COVID nyinshi-19 Antigen Yihuta Yipimisha Cassette (Zahabu ya Colloidal) abakora nabatanga |HEO

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 (Saliva) ni immunoassay itembera igamije gutahura neza antigene ya SARS-CoV-2 nucleocapsid antivens mumacandwe kubantu bakekwaho kuba COVID-19 nabashinzwe ubuzima.
Ibisubizo ni ukumenya SARS-CoV-2 nucleocapsid antigen.Antigen isanzwe igaragara mumacandwe 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.
COVID-19 Antigen Rapid Test Cassette (Saliva) igenewe gukoreshwa ninzobere mubuvuzi cyangwa abakora imyitozo bahuguwe bafite ubuhanga bwo gukora ibizamini byuruhande.Igicuruzwa gishobora gukoreshwa muri laboratoire iyo ari yo yose kandi itari laboratoire yujuje ibyangombwa bisabwa mu Mabwiriza agenga imikoreshereze n’amabwiriza y’ibanze.
[INCAMAKE]
Igitabo coronavirus (SARS-CoV-2) ni ubwoko bwa p.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.
[INGINGO]
COVID-19 Antigen Rapid Test Cassette (Saliva) ni immunoassay itembera kuruhande rushingiye kumahame ya tekinike ya antibody ya kabiri.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 rwimuka kuri membrane binyuze mubikorwa bya capillary kugeza umurongo wikizamini, aho uzafatwa na SARS-CoV-2 nucleocapsid protein 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]
• Kubikoresha muri vitro kwisuzumisha gusa.
• Kubashinzwe ubuvuzi nabantu ku giti cyabo bahuguwe murwego rwo kwita.
• Ntukoreshe ibicuruzwa nkibishingiro byonyine byo gusuzuma cyangwa gukuramo
Indwara ya SARS-CoV-2 cyangwa kumenyesha uko kwandura COVID-19.
• Ntukoreshe iki gicuruzwa nyuma yitariki yo kurangiriraho.
• Nyamuneka soma amakuru yose muri iki gitabo mbere yo gukora ikizamini.
• Cassette yikizamini igomba kuguma mu gikapu gifunze kugeza ikoreshejwe.
• Ingero zose zigomba gufatwa nkaho zishobora guteza akaga kandi zigakorwa muburyo bumwe nuwanduye.
• Cassette ikoreshwa yikizamini igomba gutabwa hakurikijwe amategeko ya leta, leta ndetse n’ibanze.
[UMURIMO]
Ibikoresho byatanzwe
• Cassettes Yipimisha: buri cassette hamwe na desiccant mumufuka wa file
• Gukuramo Reagents: ampule irimo 0.3 mL yo gukuramo reagent
Abakusanya Amacandwe
• Gukusanya imiyoboro
• Ibitonyanga
• Shyiramo paki
Ibikoresho Birasabwa ariko ntibitangwa
• Igihe
[Ububiko N'UBUHAMYA]
• Bika nkuko bipakiye mu mufuka ufunze ku bushyuhe (4-30 ° C cyangwa 40-86T).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.
• BYINSHI n'itariki yo kurangiriraho byacapishijwe kuri label.
[GUKORANYA BIDASANZWE NO GUTEGURA]
NTUGASHYIZE ikintu cyose mumunwa harimo ibiryo, ibinyobwa, amase cyangwa ibicuruzwa byitabi byibuze byibuze iminota 30 mbere yo gukusanya.
Koresha icyegeranyo cyo gukusanya hamwe nicyegeranyo cyamacandwe kugirango ukusanye amacandwe.Shyiramo icyegeranyo cy'amacandwe mu muyoboro wo gukusanya, hanyuma ushyire icyegeranyo cy'amacandwe hafi y'iminwa hanyuma ureke amacandwe atemba mu muyoboro.Ingano y'amacandwe igomba kuba ku gipimo (hafi 300 | jL).Niba ingano y'amacandwe ari myinshi, koresha igitonyanga kugirango ukureho amacandwe arenze kugeza igisubizo cya nyuma ku gipimo (hafi 300pL).[UKORESHEJWE]
COVID-19 Antigen Rapid Test Cassette (Saliva) ni immunoassay itembera igamije gutahura neza antigene ya SARS-CoV-2 nucleocapsid antivens mumacandwe kubantu bakekwaho kuba COVID-19 nabashinzwe ubuzima.
Ibisubizo ni ukumenya SARS-CoV-2 nucleocapsid antigen.Antigen isanzwe igaragara mumacandwe 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.
COVID-19 Antigen Rapid Test Cassette (Saliva) igenewe gukoreshwa ninzobere mubuvuzi cyangwa abakora imyitozo bahuguwe bafite ubuhanga bwo gukora ibizamini byuruhande.Igicuruzwa gishobora gukoreshwa muri laboratoire iyo ari yo yose kandi itari laboratoire yujuje ibyangombwa bisabwa mu Mabwiriza agenga imikoreshereze n’amabwiriza y’ibanze.
[INCAMAKE]
Igitabo coronavirus (SARS-CoV-2) ni ubwoko bwa p.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.
[INGINGO]
COVID-19 Antigen Rapid Test Cassette (Saliva) ni immunoassay itembera kuruhande rushingiye kumahame ya tekinike ya antibody ya kabiri.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 rwimuka kuri membrane binyuze mubikorwa bya capillary kugeza umurongo wikizamini, aho uzafatwa na SARS-CoV-2 nucleocapsid protein 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]
• Kubikoresha muri vitro kwisuzumisha gusa.
• Kubashinzwe ubuvuzi nabantu ku giti cyabo bahuguwe murwego rwo kwita.
• Ntukoreshe ibicuruzwa nkibishingiro byonyine byo gusuzuma cyangwa gukuramo
Indwara ya SARS-CoV-2 cyangwa kumenyesha uko kwandura COVID-19.
• Ntukoreshe iki gicuruzwa nyuma yitariki yo kurangiriraho.
• Nyamuneka soma amakuru yose muri iki gitabo mbere yo gukora ikizamini.
• Cassette yikizamini igomba kuguma mu gikapu gifunze kugeza ikoreshejwe.
• Ingero zose zigomba gufatwa nkaho zishobora guteza akaga kandi zigakorwa muburyo bumwe nuwanduye.
• Cassette ikoreshwa yikizamini igomba gutabwa hakurikijwe amategeko ya leta, leta ndetse n’ibanze.
[UMURIMO]
Ibikoresho byatanzwe
• Cassettes Yipimisha: buri cassette hamwe na desiccant mumufuka wa file
• Gukuramo Reagents: ampule irimo 0.3 mL yo gukuramo reagent
Abakusanya Amacandwe
• Gukusanya imiyoboro
• Ibitonyanga
• Shyiramo paki
Ibikoresho Birasabwa ariko ntibitangwa
• Igihe
[Ububiko N'UBUHAMYA]
• Bika nkuko bipakiye mu mufuka ufunze ku bushyuhe (4-30 ° C cyangwa 40-86T).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.
• BYINSHI n'itariki yo kurangiriraho byacapishijwe kuri label.
[GUKORANYA BIDASANZWE NO GUTEGURA]
NTUGASHYIZE ikintu cyose mumunwa harimo ibiryo, ibinyobwa, amase cyangwa ibicuruzwa byitabi byibuze byibuze iminota 30 mbere yo gukusanya.
Koresha icyegeranyo cyo gukusanya hamwe nicyegeranyo cyamacandwe kugirango ukusanye amacandwe.Shyiramo icyegeranyo cy'amacandwe mu muyoboro wo gukusanya, hanyuma ushyire icyegeranyo cy'amacandwe hafi y'iminwa hanyuma ureke amacandwe atemba mu muyoboro.Ingano y'amacandwe igomba kuba ku gipimo (hafi 300 | jL).Niba ingano y'amacandwe ari myinshi, koresha igitonyanga kugirango ukureho amacandwe arenze kugeza igisubizo cya nyuma ku gipimo (hafi 300pL).

Kugereranya Ubwikorezi n'Ububiko

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

UBURYO BWO GUKORA IKIZAMINI]

Icyitonderwa: Emerera kaseti yikizamini, reagent hamwe ningero zingana nubushyuhe bwicyumba (15-30 ° C cyangwa 59-86T) mbere yo kwipimisha.

Shira umuyoboro wo gukusanya hamwe n'amacandwe afite amacandwe kuri sitasiyo y'akazi.Kuramo umupfundikizo wa reagent.Ongeramo ibyakuweho byose mubikusanyirizo.

Hagarika umuterankunga w'amacandwe;Gupfundikanya umuyoboro wo gukusanya hamwe nigitonyanga gitonyanga kumuyoboro.Kunyeganyeza umuyoboro wikusanyirizo inshuro zirenze eshatu kugirango uvange amacandwe hamwe nogukuramo reagent, hanyuma ukande igisubizo kivanze inshuro icumi kugirango amacandwe avange neza.

Kuraho cassette yikizamini mumufuka ufunze.

Subiza umuyoboro wo gukusanya, ufashe umuyoboro uhagaze, wohereze ibitonyanga 3 (hafi 100pL) buhoro buhoro kurugero rwiza (S) rwa cassette yikizamini, hanyuma utangire igihe.

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

[GUSOBANURA IBISUBIZO]
Ibyiza \|	§	Imirongo ibiri iragaragara.Umurongo umwe wamabara ugaragara H c mukarere kayobora (C), nundi mabara J.t\| jne igaragara mukarere kizamini (T), utitaye- ubukana bwumurongo wikizamini.
Ibibi		Umurongo umwe wamabara ugaragara mukarere kagenzura (C), kandi nta murongo ugaragara mukarere kizamini (T).
Ntibyemewe		Igenzura ryananiwe kugaragara.Ntabwo bihagije、urugero rwikigereranyo cyangwa tekiniki yuburyo butari bwo 5 niyo mpamvu zishoboka zo kugenzura umurongo kunanirwa.Ongera usuzume inzira na J.tsubiramo ikizamini ukoresheje cassette nshya.NibaJ)ikibazo kirakomeje, hagarika gukoresha ubufindo ako kanya hanyuma ubaze abakwirakwiza hafi.

[KUGENZURA UMUNTU]

Igenzura rikorwa ririmo ikizamini.Umurongo wamabara ugaragara mukarere kayobora (C) ufatwa nkigenzura ryimbere.Yemeza ingano yikigereranyo ihagije, gukuramo membrane ihagije hamwe nubuhanga bukurikirana.

Igipimo cyo kugenzura ntabwo gitangwa niki gikoresho.Ariko, birasabwa ko igenzura ryiza kandi ribi ryageragezwa nkigikorwa cyiza cya laboratoire kugirango hemezwe uburyo bwo gukora ikizamini kandi mubyukuri ikizamini gikwiye.

[LIMITATIONS]

Ibicuruzwa bigarukira gutanga ibisobanuro byujuje ubuziranenge.Ubwinshi bwumurongo wikizamini ntabwo byanze bikunze bifitanye isano nubunini bwa antigen yikigereranyo.
Ibisubizo bibi ntibibuza kwandura SARS-CoV-2 kandi ntibigomba gukoreshwa nkibishingiro byonyine byo gufata ibyemezo byo gucunga abarwayi.
Muganga agomba gusobanura ibisubizo afatanije namateka yumurwayi, ibyagaragaye kumubiri, nubundi buryo bwo gusuzuma.
Ingaruka mbi irashobora kubaho mugihe ubwinshi bwa antigene ya SARS-CoV-2 igaragara murugero iri munsi yurwego rwo gutahura, cyangwa virusi ikaba yarahinduye mutation ntoya ya aside amine mukarere ka epitope yamenyekanye na antibodiyite za monoclonal. ikoreshwa mu kizamini.

[IMIKORESHEREZE Y’IMIKORESHEREZE]

Imikorere ya Clinical

Imikorere yubuvuzi bwa COVID-19 Antigen Rapid Test Cassette (Saliva) yashizweho mubushakashatsi buteganijwe hamwe ningero zegeranijwe n’abarwayi 628 ku giti cyabo (mu minsi 7 itangiye) hamwe n’abarwayi badafite ibimenyetso bakekwaho kuba COVID-19.

Incamake yamakuru ya COVID-19 Ikizamini cyihuta cya Antigen nkuko bikurikira:

Inzira ya RT-PCR (Ct) nigiciro cyibimenyetso bijyanye.Hasi ya Ct yerekana virusi iremereye.Ibyiyumvo byabazwe kubiciro bitandukanye bya Ct (Ct agaciroW37)

Antfgeno COVID-19		RT-PCR		Igiteranyo
Antfgeno COVID-19		Positivo	Negativo	Igiteranyo
HEO®	Positivo	172	0	172
HEO®	Negativo	3	453	456
Igiteranyo		175	453	628

Amasezerano meza ku ijana (PPA) = 98.28% (172/175), (95% CI: 95.08% ~ 99.41%)

Amasezerano mabi (NPA) = 100% (453/453), (95% CI: 99.15% ~ 100%)

PPA - Amasezerano meza ku ijana (Sensitivity)

NPA - Amasezerano Atari meza (Umwihariko)

Imipaka yo gutahura (Analytical Sensitivity)

Ubushakashatsi bwakoresheje virusi ya SARS-CoV-2 (Isolate Hong Kong / VM20001061 / 2020, NR-52282), ubushuhe budakora kandi bwinjira mu macandwe.Imipaka yo Kumenya (LoD) ni 8.6 X10²TCIDso / mL.

Kwambukiranya umusaraba (Umwihariko wo gusesengura)

Imyitwarire yumusaraba yasuzumwe no gupima mikorobe 32 zishobora gutera no gutera indwara zishobora kuba mu kanwa.

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

Nta cross-reactivite yagaragaye hamwe na virusi zikurikira mugihe zapimwe kuri concentration ya 1.0x10⁶PFU / mL: ibicurane A (H1N1), ibicurane A.

. 3, 4), virusi yubuhumekero, Enterovirus, Rhinovirus, Umuntu coronavirus 229E, Umuntu coronavirus OC43, Umuntu coronavirus NL63, Umuntu coronavirus HKU1.

Nta reaction-reaction yagaragaye hamwe na bagiteri zikurikira mugihe zapimwe kuri 1.0x10 'CFU / mL: Mycoplasma pneumoniae, Chlamy dia pneumoniae, Legionella pneumophila, grippe Haemophilus, Streptococcus pyogenes (itsinda A), Streptococcus pneumoniae, Candida albicans.St aureus.

Kwivanga

Ibintu bikurikira bishobora kwivanga byasuzumwe hamwe na COVID-19 Antigen Rapid Test Cassette (Amacandwe) yibitekerezo byerekanwe hepfo aha kandi wasangaga bitagira ingaruka kumikorere ya tegt.

Ibintu	Kwibanda	Ibintu	Kwibanda
Mucin	2%	Amaraso yose	4%
Benzocaine	5 mg / mL	Menthol	10 mg / mL
Saline izuru	15%	Fenilephrine	15%
Oxymetazoline	15%	Histamine dihydrochloride	10 mg / mL
Tobramycin	5 pg / mL	Mupirocin	10 mg / mL
Oseltamivir fosifate	10 mg / mL	Zanamivir	5 mg / mL
Arbidol	5 mg / mL	Ribavirin	5 mg / mL
Fluticasone	5%	Dexamethasone	5 mg / mL
Triamcinolone	10 mg / mL

Ingaruka nini cyane

COVID-19 Antigen Rapid Cassette (Saliva) yapimwe kugeza kuri 1.15x1 o 'TCIDso / mL ya SARS-CoV-2 idakora kandi nta ngaruka zifatika zagaragaye.

Hangzhou Heo Technology Co., Ltd.

Aderesi: Icyumba201, Inyubako3, No2073 Umuhanda wa Jinchang,

Umuhanda wa Liangzhu, Akarere ka Yuhang, Hangzhou, Ubushinwa Postcode ： 311113

Tel: 0086-571-87352763 E-imeri:52558565@qq.com

Lotus NL BV Aderesi: Koningin Julianaplein 10, le Verd,

2595AA, La Haye, Ubuholandi.E-imeri:Peter@lotusnl.com

Tel: +31644168999

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.

GUSOBANURA IBISUBIZO

Ibyiza

C T.

Imirongo ibiri iragaragara.Umurongo umwe wamabara ugaragara ubukana bwumurongo wikizamini.

Ibibi

Umurongo umwe wamabara ugaragara mukarere kagenzura (C), kandi nta murongo ugaragara mukarere kizamini (T).

Ntibyemewe

C T.

Kugenzura umurongo birananirana to Kugaragara. Ingano yikigereranyo idahagije cyangwa tekinike yuburyo bukwiye nimpamvu zishoboka zo kugenzura umurongo kunanirwa.Ongera usubiremo inzira hanyuma usubiremo ikizamini ukoresheje cassette nshya.Niba ikibazo gikomeje, hagarika gukoresha ubufindo ako kanya hanyuma ubaze abaguzi baho.

KUGENZURA UMUNTU

Igipimo cyo kugenzura ntabwo gitangwa niki gikoresho.Ariko, birasabwa ko igenzura ryiza kandi ribi ryageragezwa nkigikorwa cyiza cya laboratoire kugirango hemezwe inzira yikizamini no kugenzura imikorere ikwiye.

LIMITATIONS

• Ibicuruzwa bigarukira gutanga ibisobanuro byujuje ubuziranenge.Ubwinshi bwumurongo wikizamini ntabwo byanze bikunze bifitanye isano nubunini bwa antigen yikigereranyo.

• Ibisubizo bibi ntibibuza kwandura SARS-CoV-2 kandi niba ibimenyetso bihari ugomba kwihutira kwipimisha Binyuze muburyo bwa PCR.

• Muganga agomba gusobanura ibisubizo afatanije namateka yumurwayi, ibyagaragaye kumubiri, nubundi buryo bwo gusuzuma.

• Ibisubizo bibi byakuwe muri iki gitabo bigomba kwemezwa na PCR.Ingaruka mbi irashobora kubaho mugihe ubwinshi bwa antigene ya SARS-CoV-2 igaragara murugero iri munsi yurwego rwo gutahura, cyangwa virusi ikaba yarahinduye mutation ntoya ya aside amine mukarere ka epitope yamenyekanye na antibodiyite za monoclonal. ikoreshwa mu kizamini.

• Amaraso menshi cyangwa mucus birenze urugero rwa swab birashobora kubangamira imikorere kandi bishobora gutanga umusaruro mubi.

IBIKORWA BIKORWA

Imikorere ya Clinical

COVID-19 antigen		RT-PCR		Yose
COVID-19 antigen		Ibyiza	Ibibi	Yose
HEO®	Ibyiza	212	0	212
HEO®	Ibibi	3	569	572
Igiteranyo		215	569	784

PPA = 98.60% (212/215), (95% CI: 95,68% ~ 99,71%) NPA = 100% (569/569), (95% CI: 99.47% ~ 100%)

PPA - Amasezerano meza ku ijana (Sensitivity) NPA - Amasezerano mabi ku ijana (Umwihariko) 95% * Intera y'Icyizere

Iminsi kuva ibimenyetso	RT-PCR	TEKINOLOGIYA	Amasezerano (%)
0-3	95	92	96.84%
4-7	120	120	100%

CT Agaciro	RT-PCR	TEKINOLOGIYA	Amasezerano (%)
Ct≤30	42	42	100%
Ct≤32	78	78	100%
Ct≤35	86	85	98.84%
＜ 37	9	7	77,78%

Imipaka yo gutahura (Analytical Sensitivity)

Ubushakashatsi bwakoresheje virusi ya SARS-CoV-2 ifite umuco, ubushuhe budakorwa kandi bugera mu mazuru ya swab.Imipaka yo Kumenya (LoD) ni 1.0 × 102 TCID50 / 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 (H7N9), ibicurane A (H3N2), ibicurane B (B). Yamagata), ibicurane 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 ikurikira mugihe yapimwe kuri 1.0 × 107 CFU / mL: Mycoplasma pneumoniae, Chlamy- dia pneumoniae, Legionella pneumophila, grippe Haemophilus, Streptococus cus 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.

Ibintu	Kwibanda	Ibintu	Kwibanda
Mucin	2%	Amaraso yose	4%
Benzocaine	5 mg / mL	Menthol	10 mg / mL
Saline izuru	15%	Fenilephrine	15%
Oxymetazoline	15%	Mupirocin	10 mg / mL
Tobramycin	5 μg / mL	Zanamivir	5 mg / mL
Oseltamivir fosifate	10 mg / mL	Ribavirin	5 mg / mL
Arbidol	5 mg / mL	Dexamethasone	5 mg / mL
Fluticasone	5%	Histamine dihydrochloride	10 mg / mL
Triamcinolone	10 mg / mL	Histamine dihydrochloride	10 mg / mL

Ingaruka nini cyane

COVID-19 Antigen yihuta ya Cassette (Zahabu ya Colloidal) yapimwe kugeza 1.0 × 10 5 TCID50 / mL ya SARS-CoV-2 idakora kandi nta ngaruka zifatika zifatika zagaragaye.

Ikibazo Cyakunze Kubazwa

1.Ni ubuhe buryo SARS-CoV-2 Antigen yihuta ikora?Ikizamini ni ukumenya neza antigene ya SARS-CoV-2 muburyo bwo kwifashisha swab.Igisubizo cyiza cyerekana SARS-CoV-2 antigene ziboneka murugero.

Ikizamini gikwiye gukoreshwa ryari?

Antigen ya SARS-CoV-2 irashobora kugaragara mugihe cyanduye cyubuhumekero bukabije, birasabwa gukora ikizamini mugihe ibimenyetso birimo gutangira gitunguranye byibuze kimwe muribi bikurikira: inkorora, umuriro, guhumeka nabi, umunaniro, ubushake bwo kurya, myalgia.

Ibisubizo birashobora kuba atari byo?

Ibisubizo birasobanutse neza nkuko amabwiriza yubahwa neza.Nubwo bimeze bityo ariko, ibisubizo birashobora kuba atari byo niba urugero rwikitegererezo rudahagije cyangwa SARS-CoV-2 Antigen Rapid Ikizamini cyihuta mbere yo gukora ikizamini, cyangwa niba umubare wibitonyanga bikuramo bitarenze 3 cyangwa birenga 4. Usibye, kubera amahame yubudahangarwa. abigizemo uruhare, hariho amahirwe yo kubeshya mubibazo bidasanzwe.Buri gihe harasabwa inama na muganga kubizamini nkibi bishingiye ku mahame y’ubudahangarwa.

Nigute ushobora gusobanura ikizamini niba ibara nuburemere bwimirongo bitandukanye?Ibara nuburemere bwimirongo nta kamaro bifite kubisobanuro byo gusobanura.Imirongo igomba kuba imwe gusa kandi igaragara neza.Ikizamini kigomba gufatwa nkicyiza icyaricyo cyose ibara ryimbaraga zumurongo wikizamini.5.Ni iki ngomba gukora niba ibisubizo ari bibi?

Igisubizo kibi bivuze ko uri mubi cyangwa ko umutwaro wa virusi ari muke cyane

kumenyekana nikizamini.Ariko, birashoboka ko iki kizamini gitanga ibisubizo bibi bitari byo (bibi bibi) mubantu bamwe bafite COVID-19.Ibi bivuze ko ushobora kuba ufite COVID-19 nubwo ikizamini ari kibi.

Niba uhuye nibimenyetso nko kubabara umutwe, migraine, umuriro, gutakaza impumuro nziza nuburyohe, hamagara ikigo nderabuzima cyegereye ukoresheje amategeko yubuyobozi bwawe.Mubyongeyeho, urashobora gusubiramo ikizamini hamwe nibikoresho bishya.Mugihe ukekwa, subiramo ikizamini nyuma yiminsi 1-2, kuko coronavirus idashobora kugaragara neza mubice byose byanduye.Intera n’isuku bigomba kubahirizwa.Ndetse hamwe nibisubizo bibi, intera nisuku bigomba kubahirizwa, kwimuka / gutembera, kwitabira ibirori nibindi bigomba gukurikiza amabwiriza ya COVID yaho / ibisabwa.6.Ni iki ngomba gukora niba ibisubizo ari byiza?

Igisubizo cyiza bivuze ko hariho antigene ya SARS-CoV-2.Ibisubizo byiza bivuze ko bishoboka cyane ko ufite COVID-19.Ako kanya jya mu bwigunge ukurikije amabwiriza yaho hanyuma uhite ubariza umuganga rusange / umuganga cyangwa ishami ry’ubuzima ryaho ukurikije amabwiriza yinzego zibanze.Ibisubizo byawe bizagenzurwa nikizamini cya PCR hanyuma uzasobanurwe intambwe ikurikira.