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.

[ZINTHU ZOCHITIKA]

Magwiridwe Achipatala

Kuti muyerekezere kuyambika kwachipatala pakati pa COVID-19 Antigen Rapid Test Cassette ndi PCR comparotor, 628 swab ya mphuno inatengedwa kuchokera kwa odwala omwe akuwaganizira kuti ali ndi COVID-19. Chidule cha data ya COVID-19 Antigen Rapid Test Cassette (Nasal Swab) monga pansipa. .

COVID-19 antigen		RT-PCR		Zonse
COVID-19 antigen		Zabwino	Zoipa	Zonse
HEO®	Zabwino	172	0	172
HEO®	Zoipa	3	453	456
Zonse		175	453	628

PPA =98.28% (172/175), (95%CI: 95.08%~99.64%) NPA =100% (453/453), (95%CI: 99.34%~100%)

PPA - Positive Percent Agreement (Sensitivity) NPA - Negative Percent Agreement (Mwachidziwitso)

Malire Ozindikira (Kukhudzidwa Kwambiri)

Kafukufukuyu adagwiritsa ntchito kachilombo koyambitsa matenda a SARS-CoV-2 (Isolate USA-WA1/2020 NR- 52287), yomwe imakhala yosagwira ntchito komanso yothiridwa munsalu ya m'mphuno.Malire a Kuzindikira (LoD) ndi 1.0 × 10²TCID₅₀/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 cross-reactivity omwe adawonedwa ndi ma virus otsatirawa atayesedwa pamlingo wa 1.0 × 106 PFU/mL: Influenza A (H1N1), Influenza A (H1N1pdm09), Fuluwenza A (H3N2), Fuluwenza B (Yamagata), Fuluwenza 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, Candida pneumoniae, Candida pneumoniae, 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.

Kukhazikika kwa Mankhwala

Mucin 2%

Benzocaine 5 mg/mL Saline nasal utsi 15%

Oxymetazoline 15%

Tobramycin 5 μg/mL Oseltamivir phosphate 10 mg/mL

Arbidol 5 mg/mL

Fluticasone propionate 5%

Triamcinolone 10 mg/mL

Mwazi wonse 4%

Menthol 10 mg/mL

Phenylephrine 15%

Mupirocin 10 mg/mL

Zanamivir 5 mg/mL

Ribavirin 5 mg/mL

Dexamethasone 5 mg/mL

Histamine 10 mg/mL dihydrochloride

Mlingo waukulu wa Hook Effect

Makaseti a COVID-19 Antigen Rapid Test (Colloidal Gold) adayesedwa mpaka 1.0×10⁵TCID50/mL ya inactivated SARS-CoV-2 ndipo palibe zotsatira za mbedza zapamwamba zomwe zidawonedwa.

Mlozera wa Zizindikiro