COVID-19 Anti-2019-nCoV China Coronavirus e Ncha

Lintlha tse Potlakileng

COVID-19 Anti-2019-nCoV China Coronavirus e Ncha

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Litlhaloso

[SEBELISA TŠEBELETSO]
AMRDT100 IgG/IgM Rapid Test Cassette ke lateral flow chromatographic immunoassay bakeng sa phumano ea boleng ba li-antibodies (IgG le IgM) ho Novel coronavirus in Human Whole Blood/Serum/Plasma.
E fana ka thuso ho hlahlobeng tšoaetso ea Novel coronavirus.

[KAKARETSO]
Mathoasong a Pherekhong 2020, "coronavirus" ea nalane (SARS-CoV-2, eo pele e neng e tsejoa e le 2019-nCoV) e ile ea tsejoa e le moemeli oa tšoaetso e bakang ho phatloha ha pneumonia ea vaerase Wuhan, China, moo linyeoe tsa pele li ileng tsa qala ho ba le matšoao ka December 2019.
Coronaviruses ke livaerase tse aparetsoeng ke RNA tse ajoang ka bophara har'a batho, liphoofolo tse ling tse anyesang le linonyana 'me li baka mafu a ho hema, a enteric, hepatic le neurologic.Mefuta e tšeletseng ea coronavirus e tsejoa e baka lefu la batho.Livaerase tse 'ne-229E, OC43, NL63, le HKU1 li atile mme hangata li baka matšoao a batang a tloaelehileng ho batho ba sa tsebeng ho itšireletsa mafung.Likokoana-hloko tse ling tse peli tse matla a hlobaetsang le ho hema ha coronavirus (SARS-CoV) le Middle East Respiratory Syndrome (MERS-CoV) li tsoa ho zoonotic mme ka linako tse ling li amahanngoa le bokuli bo bolaeang.
Coronaviruses ke zoonotic, ho bolelang hore li fetisoa lipakeng tsa liphoofolo le batho.Matšoao a tloaelehileng a tšoaetso a kenyelletsa matšoao a ho hema, feberu, ho khohlela, ho hema ka thata le bothata ba ho hema.Maemong a matla le ho feta, tšoaetso e ka baka pneumonia, lefu le matla la ho hema, ho hloleha ha liphio esita le lefu.
Litlhahiso tse tloaelehileng tsa ho thibela ho ata ha tšoaetso li kenyelletsa ho hlatsoa matsoho khafetsa, ho koala molomo le nko ha u khohlela le ho thimola, ho pheha nama le mahe ka botlalo.Qoba ho kopana haufi le mang kapa mang ea nang le matšoao a lefu la ho hema joalo ka ho khohlela le ho thimola.

[MOLAO-MOTHEO]
AMRDT100IgG/IgM Rapid Test Cassette ke tlhahlobo ea boleng ea membrane e thehiloeng ho immunoassay bakeng sa ho lemoha li-antibodies (IgG le IgM) ho Novel coronavirus maling a Motho a Felletseng/Serum/Plasma.K'hasete ea liteko e na le: 1) "burgundy cojugate pad" e nang le "Novel coronavirus recombinant envelope antigens" e kopantsoeng le Colloid gold (Novel coronavirus conjugates), 2) lesela la nitrocellulose le nang le mela e 'meli ea liteko (mela ea IgG le IgM) le mohala oa taolo ( C mola).Mohala oa IgM o entsoe esale pele ka anti-Human IgM anti-Mouse, mohala oa IgG o koahetsoe ka Mouse anti-Human IgG antibody.Ha palo e lekaneng ea mohlala oa teko e kenngoa ka har'a seliba sa sampuli sa k'hasete ea teko, mohlala ona o falla ka ketso ea capillary ho pholletsa le khasete.IgM anti-Novel coronavirus, haeba e le teng ka har'a mohlala, e tla hokahana le likhokahano tsa Novel coronavirus.The immunocomplex e ntan'o hapuoa ke reagent e kentsoeng pele ho sehlopha sa IgM, e etsa mohala oa burgundy oa IgM, o bonts'ang sephetho sa tlhahlobo e ntle ea Novel coronavirus IgM.IgG anti-Novel coronavirus haeba e le teng ka har'a mohlala e tla tlama ho likhokahano tsa Novel coronavirus.The immunocomplex e ntan'o hapuoa ke reagent e koahetsoeng moleng oa IgG, e etsa mohala oa IgG oa 'mala oa burgundy, o bonts'ang sephetho sa tlhahlobo ea Novel coronavirus IgG.Ho ba sieo ha mehala ea T (IgG le IgM) ho fana ka maikutlo a sephetho se fosahetseng.E le hore e sebetse e le taolo ea mekhoa, mohala o mebala o tla lula o hlaha sebakeng sa taolo e bontšang hore molumo o nepahetseng oa mohlala o kentsoe 'me ho se ho e-na le li-membrane wicking.

[TEMOHELO LE MEKELO]
Bakeng sa litsebi tsa bophelo bo botle le litsebi sebakeng sa libaka tsa tlhokomelo.
Se ke oa sebelisa kamora letsatsi la ho felloa ke nako.
Ka kopo bala lintlha tsohle tse pampiring 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 moemeli oa tšoaetso.
Khasete ea teko e sebelisitsoeng e lokela ho lahloa ho latela melao ea mmuso, ea naha le ea lehae.

[KE TLHAKISO]
Teko e na le lesela le koahetsoeng ka Mouse anti-Human IgM antibody le Mouse anti-Human IgG antibody moleng oa teko, le pente ea dae e nang le khauta e colloidal e kopantsoeng le antigen ea Novel coronavirus recombinant.
Bongata ba liteko bo ile ba hatisoa holim'a leibole.
Thepa e Fanoeng
Lekola cassettePackage kenya
Buffer
Lintho Tse Hlokahalang Empa li sa Fanoe
Setshelo sa pokello ea mohlalaTimer

[POLOKO LE BOTSITSO]
Boloka joalo ka ha e phuthetsoe ka mokotleng o koetsoeng 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 sehlahisoa.
LOT le letsatsi la ho felloa ke nako li ile tsa hatisoa holim'a leibole.

[SEKELO]
Teko e ka sebelisoa ho etsa liteko tsa Whole Blood/Serum/Plasma.
Ho bokella mali a felletseng, serum kapa plasma ho latela lits'ebetso tse tloaelehileng tsa laboratori ea tleliniki.
Arola serum kapa plasma maling kapele kamoo ho ka khonehang ho qoba hemolysis.Sebelisa feela mehlala e hlakileng e se nang hemolyzed.
Boloka mehlala ho 2-8℃ (36-46℉) haeba e sa hlahlojoe hang-hang.Boloka mehlala ho 2-8℃ ho isa ho matsatsi a 7.Mehlala e lokela ho hoamisoa
-20 ℃ (-4℉) bakeng sa polokelo e telele.U se ke ua hatsetsa mehlala eohle ea mali.
Qoba linako tse ngata tsa ho qhibiliha ha leqhoa.Pele o etsa liteko, tlisa mehlala e hatselitsoeng mochesong oa kamore butle 'me u kopanye ka bonolo.Mehlala e nang le likaroloana tse bonahalang li lokela ho hlakisoa ka centrifugation pele ho hlahlojoa.
Se ke oa sebelisa lisampole tse bontšang gross lipemia, gross hemolysis kapa turbidity ho qoba ho kena-kenana le tlhaloso ea sephetho.

[TEKA TS'EBETSO]
Dumella sesebediswa sa teko le disampole ho lekana mocheso (15-30℃kapa 59-86℉) pele ho tekolo.
1.Tlosa khasete ea teko mokotleng o tiisitsoeng.
2.Tšoara dropper ka ho otloloha 'me u fetisetse lerotholi le le leng la mohlala ho setšoantšo sa hantle(S) sa sesebelisoa sa teko, ebe u eketsa marotholi a 2 a buffer (hoo e ka bang 70μl) ebe u qala sebali sa nako.Sheba setšoantšo se ka tlase.
3.Emela hore mela e mebala e hlahe.Hlalosa liphetho tsa liteko ka mor'a metsotso e 15.Se ke oa bala liphetho kamora metsotso e 20.

[TOTOLLO EA LIPOTSO]
Positive: Control line le bonyane mola o le mong oa teko o hlaha lera.Ponahalo ea mohala oa liteko oa IgG e bonts'a boteng ba li-antibodies tsa IgG tsa Novel coronavirus.Ponahalo ea mohala oa liteko oa IgM e bonts'a boteng ba li-antibodies tsa Novel coronavirus tse ikhethang tsa IgM.Mme ha mehala ea IgG le IgM ka bobeli e hlaha, e bontša hore boteng ba li-antibodies tsa Novel coronavirus tse ikhethang tsa IgG le IgM.
Negative: Mohala o le mong oa 'mala o hlaha sebakeng sa taolo(C) .Ha ho mola o hlakileng o hlahang sebakeng sa mohala oa teko.
Ha e sebetse: Taolo ea mohala ha e hlahe.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 ka k'hasete e ncha ea teko.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.

[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]
AMRDT100 IgG/IgM Rapid Test Cassette e lekanyelitsoe ho fana ka tlhahlobo ea boleng.Botebo ba mohala oa teko ha bo hlile ha bo amahane le ho tsepama ha sesole sa 'mele maling.
Liphetho tse fumanoeng tlhahlobong ena li reretsoe hore e be thuso feela ho hlahlojoang.Ngaka e 'ngoe le e 'ngoe e tlameha ho hlalosa liphetho hammoho le histori ea mokuli, liphuputso tsa' mele, le mekhoa e meng ea ho hlahloba.
Sephetho se fosahetseng se bontša hore li-antibodies ho Novel coronavirus ha li teng kapa li maemong a sa bonahaleng ke tlhahlobo.

[DITLHAKISO TSA SEBETSI]
Ho nepahala
Papiso e bapileng le e 'ngoe e entsoe ka Novel coronavirus IgG/IgM Rapid Test le PCR e etelletseng pele ea khoebo.Ho ile ha hlahlobjoa mehlala ea kliniki e 120 ho tsoa sebakeng sa Professional Point of Care.Liphetho tse latelang li thathamisitsoe ho tsoa lithutong tsena tsa bongaka:
Papiso ea lipalo-palo e entsoe pakeng tsa liphetho tse fanang ka kutloisiso ea 90.00%, e ikhethang ea 97.78% le ho nepahala ha 95.83%.
Cross-Reactivity le Tšitiso
1.Mahlahana a mang a tloaelehileng a bakang mafu a tšoaetsanoang a ile a hlahlojoa bakeng sa ts'ebetso ea sefapano ka teko.Mehlala e meng e metle ea mafu a mang a tšoaetsanoang a tloaelehileng e ile ea kenngoa mefuteng ea Novel coronavirus e ntle le e mpe 'me ea hlahlojoa ka thoko.Ha ho reactivity ea sefapano e ileng ea hlokomeloa ka mehlala e tsoang ho bakuli ba nang le tšoaetso ea HIV, HAV, HBsAg, HCV, HTLV, CMV, FLUA, FLUB, RSV le TP.
2. Lintho tse ka 'nang tsa e-ba le li-endogenous tse fapaneng tse kenyelletsang likarolo tse tloaelehileng tsa serum, joalo ka lipids, hemoglobin, bilirubin, li ile tsa kenngoa ka bongata ho Novel coronavirus mehlala e metle le e fosahetseng' me ea lekoa ka thoko.Ha ho reactivity ea sefapano kapa tšitiso e ileng ea hlokomeloa ho sesebelisoa.
3. Bahlahlobisisi ba bang ba tloaelehileng ba baeloji ba ile ba hlohlelletsoa mehlala ea Novel coronavirus e ntle le e mpe 'me ea lekoa ka thoko.Ha ho tšitiso e kholo e ileng ea bonoa maemong a thathamisitsoeng tafoleng e ka tlase.

Ho ikatisa
Lithuto tsa ho ikatisa li entsoe bakeng sa Teko e Potlakileng ea Novel coronavirus IgG/IgM lilaboratoring tse tharo tsa ofisi ea lingaka (POL).Liphuputsong tsena ho sebelisitsoe mehlala ea serum ea kliniki e mashome a tšeletseng (60), 20 negative, 20 borderline positive le 20 positive.Mohlala o mong le o mong o ne o tsamaisoa ka makhetlo a mararo ka matsatsi a mararo ho POL e 'ngoe le e 'ngoe.Litumellano tsa tlhahlobo ea intra-assay e ne e le 100%.Tumellano ea sebaka sa marang-rang e ne e le 100%.

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