SARS-CoV-2 Antigen Rapid Test Cassette
Tlhaloso e Khutšoanyane:
SARS-CoV-2 Antigen Rapid Test Cassette ke chromatographic immunoassay e potlakileng bakeng sa ho lemoha boleng ba antigen ea SARS-CoV-2 ho batho ba Oropharyngeal swabs. Boitsebiso bo ipapisitse le li-antibodies tse monoclonal tse khethehileng bakeng sa protheine ea Nucleocapsid (N) ea SARS- CoV-2. E reretsoe ho thusa ho fumana phapang e potlakileng ea ts'oaetso ea COVID-19.
TŠEBELETSO TŠEBELETSO
TheSARS-CoV-2 Antigen Rapid Test Cassetteke tlhahlobo e potlakileng ea chromatographic immunoassay bakeng sa ho lemoha boleng ba antigen ea SARS-CoV-2 ho batho ba Oropharyngeal swabs. Boitsebiso bo thehiloe holim'a li-antibodies tsa monoclonal tse khethehileng bakeng sa Protein ea Nucleocapsid (N) ea SARS-CoV-2. E reretsoe ho thusa ho lemoha phapang e potlakileng eaCOVID 19tšoaetso.
Litlhaloso tsa Sephutheloana
25 liteko / pakete, 50 liteko / pakete, 100 liteko / pakete
TS'ELISO
Li-coronaviruse tse ncha ke tsa mofuta oa β.COVID 19Hajoale, bakuli ba tšoaelitsoeng ke "coronavirus" ea morao-rao ke mohloli o ka sehloohong oa ts'oaetso; batho ba nang le tšoaetso ea asymptomatic le bona e ka ba mohloli oa tšoaetso. ho isa ho matsatsi a 14, haholo-holo 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.
REAGENTS
Khasete ea liteko e na le likaroloana tsa protheine ea anti-SARS-CoV-2 Nucleocapsid le anti-SARS-CoV-2 Nucleocapsid protheine e koahetsoeng ka lera.
MEHATO YA TLHOKOMELO
Ka kopo bala lintlha tsohle tse ka har'a sephutheloana sena pele u etsa tlhahlobo.
1. Bakeng sa ts'ebeliso ea tlhahlobo ea litsebi tsa in vitro feela. Se ke oa sebelisa kamora letsatsi la ho felloa ke nako.
2.Teko e lokela ho lula ka mokotleng o koetsoeng ho fihlela o loketse ho sebelisoa.
3.Mehlala eohle e lokela ho nkoa e le kotsi 'me e tšoaroe ka mokhoa o ts'oanang le moemeli oa tšoaetso.
4.Teko e sebelisitsoeng e lokela ho lahloa ho latela melao ea lehae.
5. Qoba ho sebelisa lisampole tse nang le mali.
6.Wear liatlana ha u fana ka lisampole, qoba ho ama lera la reagent le sampole hantle.
POLOKO LE TSAMAISO
Nako ea ho sebetsa ke likhoeli tse 18 haeba sehlahisoa sena se bolokiloe tikolohong ea
2-30℃. Teko e tsitsitse ka letsatsi la ho felloa ke nako e hatisitsoeng mokotleng o tiisitsoeng. Teko e tlameha ho lula ka mokotleng o tiisitsoeng ho fihlela o sebelisoa..U SE KE UA MAHAMISA.Se ke oa sebelisa ho feta letsatsi la ho felloa ke nako.
POKETSO LE TLASISO
1.Ho bokellana ha 'metso: Kenya sesepa se hloekisitsoeng 'metsong ka ho feletseng ho tloha molomong, bohareng ba lerako la 'metso le sebaka se khubelu sa lithane tsa mahalapa, hlakola lithane tse peli tsa pharyngeal le lebota le ka morao la pharyngeal ka mokhoa o itekanetseng.
matla, qoba ho ama leleme mme o ntshe letshwao.
2.Tlosa sampula hang-hang ka tharollo ea ho ntša mohlala e fanoeng ka har'a kit ka mor'a hore sampuli e bokelloe. Haeba e ke ke ea sebetsa hang-hang, sampole e lokela ho bolokoa ka har'a tube e ommeng, e hloekisitsoeng le e tiisitsoeng ka thata. E ka bolokoa ho 2-8 ℃ ka lihora tse 8, 'me e ka bolokoa nako e telele ho -70 ℃.
3. Mehlala e silafalitsoeng haholo ke mesaletsa ea lijo tse nooang e ke ke ea sebelisoa bakeng sa tlhahlobo ea sehlahisoa sena. Mehlala e bokelletsoeng ho li-swabs tse nang le viscous haholo kapa agglomerated ha e khothalletsoe bakeng sa tlhahlobo ea sehlahisoa sena. Haeba li-swabs li silafalitsoe ke mali a mangata, ha li khothalletsoe ho hlahlojoa. Ha ho khothalletsoe ho sebelisa lisampole tse sebetsitsoeng ka tharollo ea sampole ea ho ntšoa e sa fanoang ka har'a kit ena bakeng sa tlhahlobo ea sehlahisoa sena.
LIEKETSENG KOTLO
Lisebelisoa li fana ka
Likhasete tsa teko | Reagent ea ho ntša | Li-tubes tsa ho ntša | |
Li-Swabs tse nyopa | Tsenya Sephutheloana | Seteishene sa Mosebetsi |
Lisebelisoa tse hlokahalang empa ha li fane ka tsona
Sebali sa nako | Bakeng sa tšebeliso ea nako. |
Sephutheloana |
Litlhaloso25
liteko/pack50
liteko/pack100
liteko/packSample Extraction Reagent25 liteko/pack50 test/pack100 test/packSample extraction
tube≥25 tests/pack≥50 tests/pack≥100 tests/packInstructionRefer to the
packageSheba ho
packageSheba ho
sephutheloana
LITS'ELISO TŠEBELETSO
Lumella teko, mohlala, buffer ea ho ntša hore e lekane le mocheso oa kamore (15-30 ℃) pele ho tlhahlobo.
1.Tlosa k'hasete ea teko mokotleng o koetsoeng oa foil 'me u e sebelise nakong ea metsotso e 15. Liphetho tse ntle li tla fumanoa haeba tlhahlobo e etsoa hang ka mor'a ho bula mokotla oa foil.
2.Beha "Extraction Tube" sebakeng sa mosebetsi. Tšoara botlolo ea "extraction" ea "extraction" ka holimo ho ea holimo. Hlakola botlolo 'me u tlohelle tharollo eohle (Approx,250μL) e theohele ka har'a tube ea ho ntša ka bolokolohi ntle le ho ama bohale ba tube ho ea Extraction. Tube.
3.Beha mohlala oa swab ka har'a Extraction Tube.Phetoha ka sesepa ka metsotsoana e ka bang 10 ha u ntse u hatella hlooho ka hare ho tube ho lokolla antigen ka har'a swab.
4.Tlosa sesepa ha u ntse u petetsa hlooho ea swab khahlanong le ka hare ho Extraction Tube ha u ntse u e tlosa ho ntša metsi a mangata ka hohle kamoo ho ka khonehang etsa sesepa.
5.Tlohela ntlha ea dropper holim'a tube ea ho ntša.Beha k'hasete ea teko sebakeng se hloekileng le se lekaneng.
6.Eketsa marotholi a 2 a tharollo (hoo e ka bang, 65μL) ho sampuli hantle ebe o qala sebali sa nako.Bala sephetho se bontšitsoeng ka hare ho metsotso e 20-30, 'me liphetho tse baloang ka mor'a metsotso e 30 li fosahetse.
TLHALOSO LIPHETHO
KHABANE RESULT: |
Mohala o le mong oa mebala o hlaha sebakeng sa taolo (C). Ha ho na mohala o hlahang sebakeng sa tlhahlobo (T). Sephetho se seng se mpe se bontša hore antigen ea SARS-CoV-2 ha e eo setšoantšong, kapa e teng ka tlase ho boemo bo bonoang ba tlhahlobo.
KHABANERESULT:
Ho hlaha mela e mmedi.mola o le mong wa mmala o lokela ho ba sebakeng sa taolo (C) mme mola o mong o bonahalang o le mmala o lokela ho ba sebakeng sa teko (T).Sephetho se setle se bontsha hore SARS-CoV-2 e ile ya fumanwa mohlaleng oo.
LIPOLELO TSE FOSAHETSENG:
Taolo ea mohala e hloleha ho hlaha.Bophahamo bo sa lekaneng ba mohlala kapa mekhoa e fosahetseng ea mokhoa ke mabaka a ka bang mabaka a ho hloleha ha mohala oa taolo. Hlahloba mokhoa ona 'me u phete tlhahlobo ka tlhahlobo e ncha. Haeba bothata bo ntse bo tsoela pele, tlohela ho sebelisa lisebelisoa tsa tlhahlobo hang-hang 'me u ikopanye le mofani oa thepa ea sebakeng sa heno.
HLOKOMELA:
Botebo ba 'mala sebakeng sa liteko (T) bo tla fapana ho latela bongata ba SARS-CoV-2 Antigen bo teng mofuteng. Ka hona, moriti ofe kapa ofe oa 'mala sebakeng sa liteko (T) o lokela ho nkuoa o le ntle.
MOLAOLI KHABANE
- Taolo ea mekhoa e kenyelelitsoe tekong. Mohala o mebala-bala o hlahang sebakeng sa taolo (C) o nkoa e le taolo ea ka hare ea mekhoa.
- Litekanyetso tsa taolo ha li fanoe ka setsi sena; leha ho le jwalo, ho kgothaletswa hore ditaolo tse ntle le tse mpe di lekolwe e le mokgwa o motle wa laboratori ho netefatsa tshebetso ya teko le ho netefatsa tshebetso e nepahetseng ya teko.
LIEKETSENGLIEKETSENG TEKO
- TheSARS-CoV-2 Antigen Rapid Test Cassetteke bakeng sa ts'ebeliso ea tlhahlobo ea in vitro feela. Teko e lokela ho sebelisoa bakeng sa ho fumana SARS-CoV-2 Antigen in Oropharyngeal Swab. Ha ho boleng ba palo kapa sekhahla sa keketseho ea khatello ea SARS-CoV-2 e ka khethoa ke boleng bona. teko.
- Ho nepahala ha tlhahlobo ho ipapisitse le boleng ba sampole ea swab.Lintho tse fosahetseng tse fosahetseng li ka etsa hore ho be le polokelo ea sampole e sa lokelang.
- Khasete ea SARS-CoV-2 Antigen Rapid Test Cassette e tla bontša feela boteng ba SARS-CoV-2 ka har'a mohlala ho tsoa ho mefuta e sa sebetseng le e sa sebetseng ea SARS-CoV-2 coronavirus.
- Joalo ka liteko tsohle tsa tlhahlobo, liphetho tsohle li tlameha ho hlalosoa hammoho le lintlha tse ling tsa kliniki tse fumanehang ho ngaka.
- Sephetho se mpe se fumanoeng ho khithi ena se lokela ho netefatsoa ke PCR. Sephetho se seng se mpe se ka fumanoa haeba mohopolo oa SARS-CoV-2 o teng ka har'a swab o sa lekana kapa o le ka tlase ho boemo bo bonoang ba tlhahlobo.
- Madi a mangata kapa mamina a papadi ya swab a ka sitisa tshebetso mme a ka hlahisa sephetho se fosahetseng.
- Sephetho se setle bakeng sa SARS-CoV-2 ha se thibele tšoaetso e teng le anther pathogen. Ka hona, ho lokela ho nahanoa ka monyetla oa ho ba le tšoaetso ea baktheria.
- Liphetho tse mpe ha li ahlole tšoaetso ea SARS-CoV-2, haholo-holo ho ba kileng ba kopana le vaerase. Teko ea ho latela ka tlhahlobo ea limolek'hule e lokela ho nkoa e le ho thibela tšoaetso ho batho bana.
- Liphetho tse ntle e kanna ea ba ka lebaka la ts'oaetso ea li-coronavirus tse seng tsa SARS-CoV-2, joalo ka coronavirus HKU1, NL63, OC43, kapa 229E.
- Liphetho tsa tlhahlobo ea antigen ha lia lokela ho sebelisoa e le eona feela motheo oa ho hlahloba kapa ho qhelela ka thoko tšoaetso ea SARS-CoV-2 kapa ho tsebisa boemo ba ts'oaetso.
- Extraction reagent e na le matla a ho bolaea kokoana-hloko, empa e ke ke ea tima 100% ea kokoana-hloko.Mokhoa oa ho thibela kokoana-hloko o ka boleloa: ke mokhoa ofe o khothalletsoang ke WHO / CDC, kapa o ka sebetsanoa ho latela melao ea sebaka seo.
LIEKETSENG TS'EBETSO
Kutloelo-bohlokoleTse khethehileng
SARS-CoV-2 Antigen Rapid Test Cassette e hlahlobiloe ka mehlala e fumanoeng ho bakuli.PCR e sebelisoa e le mokhoa oa litšupiso bakeng sa Cassette ea Tlhahlobo e Potlakileng ea SARS-CoV-2. Mehlala e ile ea nkoa e le ntle haeba PCR e bontšitse sephetho se nepahetseng.
Mokhoa | RT-PCR | Kakaretso ea Liphetho | ||
SARS-CoV-2 Antigen Rapid Test Cassette | Liphetho | E ntle | E mpe | |
E ntle | 38 | 3 | 41 | |
E mpe | 2 | 360 | 362 | |
Kakaretso ea Liphetho | 40 | 363 | 403 |
Boikutlo bo Lekanyelitsoeng :95.0%(95%CI*:83.1%-99.4%)
Litlhaloso Tse Batlang:99.2%(95%CI*:97.6%-99.8%)
*Linako tsa ho itšepa
Moeli oa ho Khetholla
Ha litaba tsa vaerase li le kholo ho feta 400TCID50/ml, sekhahla sa ho lemoha se nepahetseng se feta 95%. Ha litaba tsa vaerase li le ka tlase ho 200TCID50/ml, sekhahla sa ho lemoha se nepahetseng se ka tlase ho 95%, kahoo moeli o tlase oa ho fumanoa oa sehlahisoa sena ke 400TCID.50/ml.
Nepahalo
Lihlopha tse tharo tse latellanang tsa li-reagents li ile tsa lekoa bakeng sa ho nepahala. Li-batches tse fapaneng tsa li-reagents li ile tsa sebelisoa ho leka sampole e le 'ngoe e mpe ka makhetlo a 10 ka tatellano,' me liphetho kaofela li ne li le mpe. Ho ile ha sebelisoa lihlopha tse fapaneng tsa li-reagents ho leka sampole e tšoanang makhetlo a 10 ka tatellano, 'me liphetho kaofela li ne li le ntle.
phello ea HOOK
Ha litaba tsa vaerase sampuling e lokelang ho hlahlojoa li fihla ho 4.0*105TCID50/ml, sephetho sa tlhahlobo se ntse se sa bontše phello ea HOOK.
Cross-Reactivity
Cross-reactivity of the Kit e ile ea hlahlojoa. Liphetho li bonts'itse ha ho reactivity e fapaneng ka mohlala o latelang.
Lebitso | Ho tsepamisa maikutlo |
HCOV-HKU1 | 105TCID50/ml |
Staphylococcus aureus | 106TCID50/ml |
Sehlopha sa A streptococci | 106TCID50/ml |
Kokoana-hloko ea 'maselese | 105TCID50/ml |
Kokoana-hloko ea mumps | 105TCID50/ml |
Mofuta oa 3 oa Adenovirus | 105TCID50/ml |
Mycoplasmal pneumonia | 106TCID50/ml |
Paraimfluenzavirus, mofuta oa 2 | 105TCID50/ml |
Metapneumovirus ea motho | 105TCID50/ml |
Coronavirus ea batho OC43 | 105TCID50/ml |
Coronavirus ea batho 229E | 105TCID50/ml |
Bordetella parapertusis | 106TCID50/ml |
Lefuba la B Victoria TŠEBELETSO | 105TCID50/ml |
Influenza B YSTRAIN | 105TCID50/ml |
Influenza A H1N1 2009 | 105TCID50/ml |
Influenza A H3N2 | 105TCID50/ml |
H7N9 | 105TCID50/ml |
H5N1 | 105TCID50/ml |
Epstein-Barr kokoana-hloko | 105TCID50/ml |
Enterovirus CA16 | 105TCID50/ml |
Rhinovirus | 105TCID50/ml |
Vaerase ya phefumoloho ya matshwafo | 105TCID50/ml |
Streptococcus pneumoni-ae | 106TCID50/ml |
Candida albicans | 106TCID50/ml |
Chlamydia pneumoniae | 106TCID50/ml |
Bordetella pertussis | 106TCID50/ml |
Pneumocystis jiroveci | 106TCID50/ml |
Mycobacterium lefuba | 106TCID50/ml |
Legionella pneumophila | 106TCID50/ml |
Iho kena-kenana le Lintho
Liphetho tsa liteko ha li na ho kena-kenana le ntho eo maemong a latelang:
Ho kena-kenana ntho | Conc. | Ntho e sitisang | Conc. |
Madi Kaofela | 4% | Motsoako oa Benzoin Gel | 1.5mg/ml |
Ibuprofen | 1mg/ml | Cromolyn glycate | 15% |
tetracycline | 3ug/ml | chloramphenicol | 3ug/ml |
Mucin | 0.5% | Mupirocin | 10mg/ml |
Erythromycin | 3ug/ml | Oseltamivir | 5mg/ml |
Tobramycin | 5% | Naphazoline Hydrochlor-ride Nasal Drops | 15% |
menthol | 15% | Fluticasone propionate spray | 15% |
Afrin | 15% | Deoxyepinephrine hydrochloride | 15% |
BIBLIOGRAFI
1.Weiss SR, Leibowitz JZ.Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164
2.Cui J,Li F,Shi ZL.Tshimoloho le ho iphetola ha likokoana-hloko tsa pathogenic coronaviruses.Nat Rev Microbiol 2019;17:181-192.
3.Su S,Wong G,Shi W,et al.Epidemiology, recombination ea lefutso, le pathogenesis ea coronaviruses. TrendsMicrobiol 2016; 24:490-502.