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.


Lintlha tsa Sehlahisoa

Li-tag tsa Sehlahisoa

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

LIEKETSENG

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

Sebala 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 hlahella 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 thiti ena; 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

  1. SARS-CoV-2 Antigen Rapid Test Cassette ke ea ts'ebeliso ea litsebi tsa tlhahlobo ea in vitro feela. Teko e lokela ho sebelisoa ho fumana SARS-CoV-2 Antigen in Oropharyngeal Swab. Leha e le boleng ba bongata kapa sekhahla sa keketseho ea SARS- Khatiso ea CoV-2 e ka khethoa ke tlhahlobo ena ea boleng.
  2. 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.
  3. 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.
  4. Joalo ka liteko tsohle tsa tlhahlobo, liphetho tsohle li tlameha ho hlalosoa hammoho le lintlha tse ling tsa kliniki tse fumanehang ho ngaka.
  5. 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.
  6. Madi a mangata kapa mamina a papadi ya swab a ka sitisa tshebetso mme a ka hlahisa sephetho se fosahetseng.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.

 

 

 

 


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