COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) Setšoantšo se Feariloeng

Khasete ea Tlhahlobo e Potlako ea COVID-19 Antigen (Colloidal Gold)

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TŠEBELETSO TŠEBELETSO

The COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) ke lateral flow immunoassay e reretsoeng ho lemoha boleng ba SARS-CoV-2 nucleocapsid antigens ho swab ea nko ho tsoa ho batho ba belaelloang ba COVID-19 ke mofani oa bona oa tlhokomelo ea bophelo.

Liphetho ke tsa ho tsebahatsa SARS-CoV-2 nucleocapsid antigen.Antigen hangata e ka bonoa ka nasal swab nakong ea boemo bo matla ba tšoaetso.Liphetho tse ntle li bontša ho ba teng ha li-antigens tsa kokoana-hloko, empa kamano ea kliniki le histori ea mokuli le boitsebiso bo bong ba ho hlahloba hoa hlokahala ho fumana boemo ba tšoaetso.Liphetho tse ntle ha li thibele tšoaetso ea baktheria kapa tšoaetso e kopanetsoeng le livaerase tse ling.Moemeli o fumanoeng e kanna ea se be sesosa se hlakileng sa lefu.

Liphetho tse mpe ha li qhelele ka thoko tšoaetso ea SARS-CoV-2 'me ha ea lokela ho sebelisoa e le eona feela motheo oa liqeto tsa kalafo kapa tsa taolo ea bakuli, ho kenyeletsoa liqeto tsa taolo ea ts'oaetso.Liphetho tse mpe li lokela ho nahanoa molemong oa ho pepeseha ha mokuli haufinyane, nalane le boteng ba matšoao a kliniki le matšoao a lumellanang le COVID-19, 'me a netefatsoe ka tlhahlobo ea limolek'hule, ha ho hlokahala bakeng sa taolo ea mokuli.Setsi sena se sebelisoa ke batho bao e seng ba laboratori (joalo ka lehae la motho kapa libaka tse ling tseo e seng tsa setso joalo ka liofisi, liketsahalo tsa lipapali, likolo joalo-joalo).Liphetho tsa tlhahlobo ea khithi ena ke tsa litšupiso tsa bongaka feela.Ho kgothaletswa ho etsa tlhahlobo e felletseng ea boemo bo ipapisitseng le matšoao a kliniki a bakuli le liteko tse ling tsa laboratori.

KAKARETSO

Novel coronaviruses (SARS-CoV-2) ke ea mofuta oa β.COVID-19 ke lefu le tšoaetsanoang le matla la ho hema.Batho ka kakaretso ba hlaseleha habonolo.Hajoale, bakuli ba tšoaelitsoeng ke coronavirus e ncha ke mohloli o ka sehloohong oa ts'oaetso;batho ba nang le tšoaetso ea asymptomatic le bona e ka ba mohloli oa tšoaetso.Ho ipapisitsoe le lipatlisiso tsa morao-rao tsa lefu la seoa, nako ea ho incubation ke matsatsi a 1 ho isa ho a 14, haholo matsatsi a 3 ho isa ho a 7.Lipontšo tse ka sehloohong li kenyelletsa feberu, mokhathala le ho khohlela ho omileng.Ho tsubella nko, nko, 'metso o bohloko, myalgia le letšollo li fumanoa maemong a seng makae.

MOLAOMOTHEO

The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) ke lateral flow immunoassay e thehiloeng holim'a molao-motheo oa mokhoa oa sandwich oa li-antibody tse peli.SARS-CoV-2 nucleocapsid protheine monoclonal antibody e kopantsoeng le li-microparticles tsa mebala e sebelisoa e le sebui le ho fafatsoa holim'a conjugation pad.Nakong ea tlhahlobo, SARS-CoV-2 antigen ea mohlala e sebelisana le anti-SARS-CoV-2 antibody e kopantsoeng le li-microparticles tsa mebala tse etsang antigen-antibody e ngotsoeng e rarahaneng.Motsoako ona o falla ka har'a membrane ka ts'ebetso ea capillary ho fihlela mohala oa teko, moo o tla ts'oaroa ke SARS-CoV-2 nucleocapsid protein monoclonal antibody e kentsoeng pele.Mohala oa liteko oa mebala (T) o tla bonahala fensetereng ea sephetho haeba li-antigen tsa SARS-CoV-2 li le teng mohlaleng oo.Ho ba sieo ha mohala oa T ho fana ka maikutlo a phello e mpe.Mohala oa taolo (C) o sebelisoa bakeng sa taolo ea ts'ebetso, 'me o lokela ho hlaha kamehla haeba mokhoa oa tlhahlobo o etsoa ka nepo.

TLHOKOMELISO LE TS'ELISO

•For Self testing in vitro diagnostic use only.Khasete ena ea tset ke ea ho sebelisoa hanngoe feela 'me e ke ke ea sebelisoa hape kapa ea sebelisoa ke batho ba bangata.

•Se ke oa sebelisa sehlahisoa sena e le eona feela motheo oa ho hlahloba kapa ho behella ka thoko tšoaetso ea SARS-CoV-2 kapa ho tsebisa boemo ba tšoaetso ea COVID-19.

•Ka kopo bala lintlha tsohle tse pampitšaneng ena pele u etsa tlhahlobo.

•Se ke oa sebelisa sehlahisoa sena kamora letsatsi la ho felloa ke nako.

•Khasete ea teko e lokela ho lula ka mokotleng o koetsoeng ho fihlela e sebelisoa.

• Mehlala eohle e lokela ho nkoa e le kotsi 'me e tšoaroe ka mokhoa o ts'oanang le oa ts'oaetso.

• Teko ea bana le bacha e lokela ho sebelisoa le motho e moholo.

•Khasete ea teko e sebelisitsoeng e lokela ho lahloa ho latela melao ea mmuso, ea naha le ea lehae.

•Se sebelise tlhahlobo ho bana ba ka tlase ho lilemo tse 2.

•Bana ba banyenyane ba lokela ho hlatsuoa ka thuso ea motho e moholo oa bobeli.

• Hlapa matsoho hantle pele le ka mor'a ho tšoara.

MOTSAMAI

Thepa e Fanoeng

•Likhasete tsa Teko: k'hasete ka 'ngoe e nang le desiccant ka mokotleng o mong oa foil

•Lisebelisuoa tsa ho phunya tse seng li paketsoe esale pele:

•Sterilized Swabs: sebelisa swab e le 'ngoe feela bakeng sa pokello ea mohlala

•Pakete Kenya

Lintho Tse Hlokehang Empa li sa Fanoe

•Sebala nako

POLOKO LE TSAMAISO

• Boloka e phuthetsoe ka mokotleng o tiisitsoeng ka mocheso (4-30℃ kapa 40-86℉).Thepa e tsitsitse nakong ea ho felloa ke nako e hatisitsoeng ho laible.

• Hang ha u bula mokotla, tlhahlobo e lokela ho sebelisoa nakong ea hora e le 'ngoe.Ho pepesehela nako e telele tikolohong e chesang le e mongobo ho tla baka ho senyeha ha lihlahisoa.

• U SE KE UA HOIMA.

MOEKETSI

Mehlala e fumanoeng pele ho nako ha matšoao a qala e tla ba le li-titer tse phahameng ka ho fetisisa tsa vaerase;mehlala e fumanoeng ka mor'a matsatsi a mahlano a matšoao a ka 'na a hlahisa liphello tse mpe ha li bapisoa le tlhahlobo ea RT-PCR.Pokello e sa lekaneng ea mohlala, ho tšoara mehlala e fosahetseng le/kapa lipalangoang li ka hlahisa litholoana tse fosahetseng;ka hona, koetliso ea pokello ea mehlala e khothaletsoa haholo ka lebaka la bohlokoa ba boleng ba mohlala ho fumana liphetho tse nepahetseng tsa liteko.Mofuta o amohelehang oa mohlala bakeng sa tlhahlobo ke mohlala o tobileng oa nasal swab o fumanoang ka mokhoa oa ho bokella li-nares tse peli.Lokisetsa tšupu ea ho ntša ho ea ka Mokhoa oa Teko 'me u sebelise swab e hloekisitsoeng e fanoeng ka har'a khiti bakeng sa pokello ea mohlala.

Pokello ea Mohlala oa Nasal Swab

1.Tlosa swab ho tswa ho sephutheloana.

2.Sekisa hlooho ea mokuli morao hoo e ka bang 70°.

3.1-2Ha u ntse u potoloha swab ka bonolo, kenya swab e ka bang 2.5 cm (1 inch) ka har'a nko ho fihlela khanyetso e kopana le li-turbinate.

4. Fetolela sekoti ka makhetlo a 'maloa khahlanong le lebota la nko 'me u phete ka nkong e' ngoe u sebelisa sesepa se tšoanang.

Mohlala oa Lipalangoang le Polokelo

Se ke oa khutlisetsa swab ho pakete ea pele ea swab.Mehlala e sa tsoa bokelloa e lokela ho sebetsoa kapele kamoo ho ka khonehang, empa pele ho hora e le 'ngoe ka mor'a pokello ea mohlala.

TS'ELISO MOKHOA

Hlokomela:Lumella lik'hasete tsa teko, li-reagents le mehlala ho lumellana le mocheso oa kamore (15-30℃ kapa 59-86℉) pele ho teko.

1.Beha tube ea ho ntšoa sebakeng sa mosebetsi.

2. Hlakola tiiso ea foil ea aluminium ho tloha ka holim'a tube ea ho ntša e nang le tube ea ho ntša e nang le buffer ea ho ntša.

3.Sampling e bua ka karolo ea 'Specimen Collection'.

4.Kenya mohlala oa swab ea nko ka har'a tube ea ho ntša e nang le reagent ea ho ntša.Rōlela sesepa bonyane ka makhetlo a 5 ha u ntse u hatella hlooho ka tlase le lehlakoreng la tube ea ho ntša.Tlohela lesela la nko ka har'a tube ea ho ntša motsotso o le mong.

5.Tlosa lesela la nko ha u ntse u pepeta mahlakoreng a tube ho ntša mokelikeli ho tsoa ho swab.Tharollo e nkiloeng e tla sebelisoa e le mohlala oa tlhahlobo.6.Koahela tube ea ho ntša ka ntlha ea dropper ka thata.

7.Tlosa khasete ea teko mokotleng o tiisitsoeng.

8.Ho fetola tube ea ho ntša mohlala, ho tšoara tube e otlolohile, fetisetsa marotholi a 3 (hoo e ka bang 100 μL) butle-butle ho ea ho mohlala oa hantle (S) oa k'hasete ea teko, ebe o qala nako.

9.Emela hore mela e mebala e hlahe.Hlalosa liphetho tsa liteko ka metsotso e 15.Se ke oa bala liphetho kamora metsotso e 20.

[DITLHAKISO TSA SEBETSI]

Ts'ebetso ea Clinical

Ho hakanya tšebetso ea pele ea bongaka lipakeng tsa Cassette ea Tlhahlobo e Potlako ea COVID-19 le PCR comparotor, linko tse 628 li ile tsa bokelloa ho tsoa ho bakuli ba neng ba belaelloa ka COVID-19. Kakaretso ea data ea COVID-19 Antigen Rapid Test Cassette (Nasal Swab) joalo ka tlase. .

COVID-19 antigen		RT-PCR		Kakaretso
COVID-19 antigen		E ntle	E mpe	Kakaretso
HEO®	E ntle	172	0	172
HEO®	E mpe	3	453	456
Kakaretso		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 (Specifity)

Moeli oa ho Lemoha (Boikutlo ba Analytical)

Boithuto bona bo sebelisitse kokoana-hloko ea SARS-CoV-2 (Isolate USA-WA1/2020 NR- 52287), e sa sebetseng mocheso 'me e tšeloa ka har'a mohlala oa swab ea nko.Moeli oa ho Lemoha (LoD) ke 1.0 ×10²TCID₅₀/mL.

Cross Reactivity (Analytical Specificity)

Cross reactivity e ile ea hlahlojoa ka ho hlahloba likokoana-hloko tse 32 tsa commensal le pathogenic tse ka 'nang tsa e-ba teng sebakeng sa nko.

Ha ho cross-reactivity e ileng ea hlokomeloa ka protheine ea MERS-CoV NP ha e lekoa ka bongata ba 50 pg / mL.

Ha ho cross-reactivity e ileng ea bonoa ka livaerase tse latelang ha li ne li lekoa ka bongata ba 1.0×106 PFU/mL: Influenza A (H1N1), Influenza A (H1N1pdm09), Influenza A (H3N2), Influenza B (Yamagata), Influenza B ( Victoria), Adenovirus (mofuta oa 1, 2, 3, 5, 7, 55), metapneumovirus ea motho,

Kokoana ea parainfluenza (mofuta oa 1, 2, 3, 4), kokoana ea phefumoloho ea syncytial, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

Ha ho cross-reactivity e ileng ea bonoa ka libaktheria tse latelang ha li ne li lekoa ka bongata ba 1.0 × 107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (sehlopha A), Streptococcus pneumoniae, Candida pneumoniae, Candida pneumoniae, Staphylococcus aureus.

Tšitiso

Lintho tse latelang tse ka bang teng tsa tšitiso li hlahlobiloe ka Khasete ea Tlhahlobo e Potlakileng ea COVID-19 (Nasal Swab) maemong a thathamisitsoeng ka tlase 'me ho fumanoe hore ha e ame ts'ebetso ea liteko.

Tšebeliso ea Lithethefatsi

Mucin 2%

Benzocaine 5 mg/mL Saline nasal spray 15%

Oxymetazoline 15%

Tobramycin 5 μg/mL Oseltamivir phosphate 10 mg/mL

Arbidol 5 mg/mL

Fluticasone propionate 5%

Triamcinolone 10 mg/mL

Mali a felletseng 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

Hook Effect ea tekanyo e phahameng

K'hasete ea Tlhahlobo e Potlakileng ea COVID-19 Antigen (Colloidal Gold) e ile ea lekoa ho fihla ho 1.0×10⁵TCID50/mL ea SARS-CoV-2 e sa sebetseng mme ha ho phello ea hook e phahameng e bonoang.

Index of Symbol