Opanga ndi ogulitsa makaseti a Antigen Rapid Test Cassette (Colloidal Gold) yogulitsa COVID-19 |HEO

COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)

Kufotokozera Kwachidule:

Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

ZOYENERA KUGWIRITSA NTCHITO

Kaseti ya COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) ndi lateral flow immunoassay yopangidwira kuzindikira zamtundu wa SARS-CoV-2 nucleocapsid antigens mu swab ya m'mphuno kuchokera kwa anthu omwe akuwaganizira kuti ali ndi COVID-19 ndi othandizira awo azaumoyo.

Zotsatira ndizomwe zimadziwika ndi SARS-CoV-2 nucleocapsid antigen.Antigen nthawi zambiri imapezeka mu swab ya m'mphuno panthawi yovuta kwambiri ya matenda.Zotsatira zabwino zimasonyeza kukhalapo kwa tizilombo toyambitsa matenda, koma mgwirizano wachipatala ndi mbiri ya odwala ndi zina zowunikira ndizofunikira kuti mudziwe momwe matenda alili.Zotsatira zabwino sizimaletsa matenda a bakiteriya kapena kupatsirana ndi ma virus ena.Wothandizira wapezeka sangakhale wotsimikizika wa matenda.

Zotsatira zoyipa sizimaletsa matenda a SARS-CoV-2 ndipo siziyenera kugwiritsidwa ntchito ngati maziko okha a chithandizo kapena zisankho zowongolera odwala, kuphatikiza zisankho zowongolera matenda.Zotsatira zoyipa ziyenera kuganiziridwa potengera zomwe wodwala wakumana nazo posachedwa, mbiri yakale komanso kupezeka kwa zizindikiro zachipatala zomwe zimagwirizana ndi COVID-19, ndikutsimikiziridwa ndi kuyesa kwa maselo, ngati kuli kofunikira pakuwongolera odwala.Chidachi ndi chogwiritsidwa ntchito kunyumba ndi anthu wamba omwe si a labotale (monga kunyumba kwa munthu kapena malo ena osakhala achikhalidwe monga maofesi, zochitika zamasewera, masukulu ndi zina).Zotsatira zoyezetsa za zidazi ndizongowona zachipatala zokha.Ndi bwino kuchita kusanthula mwatsatanetsatane za chikhalidwe zochokera odwala mawonetseredwe matenda ndi zina zasayansi mayesero.

CHIDULE

Novel coronaviruses (SARS-CoV-2) ndi amtundu wa β.COVID-19 ndi matenda opatsirana pachimake kupuma.Nthawi zambiri anthu amavutika.Pakadali pano, odwala omwe ali ndi kachilombo ka coronavirus ndiye gwero lalikulu la matenda;anthu omwe ali ndi matenda asymptomatic amathanso kukhala gwero lopatsirana.Malingana ndi kafukufuku wamakono wa epidemiological, nthawi yoyamwitsa ndi masiku 1 mpaka 14, makamaka masiku 3 mpaka 7.The mawonetseredwe aakulu monga malungo, kutopa ndi youma chifuwa.Kutsekeka kwa mphuno, mphuno, zilonda zapakhosi, myalgia ndi kutsekula m'mimba zimapezeka nthawi zingapo.

MFUNDO

COVID-19 Antigen Rapid Test Cassette (Nasal Swab) ndi lateral flow immunoassay kutengera mfundo ya sangweji ya ma antibody awiri.SARS-CoV-2 nucleocapsid protein monoclonal antibody yolumikizidwa ndi ma microparticles amtundu amagwiritsidwa ntchito ngati chodziwikiratu komanso kupopera mbewu mankhwalawa pa conjugation pad.Pakuyesa, ma antigen a SARS-CoV-2 pachitsanzo amalumikizana ndi ma anti-SARS-CoV-2 ophatikizidwa ndi ma microparticles amitundu omwe amapanga antigen-antibody olembedwa kuti ndizovuta.Zovutazi zimasuntha pa nembanemba kudzera pa capillary action mpaka mzere woyeserera, pomwe udzagwidwa ndi SARS-CoV-2 nucleocapsid protein monoclonal antibody.Mzere woyesera wamitundu (T) ukhoza kuwoneka pazenera lazotsatira ngati ma antigen a SARS-CoV-2 alipo pachitsanzocho.Kusakhalapo kwa mzere wa T kukuwonetsa zotsatira zoyipa.Mzere wowongolera (C) umagwiritsidwa ntchito poyang'anira njira, ndipo uyenera kuwonekera nthawi zonse ngati mayesowo achitidwa moyenera.

CHENJEZO NDI CHENJEZO

•Kwa Self testing in vitro diagnostic use only.tset cassette iyi ndi yogwiritsidwa ntchito kamodzi kokha ndipo singagwiritsidwenso ntchito kapena kugwiritsidwa ntchito ndi anthu angapo.

•Musagwiritse ntchito mankhwalawa ngati njira yokhayo yodziwira kapena kupatula matenda a SARS-CoV-2 kapena kudziŵitsa kuti muli ndi kachilombo ka COVID-19.

•Chonde werengani zonse zomwe zili mu kapepalaka musanapange mayeso.

•Musagwiritse ntchito mankhwalawa tsiku litatha.

•Kaseti yoyesera ikhalebe muthumba lomata mpaka itagwiritsidwa ntchito.

•Zitsanzo zonse ziyenera kuonedwa ngati zowopsa ndikusamalidwa mofanana ndi mankhwala opatsirana.

•Mayeso a ana ndi achinyamata akuyenera kugwiritsidwa ntchito ndi munthu wamkulu.

•Kaseti yoyeserera yomwe yagwiritsidwa ntchito iyenera kutayidwa molingana ndi malamulo aboma, boma komanso mdera lanu.

•Musagwiritse ntchito mayeso kwa ana osapitirira zaka ziwiri.

•Ana ang'onoang'ono amayenera kumeta mothandizidwa ndi munthu wina wamkulu.

•Sambani m'manja bwinobwino musanagwire kapena mukamaliza.

COMPOSITION

Zida Zoperekedwa

• Makaseti Oyesa: kaseti iliyonse yokhala ndi desiccant m'thumba lazojambulazo

•Zokonzeratu M'zigawo:

•Sterilized Swabs: Gwiritsani ntchito swab wosabala kamodzi potengera zitsanzo

• Phukusi Lowetsani

Zinthu Zofunika Koma Zosaperekedwa

• Chowerengera nthawi

KUSINTHA NDI KUKHALA

•Kusunga monga mmatumba mu thumba losindikizidwa kutentha (4-30 ℃ kapena 40-86 ℉).Zidazi ndi zokhazikika mkati mwa tsiku lotha ntchito lomwe lidasindikizidwa.

•Mukatsegula thumba, kuyezetsa kumayenera kugwiritsidwa ntchito pasanathe ola limodzi.Kusungidwa kwanthawi yayitali kumalo otentha ndi achinyezi kungayambitse kuwonongeka kwa zinthu.

•OSATI KUMUMITSA.

MFUNDO

Zitsanzo zomwe zapezedwa msanga pamene zizindikiro zimayamba zimakhala ndi ma virus apamwamba kwambiri;zitsanzo zopezedwa pambuyo pa masiku asanu azizindikiro zimatha kutulutsa zotsatira zoyipa poyerekeza ndi kuyesa kwa RT-PCR.Kusakwanira kwa zitsanzo, kusamalidwa molakwika ndi/kapena zoyendera zitha kubweretsa zotsatira zabodza;Choncho, kuphunzitsa kusonkhanitsa zitsanzo kumalimbikitsidwa kwambiri chifukwa cha kufunikira kwa khalidwe lachitsanzo kuti mupeze zotsatira zolondola.Mtundu wovomerezeka woyezetsa ndi mtundu wamba wa mphuno wachindunji wopezedwa ndi njira yosonkhanitsira nares wapawiri.Konzani chubu chochotsa molingana ndi Njira Yoyesera ndikugwiritsa ntchito swab wosabala yomwe yaperekedwa muzotengerazo kuti mutolere zitsanzo.

Kutolere Zitsanzo za Nasal Swab

1.Chotsani swab mu phukusi.

2. Pendekerani mutu wa wodwala kumbuyo pafupifupi 70 °.

3.1-2Potembenuza pang'onopang'ono swab, ikani swab pafupifupi 2.5 cm (1 inchi) mumphuno mpaka kukana kukumane ndi ma turbinate.

4.Sungani swab kangapo ku khoma lamphuno ndikubwerezanso mumphuno ina pogwiritsa ntchito swab yomweyo.

Zitsanzo Zoyendera ndi Kusungirako

Osabwezera swab ku paketi yoyambirira ya swab.Zitsanzo zomwe zangotengedwa kumene ziyenera kukonzedwa posachedwa, koma pasanathe ola limodzi chitsanzo chatoleredwa.

NJIRA YOYESA

Zindikirani:Lolani makaseti oyesera, ma reagents ndi zitsanzo kuti zifanane ndi kutentha kwachipinda (15-30 ℃ kapena 59-86 ℉) musanayesedwe.

1.Ikani chubu chochotsa m'malo ogwirira ntchito.

2.Chotsani chosindikizira chosindikizira cha aluminiyamu pamwamba pa chubu chochotsa chomwe chili ndi chubu chochotsamo.

3.Sampling ikutanthauza gawo la 'Specimen Collection'.

4.Ikani chitsanzo cha swab ya m'mphuno mu chubu chochotsa chomwe chili ndi reagent yochotsa.Pereka swab osachepera kasanu ndikukankhira mutu pansi ndi mbali ya chubu chochotsa.Siyani swab ya m'mphuno mu chubu chochotsa kwa mphindi imodzi.

5.Chotsani swab ya m'mphuno kwinaku mukufinya mbali za chubu kuti mutenge madzi kuchokera ku swab.Yankho lochotsedwa lidzagwiritsidwa ntchito ngati chitsanzo choyesera.6.Kuphimba chubu chochotsa ndi dontho lachitsulo mwamphamvu.

7.Chotsani makaseti oyesera m'thumba lomata.

8.Sinthani chubu chotsitsa cha specimen, kugwira chubu molunjika, tumizani madontho a 3 (pafupifupi 100 μL) pang'onopang'ono ku chitsime cha chitsanzo (S) cha kaseti yoyesera, ndiye yambani chowerengera.

9.Dikirani kuti mizere yamitundu iwonekere.Tanthauzirani zotsatira za mayeso pa mphindi khumi ndi zisanu.Osawerenga zotsatira pakadutsa mphindi 20.

KUMASULIRIDWA KWA ZOTSATIRA

Zabwino

C T

Mizere iwiri ikuwonekera.Mzere umodzi wachikuda umawoneka wa mphamvu ya mzere woyesera.

Zoipa

Mzere umodzi wachikuda umapezeka pamalo olamulira (C), ndipo palibe mzere womwe umapezeka pagawo loyesa (T).

Zosalondola

C T

Kulamulira mzere amalephera to kuwonekera. Kusakwanira kwa kuchuluka kwa zitsanzo kapena njira zolakwika ndizo zifukwa zomwe zimalepheretsa mzere wowongolera.Unikaninso ndondomekoyi ndikubwereza kuyesanso pogwiritsa ntchito kaseti yatsopano yoyesera.Vuto likapitilira, siyani kugwiritsa ntchito maere nthawi yomweyo ndipo funsani wofalitsa wapafupipafupi.

KUKHALA KWAKHALIDWE

Kuwongolera kwadongosolo kumaphatikizidwa muyeso.Mzere wachikuda womwe ukuwoneka m'chigawo chowongolera (C) umatengedwa ngati njira yoyendetsera mkati.Imatsimikizira kuchuluka kokwanira kwa sampuli, kupukuta kokwanira kwa membrane ndi njira yoyenera.

Zowongolera siziperekedwa ndi zida izi.Komabe, tikulimbikitsidwa kuti zowongolera zabwino ndi zoyipa ziyesedwe ngati machitidwe abwino a labotale kuti atsimikizire njira yoyezera ndikuwonetsetsa kuti mayesowo achita bwino.

ZOPHUNZITSA

•Zogulitsazo zimangopereka chidziwitso chodziwika bwino.Kuchuluka kwa mzere woyesera sikumayenderana ndi kuchuluka kwa ma antigen a zitsanzo.

•Zotsatira zoyipa sizilepheretsa kutenga kachilombo ka SARS-CoV-2 ndipo ngati zizindikiro zilipo muyenera kufufuzanso nthawi yomweyo Kudzera pa Njira ya PCR.

•Dokotala ayenera kutanthauzira zotsatira zake mogwirizana ndi mbiri ya wodwalayo, zomwe wapeza, ndi njira zina zowunikira.

• Zotsatira zoyipa zomwe zapezedwa kuchokera ku Kit zikuyenera kutsimikiziridwa ndi PCR.Chotsatira choyipa chitha kuchitika ngati kuchuluka kwa ma antigen a SARS-CoV-2 omwe ali pachitsanzo ali pansi pa gawo loyesera, kapena kachilomboka kakhala kakusintha pang'ono amino acid m'chigawo cha epitope chomwe chimadziwika ndi ma antibodies a monoclonal. zogwiritsidwa ntchito muyeso.

•Magazi ochulukira kapena ntchofu pa swab akhoza kusokoneza kagwiritsidwe ntchito kake ndipo angapereke zotsatira zabodza.

ZINTHU ZOCHITIKA

Magwiridwe Achipatala

COVID-19 antigen		RT-PCR		Totale
COVID-19 antigen		Zabwino	Zoipa	Totale
HEO®	Zabwino	212	0	212
HEO®	Zoipa	3	569	572
Zonse		215	569	784

PPA =98.60% (212/215), (95%CI: 95.68%~99.71%) NPA =100% (569/569), (95%CI: 99.47%~100%)

PPA - Positive Percent Agreement (Sensitivity) NPA - Negative Percent Agreement (Specific) 95% *Zigawo Zachikhulupiriro

Masiku chiyambireni chizindikiro	RT-PCR	HEO TECHNOLOGY	Mgwirizano (%)
0-3	95	92	96.84%
4-7	120	120	100%

Mtengo wa CT	RT-PCR	HEO TECHNOLOGY	Mgwirizano (%)
Ct≤30	42	42	100%
Ct≤32	78	78	100%
Ct≤35	86	85	98.84%
＜37	9	7	77.78%

Malire Ozindikira (Kukhudzidwa Kwambiri)

Kafukufukuyu adagwiritsa ntchito kachilombo koyambitsa matenda a SARS-CoV-2, komwe sikumatenthedwa ndikulowa m'mphuno.Malire a Kuzindikira (LoD) ndi 1.0 × 102 TCID50/mL.

Cross Reactivity (Analytical Specificity)

Cross reactivity inayesedwa poyesa 32 commensal ndi tizilombo toyambitsa matenda zomwe zingakhalepo m'mphuno.Palibe mtanda-reactivity unkawonedwa ndi recombinant MERS-CoV NP mapuloteni pamene anayesedwa pa ndende ya 50 pg/mL.

Palibe ma virus omwe adawonedwa ndi ma virus otsatirawa atayesedwa pamlingo wa 1.0 × 106 PFU/mL: Fuluwenza A (H1N1), Influenza A (H1N1pdm09), Fuluwenza A (H7N9), Fuluwenza A (H3N2), Fuluwenza B ( Yamagata), Influenza B (Victoria), Adenovirus (mtundu 1, 2, 3, 5, 7, 55), Human metapneumovirus,

Parainfluenza virus (mtundu 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

Palibe mabakiteriya otsatirawa omwe adayesedwa pamlingo wa 1.0 × 107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (gulu A), Streptococcus pneumoniae, albicans Staphylococcus aureus.

Kusokoneza

Zinthu zotsatirazi zomwe zitha kusokoneza zidawunikidwa ndi COVID-19 Antigen Rapid Test Cassette (Nasal Swab) pazigawo zomwe zalembedwa pansipa ndipo zidapezeka kuti sizikhudza momwe mayeso akuyendera.

Mankhwala	Kukhazikika	Mankhwala	Kukhazikika
Mucin	2%	Mwazi wonse	4%
Benzocaine	5 mg/mL	Menthol	10 mg/mL
Saline nasal spray	15%	Phenylephrine	15%
Oxymetazoline	15%	Mupirocin	10 mg/mL
Tobramycin	5 μg/mL	Zanamivir	5 mg/mL
Oseltamivir phosphate	10 mg/mL	Ribavirin	5 mg/mL
Arbidol	5 mg/mL	Dexamethasone	5 mg/mL
Fluticasone propionate	5%	Histamine dihydrochloride	10 mg/mL
Triamcinolone	10 mg/mL	Histamine dihydrochloride	10 mg/mL

Mlingo waukulu wa Hook Effect

Kaseti ya COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) idayesedwa mpaka 1.0×10 5 TCID50 /mL ya SARS-CoV-2 yosagwira ntchito ndipo palibe mbedza yamphamvu kwambiri yomwe idawonedwa.

Mafunso Ofunsidwa Kawirikawiri

1.Kodi kuyesa kwa SARS-CoV-2 Antigen Rapid kumagwira ntchito bwanji?Mayesowa ndi ozindikira kuti ma antigen a SARS-CoV-2 ali m'zitsanzo zodzitolera zokha.Zotsatira zabwino zikuwonetsa ma antigen a SARS-CoV-2 omwe amapezeka pachitsanzocho.

Kodi mayesowo agwiritsidwe ntchito liti?

SARS-CoV-2 antigen amatha kudziwika pachimake kupuma thirakiti matenda, tikulimbikitsidwa kuthamanga mayeso pamene zizindikiro kuphatikizapo mwadzidzidzi isanayambike chimodzi mwa zotsatirazi: chifuwa, kutentha thupi, kupuma movutikira, kutopa, kuchepa chilakolako, myalgia.

Kodi zotsatira zake zingakhale zolakwika?

Zotsatira zake ndi zolondola malinga ndi malangizo omwe amalemekezedwa mosamala.Komabe, zotsatira zake zitha kukhala zolakwika ngati sampling volume yosakwanira kapena SARS-CoV-2 Antigen Rapid Test inyowa mayeso asanayesedwe, kapena ngati kuchuluka kwa madontho ocheperako ndi osakwana 3 kapena kupitilira 4. Kupatula apo, chifukwa cha mfundo za immunological okhudzidwa, pali mwayi wa zotsatira zabodza nthawi zina.Kukambirana ndi dokotala nthawi zonse kumalimbikitsidwa paziyeso zotere zochokera ku mfundo za immunological.

Momwe mungatanthauzire mayeso ngati mtundu ndi kukula kwa mizere ndizosiyana?Mtundu ndi mphamvu ya mizere ilibe kufunikira pakutanthauzira zotsatira.Mizere iyenera kukhala yofanana komanso yowonekera bwino.Chiyesocho chiyenera kuonedwa ngati chabwino, kaya ndi mtundu wamtundu wanji wa mzere woyesera.5.Kodi ndiyenera kuchita chiyani ngati zotsatira zake zili zopanda pake?

Zotsatira zoyipa zikutanthauza kuti mulibe kachilombo kapena kuti kuchuluka kwa ma virus ndikotsika kwambiri

kuti azindikiridwe ndi mayeso.Komabe, ndizotheka kuti mayesowa apereke zotsatira zolakwika zomwe sizolondola (zabodza) mwa anthu ena omwe ali ndi COVID-19.Izi zikutanthauza kuti mutha kukhalabe ndi COVID-19 ngakhale mayeso alibe.

Ngati mukukumana ndi zizindikiro monga kupweteka kwa mutu, mutu waching'alang'ala, kutentha thupi, kutaya fungo ndi kukoma, funsani kuchipatala chapafupi pogwiritsa ntchito malamulo a boma lanu.Kuphatikiza apo, mutha kubwereza mayesowo ndi zida zatsopano zoyeserera.Ngati mukukayikira, bwerezani mayesowo patatha masiku 1-2, chifukwa coronavirus siyingadziwike m'magawo onse a matenda.Malamulo a mtunda ndi ukhondo ayenera kuwonedwabe.Ngakhale zotsatira zoyipa zitayesedwa, malamulo a mtunda ndi ukhondo ayenera kutsatiridwa, kusamuka/kuyendayenda, kupita ku zochitika ndi zina zotero ziyenera kutsatira malangizo/zofunikira za COVID kwanuko.6.Kodi ndiyenera kuchita chiyani ngati zotsatira zake zili zabwino?

Zotsatira zabwino zikutanthauza kukhalapo kwa ma antigen a SARS-CoV-2.Zotsatira zabwino zikutanthauza kuti ndizotheka kuti muli ndi COVID-19.Nthawi yomweyo dzipatuleni molingana ndi malangizo amdera lanu ndipo funsani sing'anga / dokotala kapena dipatimenti yazaumoyo mdera lanu malinga ndi malangizo a aboma amdera lanu.Zotsatira zanu zidzawunikidwa ndi kuyesa kotsimikizira kwa PCR ndipo mudzafotokozedwa masitepe otsatirawa.