Khasete ea Tlhahlobo e Potlako ea COVID-19 Antigen (Colloidal Gold)
[SEBELISA TŠEBELETSO]
The COVID-19 Antigen Rapid Test Cassette (Saliva) ke lateral flow immunoassay e reretsoeng ho lemoha boleng ba SARS-CoV-2 nucleocapsid antigens ka mathe ho tsoa ho batho bao ho belaelloang hore ba na le COVID-19 ke mofani oa bona oa tlhokomelo ea bophelo.
Liphetho ke tsa ho tsebahatsa SARS-CoV-2 nucleocapsid antigen.Antigen hangata e bonoa mathe nakong ea ts'oaetso e matla.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.
Khasete ea Teko e Potlakileng ea COVID-19 (Mathe) e reretsoe ho sebelisoa ke litsebi tsa bongaka kapa basebetsi ba koetlisitsoeng ba nang le litsebo tsa ho etsa liteko tsa lateral flow.Sehlahisoa se ka sebelisoa tikolohong efe kapa efe ea laboratori le eo eseng ea laboratoring e fihlelang litlhoko tse boletsoeng ho Litaelo tsa Tšebeliso le melaoana ea lehae.
[KAKARETSO]
Novel coronaviruses (SARS-CoV-2) ke ea mofuta oa p.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.
[MOLAO-MOTHEO]
The COVID-19 Antigen Rapid Test Cassette (Saliva) ke lateral flow immunoassay e ipapisitseng le 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 liteko, moo o tla ts'oaroa ke SARS-CoV-2 nucleocapsid protheine monoclonal antibody.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.
[TEMOHELO LE MEKELO]
• Bakeng sa tšebeliso ea in vitro diagnostic feela.
• Bakeng sa litsebi tsa bophelo bo botle le batho ka bomong ba koetlisitsoeng libakeng tsa tlhokomelo.
•Se ke oa sebelisa sehlahisoa sena e le eona feela motheo oa ho hlahloba kapa ho se kenyelletsa
Tšoaetso ea SARS-CoV-2 kapa ho tsebisa boemo ba tšoaetso ea COVID-19.
•Se ke oa sebelisa sehlahisoa sena kamora letsatsi la ho felloa ke nako.
•Ka kopo bala lintlha tsohle tse pampitšaneng ena pele u etsa tlhahlobo.
•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.
•Khasete ea teko e sebelisitsoeng e lokela ho lahloa ho latela melao ea mmuso, ea naha le ea lehae.
[Tlhaloso]
Thepa e Fanoeng
•Likhasete tsa Teko: k'hasete ka 'ngoe e nang le desiccant ka mokotleng o mong oa foil
• Lisebelisoa tsa ho ntša: ampoule e nang le 0.3 mL ea reagent ea ho ntša
•Babokelli ba mathe
• Li-tubes tsa pokello
•Lirotholi
•Pakete Kenya
Lintho Tse Hlokehang Empa li sa Fanoe
•Sebala nako
[POLOKO LE BOTSITSO]
• Boloka ka mokhoa o phuthetsoeng ka mokotleng o koetsoeng ka mocheso (4-30°C kapa 40-86T).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.
•Lotho le letsatsi la ho felloa ke nako li ngotsoe holim'a leibole.
[KOKELO LE BOITLHAKISO TSA MEKOLO]
U SE KE UA kenya letho ka hanong ho kenyelletsa lijo, lino, chepisi kapa lihlahisoa tsa koae bonyane metsotso e 30 pele u bokelloa.
Sebelisa li-tube tsa pokello le pokello ea mathe ho bokella mathe.Kenya ntho e bokellang mathe ka har'a tšupu ea pokello, ebe u beha pokello ea mathe haufi le molomo 'me u lumelle mathe ho phalla ka har'a tube ea pokello.Bophahamo ba mathe bo lokela ho ba sekala (approx.300|jL).Haeba molumo oa mathe o le ngata haholo, sebelisa dropper ho tlosa mathe a feteletseng ho fihlela tharollo ea ho qetela letšoao la sekala (hoo e ka bang 300pL).[SEBELISA TŠEBELETSO]
The COVID-19 Antigen Rapid Test Cassette (Saliva) ke lateral flow immunoassay e reretsoeng ho lemoha boleng ba SARS-CoV-2 nucleocapsid antigens ka mathe ho tsoa ho batho bao ho belaelloang hore ba na le COVID-19 ke mofani oa bona oa tlhokomelo ea bophelo.
Liphetho ke tsa ho tsebahatsa SARS-CoV-2 nucleocapsid antigen.Antigen hangata e bonoa mathe nakong ea ts'oaetso e matla.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.
Khasete ea Teko e Potlakileng ea COVID-19 (Mathe) e reretsoe ho sebelisoa ke litsebi tsa bongaka kapa basebetsi ba koetlisitsoeng ba nang le litsebo tsa ho etsa liteko tsa lateral flow.Sehlahisoa se ka sebelisoa tikolohong efe kapa efe ea laboratori le eo eseng ea laboratoring e fihlelang litlhoko tse boletsoeng ho Litaelo tsa Tšebeliso le melaoana ea lehae.
[KAKARETSO]
Novel coronaviruses (SARS-CoV-2) ke ea mofuta oa p.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.
[MOLAO-MOTHEO]
The COVID-19 Antigen Rapid Test Cassette (Saliva) ke lateral flow immunoassay e ipapisitseng le 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 liteko, moo o tla ts'oaroa ke SARS-CoV-2 nucleocapsid protheine monoclonal antibody.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.
[TEMOHELO LE MEKELO]
• Bakeng sa tšebeliso ea in vitro diagnostic feela.
• Bakeng sa litsebi tsa bophelo bo botle le batho ka bomong ba koetlisitsoeng libakeng tsa tlhokomelo.
•Se ke oa sebelisa sehlahisoa sena e le eona feela motheo oa ho hlahloba kapa ho se kenyelletsa
Tšoaetso ea SARS-CoV-2 kapa ho tsebisa boemo ba tšoaetso ea COVID-19.
•Se ke oa sebelisa sehlahisoa sena kamora letsatsi la ho felloa ke nako.
•Ka kopo bala lintlha tsohle tse pampitšaneng ena pele u etsa tlhahlobo.
•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.
•Khasete ea teko e sebelisitsoeng e lokela ho lahloa ho latela melao ea mmuso, ea naha le ea lehae.
[Tlhaloso]
Thepa e Fanoeng
•Likhasete tsa Teko: k'hasete ka 'ngoe e nang le desiccant ka mokotleng o mong oa foil
• Lisebelisoa tsa ho ntša: ampoule e nang le 0.3 mL ea reagent ea ho ntša
•Babokelli ba mathe
• Li-tubes tsa pokello
•Lirotholi
•Pakete Kenya
Lintho Tse Hlokehang Empa li sa Fanoe
•Sebala nako
[POLOKO LE BOTSITSO]
• Boloka ka mokhoa o phuthetsoeng ka mokotleng o koetsoeng ka mocheso (4-30°C kapa 40-86T).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.
•Lotho le letsatsi la ho felloa ke nako li ngotsoe holim'a leibole.
[KOKELO LE BOITLHAKISO TSA MEKOLO]
U SE KE UA kenya letho ka hanong ho kenyelletsa lijo, lino, chepisi kapa lihlahisoa tsa koae bonyane metsotso e 30 pele u bokelloa.
Sebelisa li-tube tsa pokello le pokello ea mathe ho bokella mathe.Kenya ntho e bokellang mathe ka har'a tšupu ea pokello, ebe u beha pokello ea mathe haufi le molomo 'me u lumelle mathe ho phalla ka har'a tube ea pokello.Bophahamo ba mathe bo lokela ho ba sekala (approx.300|jL).Haeba molumo oa mathe o le ngata haholo, sebelisa dropper ho tlosa mathe a feteletseng ho fihlela tharollo ea ho qetela letšoao la sekala (hoo e ka bang 300pL).
Mohlala oa Lipalangoang le Polokelo
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.
[TEKA TS'EBETSO]
Tlhokomeliso: Lumella lik'hasete tsa teko, li-reagents le mehlala ho lumellana le mocheso oa kamore (15-30 ° C kapa 59-86T) pele ho teko.
Beha tšupu ea pokello e nang le mathe a nang le mathe sebakeng sa mosebetsi.Tlosa sekwahelo sa reagent ea ho ntša.Kenya li-reagents tsohle tsa ho ntša ka har'a tube ea pokello.
Lahla motho ea bokellang mathe;Koahela tšupu ea pokello ka ntlha ea marotholi holim'a tube ea pokello.Hlakola tube ea pokello ka makhetlo a fetang a mararo ka matla ho kopanya mathe le reagent ea ho ntša, ebe o hatella tharollo e tsoakiloeng ka makhetlo a leshome ho lumella mathe hore a kopane ka ho feletseng.
Tlosa k'hasete ea teko ka mokotleng o koetsoeng.
Khutlisetsa tšupu ea pokello, u tšoere tube e otlolohile, fetisetsa marotholi a 3 (hoo e ka bang 100pL) butle-butle ho ea ho mohlala oa seliba (S) sa k'hasete ea teko, ebe u qala sebali sa nako.
Emela hore mela e mebala e hlahe.Hlalosa liphetho tsa liteko ka metsotso e 15.Se ke oa bala liphetho kamora metsotso e 20.
| [TOTOLLO EA LIPOTSO] | |||
| E ntle | | § | Ho hlaha mela e mmedi.Mohala o le mong oa mebala o hlaha H c sebakeng sa taolo (C), 'me o mong oa mebala oa Jt|jne e hlaha sebakeng sa teko (T), ho sa tsotelehe matla a mohala oa teko. | |
| E mpe | Mohala o le mong oa mebala o hlaha sebakeng sa taolo (C), 'me ha ho na mohala o hlahang sebakeng sa teko (T). | ||
| Ha e sebetse | Control line hloleha ho hlaha.E sa lekaneng,mohlala oa bophahamo ba modumo kapa mekhoa e fosahetseng ea mekhoa ea 5 ke mabaka a ka 'nang a etsahala a ho hlōleha ha mohala oa ho laola.Hlahloba mokhoa ona le Jtpheta teko ka ho sebelisa k'hasete e ncha ea teko.HaebaJ)bothata bo ntse bo tsoela pele, khaotsa ho sebelisa lotho hang-hang 'me u ikopanye le mofani oa thepa ea sebakeng sa heno. | ||
[QUALITY LAOLI]
Taolo ea mekhoa e kenyelelitsoe tekong.Mohala o mebala o hlahang sebakeng sa taolo (C) o nkoa e le taolo ea ka hare ea tsamaiso.E tiisa molumo o lekaneng oa mohlala, ho koala lera le lekaneng le mokhoa o nepahetseng oa mokhoa.
Tekanyetso ea taolo ha e fanoe le khithi ena.Leha ho le joalo, ho khothaletsoa hore litsamaiso tse nepahetseng le tse mpe li lekoe e le tloaelo e ntle ea laboratori ho netefatsa mokhoa oa tlhahlobo le ho netefatsa ts'ebetso e nepahetseng ea tlhahlobo.
[MELAO]
Sehlahisoa se lekanyelitsoe ho fana ka tlhahlobo ea boleng.Boima ba mohala oa teko ha bo hlile ha bo amane le bongata ba antigen ea mehlala.
Liphetho tse mpe ha li thibele tšoaetso ea SARS-CoV-2 mme ha ea lokela ho sebelisoa e le eona feela motheo oa liqeto tsa taolo ea mokuli.
Ngaka e tlameha ho hlalosa liphetho hammoho le histori ea mokuli, liphuputso tsa 'mele le mekhoa e meng ea ho hlahloba.
Sephetho se mpe se ka hlaha haeba palo ea li-antigen tsa SARS-CoV-2 tse teng mohlaleng li le ka tlase ho moeli oa tlhahlobo, kapa vaerase e bile le liphetoho tse nyane tsa amino acid sebakeng sa epitope se lemohuoang ke li-antibodies tsa monoclonal. e sebelisitsoeng tekong.
[DITLHAKISO TSA SEBETSI]
Ts'ebetso ea Clinical
Ts'ebetso ea bongaka ea COVID-19 Antigen Rapid Test Cassette (Saliva) e thehiloe lithutong tse tlang ho bokelloa ho tsoa ho bakuli ba nang le matšoao a 628 (matsatsing a 7 ho tloha qalong) le bakuli ba se nang matšoao ba neng ba belaelloa ka COVID-19.
Kakaretso ea lintlha tsa Teko e potlakileng ea COVID-19 Antigen ka tlase:
Moeli oa potoloho ea RT-PCR (Ct) ke boleng bo loketseng ba lets'oao.Theko e tlaase ea Ct e bontša bongata ba kokoana-hloko e phahameng.Kutloisiso e ne e baloa bakeng sa mefuta e fapaneng ea boleng ba Ct (Ct valueW37)
| Antfgeno COVID-19 | RT-PCR | Kakaretso | ||
| Positivo | Negativo | |||
| HEO® | Positivo | 172 | 0 | 172 |
| Negativo | 3 | 453 | 456 | |
| Kakaretso | 175 | 453 | 628 | |
Positive Percent Agreement(PPA)=98.28%(172/175),(95%CI:95.08%~99.41%)
Negative Percent Agreement(NPA)=100%(453/453),(95%CI:99.15%~100%)
PPA - Tumellano e Positive Peresente (Boikutlo)
NPA - Tumellano e Negative Peresente (Tlhahiso)
Moeli oa ho Lemoha (Boikutlo ba Analytical)
Boithuto bona bo sebelisitse kokoana-hloko ea SARS-CoV-2 (Isolate Hong Kong/ VM20001061/2020, NR-52282), e sa sebetseng mocheso 'me e tšeloa ka mathe.Moeli oa ho Lemoha (LoD) ke 8.6 X102TCIDso/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 molomong oa molomo.
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 na cross-reactivity e ileng ea bonoa ka livaerase tse latelang ha li ne li lekoa ka bongata ba 1.0x106PFU/mL: Influenza A (H1N1), Influenza A
(H1N1 pdm09), Influenza A(H3N2), Influenza B(Yamagata), Influenza B(Victoria), Adenovirus (mofuta 1, 2, 3, 5, 7, 55), Human metapneumovirus, Parainfluenza virus (mofuta oa 1,2, 3, 4), kokoana-hloko ea ho hema ea syncytial, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.
Ha ho cross-reactivity e ileng ea hlokomeloa ka libaktheria tse latelang ha li lekoa ka bongata ba 1.0x10' CFU/mL: Mycoplasma pneumoniae, Chlamy dia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (sehlopha sa A), Streptococcus pneumoniae, Candida al. aureus.
Tšitiso
Lintho tse latelang tse ka bang teng tsa tšitiso li hlahlobiloe ka Khasete ea Tlhahlobo e Potlakileng ea COVID-19 (Mathe) maemong a thathamisitsoeng ka tlase 'me ho fumanoe hore ha e ame ts'ebetso ea tegt.
| Ntho | Ho tsepamisa maikutlo | Ntho | Ho tsepamisa maikutlo |
| Mucin | 2% | Madi kaofela | 4% |
| Benzocaine | 5 mg/mL | Menthol | 10 mg / mL |
| Saline nasal spray | 15% | Phenylephrine | 15% |
| Oxymetazoline | 15% | Histamine dihydrochloride | 10 mg / mL |
| Tobramycin | 5 pg/mL | Mupirocin | 10 mg / mL |
| Oseltamivir phosphate | 10 mg / mL | Zanamivir | 5 mg/mL |
| Arbidol | 5 mg/mL | Ribavirin | 5 mg/mL |
| Fluticasone propionate | 5% | Dexamethasone | 5 mg/mL |
| Triamcinolone | 10 mg / mL |
Hook Effect ea tekanyo e phahameng
The COVID-19 Antigen Rapid Test Cassette (Saliva) e ile ea lekoa ho fihla ho 1.15x1 o' TCIDso/mL ea SARS-CoV-2 e sa sebetseng 'me ha ho phello ea hook e phahameng e ileng ea bonoa.
Hangzhou Heo Technology Co., Ltd.
Aterese:Room201, Building3, No.2073 Jinchang Road,
Seterata sa Liangzhu, Setereke sa Yuhang, Hangzhou, China Postcode:311113
Mohala:0086-571-87352763 E-mail:52558565@qq.com
Aterese ea Lotus NL BV:Koningin Julianaplein 10, le Verd,
2595AA, The Hague, Netherlands.E-mail:Peter@lotusnl.com
Mohala:+31644168999
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.
TLHALOSO LIPHETHO
| E ntle | C T | C T | Ho hlaha mela e mmedi.Mohala o le mong oa mebala o hlaha oa matla a mohala oa teko. |
| E mpe | CT | Mohala o le mong oa mebala o hlaha sebakeng sa taolo (C), 'me ha ho na mohala o hlahang sebakeng sa teko (T). | |
| Ha e sebetse | C T | CT | Taolo mola hloleha to hlaha. Bophahamo bo sa lekaneng ba mohlala kapa mekhoa e fosahetseng ea tsamaiso ke mabaka a ka 'nang a baka ho hloleha ha mohala oa taolo.Hlahloba mokhoa ona 'me u phete tlhahlobo u sebelisa k'hasete e ncha ea teko.Haeba bothata bo ntse bo tsoela pele, tlohela ho sebelisa lotho hang-hang 'me u ikopanye le mofani oa thepa ea sebakeng sa heno. |
MOLAOLI KHABANE
Taolo ea mekhoa e kenyelelitsoe tekong.Mohala o mebala o hlahang sebakeng sa taolo (C) o nkoa e le taolo ea ka hare ea tsamaiso.E tiisa molumo o lekaneng oa mohlala, ho koala lera le lekaneng le mokhoa o nepahetseng oa mokhoa.
Tekanyetso ea taolo ha e fanoe le khithi ena.Leha ho le joalo, ho khothaletsoa hore litsamaiso tse nepahetseng le tse mpe li lekoe e le tloaelo e ntle ea laboratori ho netefatsa mokhoa oa tlhahlobo le ho netefatsa ts'ebetso e nepahetseng ea tlhahlobo.
LIEKETSENG
•Sehlahisoa se lekanyelitsoe ho fana ka tlhahlobo ea boleng.Boima ba mohala oa teko ha bo hlile ha bo amane le bongata ba antigen ea mehlala.
•Liphetho tse mpe ha li thibele tšoaetso ea SARS-CoV-2 mme haeba matšoao a teng u tlameha ho batla tlhahlobo e eketsehileng hanghang Ka Mokhoa oa PCR.
•Ngaka e tlameha ho hlalosa liphetho hammoho le nalane ea mokuli, liphuputso tsa 'mele, le mekhoa e meng ea tlhahlobo.
•Sephetho se mpe se fumanoeng ho Kit ena se lokela ho netefatsoa ke PCR.Sephetho se mpe se ka hlaha haeba palo ea li-antigen tsa SARS-CoV-2 tse teng mohlaleng li le ka tlase ho moeli oa tlhahlobo, kapa vaerase e bile le liphetoho tse nyane tsa amino acid sebakeng sa epitope se lemohuoang ke li-antibodies tsa monoclonal. e sebelisitsoeng tekong.
•Madi a mangata kapa mamina a sesepa a ka sitisa tshebetso mme a hlahisa sephetho se fosahetseng.
LIEKETSENG TS'EBETSO
Ts'ebetso ea Clinical
Taolo ea mekhoa e kenyelelitsoe tekong.Mohala o mebala o hlahang sebakeng sa taolo (C) o nkoa e le taolo ea ka hare ea tsamaiso.E tiisa molumo o lekaneng oa mohlala, ho koala lera le lekaneng le mokhoa o nepahetseng oa mokhoa.
Tekanyetso ea taolo ha e fanoe le khithi ena.Leha ho le joalo, ho khothaletsoa hore litsamaiso tse nepahetseng le tse mpe li lekoe e le tloaelo e ntle ea laboratori ho netefatsa mokhoa oa tlhahlobo le ho netefatsa ts'ebetso e nepahetseng ea tlhahlobo.
| COVID-19 antigen | RT-PCR | Totale | ||
| E ntle | E mpe | |||
| HEO® | E ntle | 212 | 0 | 212 |
| E mpe | 3 | 569 | 572 | |
| Kakaretso | 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% *Linako tsa ho itšepa
| Matsatsi ho tloha matšoao | RT-PCR | HEO THEKNOLOJI | Tumellano(%) |
| 0-3 | 95 | 92 | 96.84% |
| 4-7 | 120 | 120 | 100% |
| CT Boleng | RT-PCR | HEO THEKNOLOJI | Tumellano(%) |
| Ct≤30 | 42 | 42 | 100% |
| Ct≤32 | 78 | 78 | 100% |
| Ct≤35 | 86 | 85 | 98.84% |
| ＜37 | 9 | 7 | 77.78% |
Moeli oa ho Lemoha (Boikutlo ba Analytical)
Boithuto bona bo sebelisitse kokoana-hloko ea SARS-CoV-2 e hlabollang, e sa sebetseng mocheso 'me e tšeloa ka har'a mohlala oa swab ea nko.Moeli oa ho Fumana (LoD) ke 1.0 ×102 TCID50/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 hlokomeloa ka likokoana-hloko tse latelang ha li ne li lekoa ka bongata ba 1.0×106 PFU/mL: Influenza A (H1N1), Influenza A (H1N1pdm09), Influenza A (H7N9), 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 na 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, albicans 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.
| Ntho | Ho tsepamisa maikutlo | Ntho | Ho tsepamisa maikutlo |
| Mucin | 2% | Madi kaofela | 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 |
Hook Effect ea tekanyo e phahameng
The COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) e ile ea lekoa ho fihla ho 1.0×10 5 TCID50 /mL ea inactivated SARS-CoV-2 mme ha ho na phello ea hook e phahameng e bonoang.
Potso e Botsoang Khafetsa
1.Teko ea SARS-CoV-2 Antigen Rapid Test e sebetsa joang?Teko ke ea tlhahlobo ea boleng ba li-antigen tsa SARS-CoV-2 mefuteng e iketselitsoeng ea swab.Sephetho se setle se bonts'a li-antigen tsa SARS-CoV-2 tse teng setšoantšong.
Teko e lokela ho sebelisoa neng?
SARS-CoV-2 antigen e ka bonoa ts'oaetso e matla ea phefumoloho, ho kgothaletswa ho etsa tlhahlobo ha matšoao a kenyelletsa ho qala ka tšohanyetso bonyane e 'ngoe ea tse latelang: ho khohlela, feberu, ho hema ka thata, mokhathala, ho fokotseha ha takatso ea lijo, myalgia.
Na sephetho e ka ba se fosahetseng?
Liphetho li nepahetse ho fihlela litaelo li hlomphuoa ka hloko.Leha ho le joalo, sephetho se ka fosahala haeba bophahamo ba lisampole bo sa lekaneng kapa tlhahlobo e potlakileng ea SARS-CoV-2 Antigen Rapid e koloba pele e etsoa tlhahlobo, kapa haeba palo ea marotholi a "buffer" a le ka tlase ho 3 kapa ho feta 4. Ntle le moo, ka lebaka la melao-motheo ea immunology. e amehang, ho na le menyetla ea ho ba le liphello tse fosahetseng maemong a sa tloaelehang.Kamehla ho kgothaletswa ho buisana le ngaka bakeng sa liteko tse joalo tse thehiloeng ho melao-motheo ea immunology.
Joang ho hlalosa teko haeba 'mala le matla a mela li fapane?Mmala le matla a mela ha a na bohlokoa bakeng sa tlhaloso ea sephetho.Methapo e lokela ho ba homogeneous le ho bonahala ka ho hlaka.Teko e lokela ho nkoa e le ntle ho sa tsotellehe hore na matla a 'mala oa mohala oa teko ke ofe.5.Ke lokela ho etsa eng haeba sephetho se le mpe?
Sephetho se se nang leeme se bolela hore ha u eo kapa hore bongata ba kokoana-hloko bo tlase haholo
ho tsejwa ke teko.Leha ho le joalo, hoa khonahala hore tlhahlobo ena e fane ka sephetho se fosahetseng se fosahetseng (e fosahetseng) ho batho ba bang ba nang le COVID-19.Sena se bolela hore o kanna oa ba le COVID-19 leha tlhahlobo e le ntle.
Haeba u e-na le matšoao a kang hlooho, migraine, feberu, ho lahleheloa ke monko le tatso, ikopanye le setsi sa bongaka se haufi u sebelisa melao ea bolaoli ba sebaka sa heno.Ho feta moo, o ka pheta tlhahlobo ka lisebelisoa tse ncha tsa tlhahlobo.Haeba ho na le lipelaelo, pheta tlhahlobo kamora matsatsi a 1-2, kaha coronavirus e ke ke ea bonoa ka nepo likarolong tsohle tsa ts'oaetso.Melao ea sebaka le bohloeki e ntse e tlameha ho hlokomeloa.Leha ho ka ba le sephetho se fosahetseng sa tlhahlobo, melao ea sebaka le bohloeki e tlameha ho hlokomeloa, ho falla/ho eta, ho ea liketsahalong joalo-joalo li lokela ho latela litataiso/litlhoko tsa lehae tsa COVID.6.Ke lokela ho etsa eng haeba sephetho se le ntle?
Sephetho se setle se bolela boteng ba li-antigen tsa SARS-CoV-2.Liphetho tse ntle li bolela hore ho ka etsahala hore ebe u na le COVID-19.E-ea ho itšehla thajana hang-hang ho latela litataiso tsa lehae 'me hang-hang ikopanye le ngaka / ngaka ea hau kapa lefapha la bophelo bo botle ba lehae ho latela litaelo tsa ba boholong sebakeng sa heno.Sephetho sa tlhahlobo ea hau se tla hlahlojoa ke tlhahlobo ea netefatso ea PCR 'me u tla hlalosetsoa mehato e latelang.
BIBLIOGRAFIE
Weiss SR, Leibowitz JZ.Coronavirus pathogensis, Adv Virus Res 2011;81:85-164
Cui J, li F, Shi ZL.Tšimoloho le tsoelo-pele ea li-coronavirus tsa pathogenic.Nat Rev Microbiol 2019; 17:181-192
Su S,Wong G, Shi W, et al.Epidemiology, genetic recombination, le pathogenesis ea coronaviruses.TrendsMicrobiol 2016;24:4900502.
LINTLHA TSA MATSOSO
