriraho cyanditse kuri label.

• Umaze gufungura umufuka, ikizamini kigomba gukoreshwa mugihe cyisaha imwe.Kumara igihe kinini ibidukikije bishyushye nubushuhe bizatera ibicuruzwa kwangirika.

• NTUBUNTU.

UMWIHARIKO

Ibigereranyo byabonetse hakiri kare mugihe ibimenyetso bitangiye bizaba birimo titereri ya virusi nyinshi;ingero zabonetse nyuma yiminsi itanu yibimenyetso zirashobora gutanga ibisubizo bibi mugihe ugereranije na RT-PCR.Ikusanyirizo ridahagije, ikigereranyo kidakwiye hamwe na / cyangwa ubwikorezi bishobora gutanga ibisubizo bitari byo;kubwibyo, amahugurwa mugukusanya ingero arasabwa cyane kubera akamaro k'icyitegererezo kugirango ubone ibisubizo nyabyo by'ibizamini.Ubwoko bwikigereranyo cyemewe cyo kwipimisha nuburyo butaziguye bwizuru ryabonetse muburyo bwo gukusanya nares ebyiri.Tegura umuyoboro ukuramo ukurikije uburyo bwo kugerageza hanyuma ukoreshe sterile swab yatanzwe mugikoresho cyo gukusanya ingero.

Icyegeranyo Cyizuru Cyizuru

1.Kura swab muri paki.

2.Komeza umutwe wumurwayi inyuma ya 70 °.

3.1-2 Mugihe uzunguruka buhoro buhoro, shyiramo swab hafi cm 2,5 (1 cm) mumazuru kugeza igihe ibitero bihurira kuri turbinates.

4.Kora swab inshuro nyinshi kurukuta rwizuru hanyuma usubiremo mumazuru ukoresheje swab imwe.

Kugereranya Ubwikorezi n'Ububiko

Ntugasubize swab kumapaki yumwimerere.Ibyegeranijwe bishya bigomba gutunganywa vuba bishoboka, ariko bitarenze isaha imwe nyuma yo gukusanya icyitegererezo.

UBURYO BWO GUKORA IKIZAMINI

Icyitonderwa:Emera kaseti yikizamini, reagent hamwe ningero zingana nubushyuhe bwicyumba (15-30 ℃ cyangwa 59-86 ℉) mbere yo kwipimisha.

1. Shira umuyoboro wo gukuramo mu kazi.

2.Kuraho kashe ya aluminiyumu kuva hejuru yumuyoboro ukuramo urimo umuyoboro ukuramo urimo buffer.

3.Icyitegererezo bivuga igice 'Icyegeranyo cy'icyitegererezo'.

4. Shyiramo izuru rya swab urugero mumashanyarazi arimo gukuramo reagent.Kuzunguza swab byibuze inshuro 5 mugihe ukanda umutwe hejuru no kuruhande rwumuyoboro.Kureka izuru mu muyoboro wo gukuramo umunota umwe.

5.Kuramo izuru mugihe ukanda impande zumuyoboro kugirango ukure amazi muri swab.Igisubizo cyakuweho kizakoreshwa nkicyitegererezo.6.Gupfundikanya umuyoboro ukuramo hamwe nigitonyanga.

7.Kuraho cassette yikizamini mumufuka ufunze.

8.Reba ikigereranyo cyo gukuramo icyitegererezo, ufashe umuyoboro uhagaze, wohereze ibitonyanga 3 (hafi 100 μL) buhoro buhoro kurugero rwiza (S) rwa cassette yikizamini, hanyuma utangire igihe.

9.Tegereza imirongo y'amabara igaragara.Sobanura ibisubizo by'ibizamini mu minota 15.Ntusome ibisubizo nyuma yiminota 20.

[IMIKORESHEREZE Y’IMIKORESHEREZE]

Imikorere ya Clinical

Kugereranya imikorere yubuvuzi iri hagati ya COVID-19 Antigen Rapid Test Cassette na PC igereranya na PCR, 628 izuru ryakusanyirijwe mu barwayi bakekwaga na COVID-19.Icyegeranyo cya COVID-19 Antigen Rapid Test Cassette (Nasal Swab) nkuko biri hepfo .

COVID-19 antigen		RT-PCR		Igiteranyo
COVID-19 antigen		Ibyiza	Ibibi	Igiteranyo
HEO®	Ibyiza	172	0	172
HEO®	Ibibi	3	453	456
Igiteranyo		175	453	628

PPA = 98.28% (172/175), (95% CI: 95.08% ~ 99,64%) NPA = 100% (453/453), (95% CI: 99.34% ~ 100%)

PPA - Amasezerano meza ku ijana (Sensitivity) NPA - Amasezerano mabi ku ijana (Umwihariko)

Imipaka yo gutahura (Analytical Sensitivity)

Ubushakashatsi bwakoresheje virusi ya SARS-CoV-2 (Isolate USA-WA1 / 2020 NR- 52287), ubushuhe budakorwa kandi bugashyirwa mu mazuru yo mu mazuru.Imipaka yo Kumenya (LoD) ni 1.0 × 10²TCID₅₀/ mL.

Kwambukiranya umusaraba (Umwihariko wo gusesengura)

Imyitwarire yumusaraba yasuzumwe hifashishijwe ibizamini 32 bya mikorobe na virusi bishobora kuba mu cyuho cyizuru.

Nta reaction-reaction yagaragaye hamwe na poroteyine ya MERS-CoV NP ya recombinant mugihe yapimwe kuri 50 pg / mL.

Nta reaction-reaction yagaragaye hamwe na virusi zikurikira mugihe zapimwe kuri 1.0 × 106 PFU / mL: ibicurane A (H1N1), ibicurane A (H1N1pdm09), ibicurane A (H3N2), ibicurane B (Yamagata), ibicurane B (B) Victoria), Adenovirus (ubwoko bwa 1, 2, 3, 5, 7, 55), metapneumovirus ya muntu,

Virusi ya Parainfluenza (ubwoko bwa 1, 2, 3, 4), virusi yubuhumekero, Enterovirus, Rhinovirus, Coronavirus Yumuntu 229E, Umuntu coronavirus OC43, Umuntu coronavirus NL63, Umuntu coronavirus HKU1.

Nta reaction-reaction yagaragaye hamwe na bagiteri zikurikira mugihe zapimwe kuri 1.0 × 107 CFU / mL: Mycoplasma pneumoniae, Chlamy- dia pneumoniae, pneumophila ya Legionella, ibicurane bya Haemophilus, Streptococcus pyogenes (itsinda A), Streptococcus pneumoniae, Candida albicans. Staphylococcus aureus.

Kwivanga

Ibintu bikurikira bishobora kwivanga byasuzumwe hamwe na COVID-19 Antigen Rapid Test Cassette (Nasal Swab) yibitekerezo byavuzwe haruguru kandi wasangaga bitagira ingaruka kumikorere yikizamini.

Kwibanda ku bintu

Mucin 2%

Benzocaine 5 mg / mL Saline izuru 15%

Oxymetazoline 15%

Tobramycin 5 μg / mL Oseltamivir fosifate 10 mg / mL

Arbidol 5 mg / mL

Fluticasone propionate 5%

Triamcinolone 10 mg / mL

Amaraso yose 4%

Menthol 10 mg / mL

Fenilephrine 15%

Mupirocine 10 mg / mL

Zanamivir 5 mg / mL

Ribavirin 5 mg / mL

Dexamethasone 5 mg / mL

Histamine 10 mg / mL dihydrochloride

Ingaruka nini cyane

COVID-19 Antigen Rapid Ikizamini Cassette (Zahabu ya Colloidal) yapimwe kugeza 1.0 × 10⁵TCID50 / mL ya SARS-CoV-2 idakora kandi nta ngaruka nini yo gufata yagaragaye.

Ironderero ry'ikimenyetso