Abstract
Tsis ntev los no, Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com) SARS-CoV-2 lgM/IgG Antibody Rapid Test Kit tau raug lees paub los ntawm Brazilian National Health Supervision Bureau thiab tau txais daim ntawv pov thawj ANVISA.Nyob rau tib lub sijhawm, SARS-CoV-2 RT-PCR thiab IgM/IgG cov khoom siv tshuaj tiv thaiv kab mob sai kuj tau teev nyob rau hauv daim ntawv teev npe kev yuav khoom ntawm Indonesia.Meanwhile, Liming Bio StrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-time PCR Kit, tau pom zoo los ntawm Singapore Health Sciences Authority (HSA), thiab tau txais daim ntawv pov thawj HSA.
Daim duab 1 Brazil ANVISA ntawv pov thawj
Brazil (ANVISA) ntawv pov thawj
ANVISA, lub npe hu ua Agência Nacional de Vigilância Sanitária, yog tus tswj hwm kev kho mob hauv Brazil.Nws yog qhov tsim nyog rau lub tuam txhab yuav tsum tau sau npe nrog ANVISA, Lub Chaw Saib Xyuas Kev Noj Qab Haus Huv Hauv Tebchaws, kom muag cov cuab yeej kho mob raug cai hauv Brazil.Yuav kom tau txais kev lees paub, cov khoom siv kho mob nkag mus hauv Brazil yuav tsum ua raws li cov cai ntawm Brazilian GMP nrog rau cov qauv tshwj xeeb uas tau teev tseg los ntawm Brazilian cov tub ceev xwm.Hauv tebchaws Brazil, IVD cov cuab yeej kho mob tau muab faib rau hauv Chav Kawm I, II, III, thiab IV raws li kev pheej hmoo ntawm qib qis mus rau siab.Rau cov khoom siv hauv chav kawm I thiab II, Cadastro txoj hauv kev tau txais kev pom zoo, thaum rau Class III thiab IV cov khoom, Registro mus kom ze yog siv.Tom qab kev tso npe ua tiav, tus lej sau npe yuav raug muab los ntawm ANVISA, thiab cov ntaub ntawv yuav raug xa mus rau hauv Brazilian cov ntaub ntawv kho mob, tus lej no thiab nws cov ntaub ntawv sau npe sib raug yuav tshwm sim ntawm DOU (Diário Oficial da União).
Daim duab 2 Singapore Health Sciences Authority (HSA) daim ntawv pov thawj
Daim duab 3 Daim ntawv pom zoo yuav khoom ntawm Indonesia
Daim duab 4 StrongStep®SARS-CoV-2 IgM/IgG Antibody Rapid Test
Daim duab 5 Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR kit
Nco tseg:
Cov khoom siv PCR zoo heev, npaj rau siv no muaj nyob rau hauv hom lyophilized (txheej txheej txheem kom qhuav) rau kev cia ntev.Cov khoom siv tuaj yeem thauj thiab khaws cia hauv chav sov thiab ruaj khov rau ib xyoos.Txhua lub raj ntawm premix muaj tag nrho cov reagents xav tau rau PCR amplification, suav nrog Reverse-transcriptase, Taq polymerase, primers, probes, thiab dNTPs substrates.Nws tsuas yog xav tau ntxiv 13ul distilled dej thiab 5ul rho tawm RNA template, ces nws tuaj yeem khiav thiab nthuav dav ntawm PCR cov cuab yeej.
Qhov nyuaj ntawm kev thauj mus los txias ntawm Novel Coronavirus nucleic acid detection reagent
Thaum cov pa nucleic acid nrhiav pom reagents raug thauj mus rau qhov ntev, qhov (-20 ± 5) ℃ txias saw thiab tsheb thauj mus los yuav tsum tau ua kom ntseeg tau tias bioactive enzyme hauv cov reagents tseem ua haujlwm.Txhawm rau kom paub tseeb tias qhov ntsuas kub nce mus txog tus qauv, ob peb kilograms ntawm cov dej khov qhuav yog xav tau rau txhua lub thawv ntawm nucleic acid kuaj reagent txawm tias tsawg dua 50g, tab sis nws tuaj yeem kav ntev li ob lossis peb hnub.Ntawm qhov kev xav ntawm kev lag luam xyaum, qhov tseeb qhov hnyav ntawm cov tshuaj reagents tawm los ntawm cov tuam txhab tsim khoom tsawg dua 10% (lossis deb tshaj qhov nqi no) ntawm lub thawv.Feem ntau ntawm qhov hnyav yog los ntawm cov dej khov qhuav, cov ntim dej khov thiab cov thawv ua npuas dej, yog li tus nqi tsheb thauj mus los yog siab heev.
Thaum Lub Peb Hlis 2020, COVID-19 tau pib tawg tawm hauv qhov loj hauv txawv teb chaws, thiab qhov kev thov rau Novel Coronavirus nucleic acid kuaj pom reagent tau nce ntau.Txawm hais tias tus nqi siab ntawm kev xa tawm cov reagents nyob rau hauv cov kab mob khaub thuas, feem ntau cov tuam ntxhab tseem tuaj yeem txais nws vim qhov ntau thiab cov txiaj ntsig siab.
Txawm li cas los xij, nrog rau kev txhim kho cov cai xa tawm hauv tebchaws rau cov khoom lag luam tiv thaiv kev sib kis, nrog rau kev txhim kho kev tswj hwm lub teb chaws ntawm kev khiav ntawm tib neeg thiab kev thauj mus los, muaj qhov txuas ntxiv thiab tsis paub meej hauv lub sijhawm thauj mus los ntawm cov tshuaj reagents, uas ua rau cov khoom lag luam muaj teeb meem tshwm sim. los ntawm kev thauj mus los.Kev ncua sij hawm thauj mus los (lub sijhawm thauj mus los ntawm ib nrab ntawm ib hlis yog qhov ntau heev) ua rau cov khoom lag luam tsis tu ncua thaum cov khoom mus txog tus neeg siv khoom.Qhov no tau teeb meem feem ntau nucleic acid reagents export lag luam.
Lyophilized thev naus laus zis rau PCR reagent pab kev thauj mus los ntawm Novel Coronavirus nucleic acid nrhiav reagent thoob ntiaj teb
Cov lyophilized PCR reagents tuaj yeem thauj thiab khaws cia hauv chav sov, uas tuaj yeem tsis tsuas yog txo tus nqi thauj mus los, tab sis kuj zam cov teeb meem zoo los ntawm kev thauj mus los.Yog li ntawd, lyophilizing cov reagent yog qhov zoo tshaj plaws los daws qhov teeb meem ntawm kev thauj mus los.
Lyophilization suav nrog kev tso dej khov rau hauv lub xeev khov, thiab tom qab ntawd sublimate thiab cais cov dej vapor nyob rau hauv lub tshuab nqus tsev.Lub qhuav solute tseem nyob rau hauv lub thawv nrog tib yam muaj pes tsawg leeg thiab kev ua si.Piv nrog rau cov pa ua kua reagents, tag nrho cov khoom xyaw lyophilized Novel Coronavirus nucleic acid nrhiav reagent tsim los ntawm Liming Bio muaj cov yam ntxwv hauv qab no:
Muaj zog kub ruaj khov: nws tuaj yeem nrog kev kho mob ntawm 56 ℃ rau 60 hnub, thiab morphology thiab kev ua haujlwm ntawm cov reagent tseem tsis hloov pauv.
Kev khaws cia kub thiab kev thauj mus los: tsis tas yuav tsum muaj cov hlua txias, tsis tas yuav khaws cia ntawm qhov kub thiab txias ua ntej unsealing, tag nrho tso tawm qhov chaw txias txias.
Npaj-rau-siv: lyophilizing ntawm tag nrho cov Cheebtsam, tsis xav tau rau lub system configuration, tsis txhob poob ntawm cov khoom uas muaj viscosity siab xws li enzyme.
Multiplex lub hom phiaj nyob rau hauv ib lub raj: lub hom phiaj tshawb nrhiav npog cov kab mob tshiab coronavirus ORF1ab gene, N gene, S gene kom zam dhau tus kab mob genovariation.Txhawm rau txo qis qhov tsis zoo, tib neeg RNase P noob tau siv los ua kev tswj hwm sab hauv, kom ua tau raws li qhov xav tau ntawm kev kho mob rau cov qauv kev tswj xyuas zoo.
SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (nrhiav peb genes) yav dhau los tau CE cim hauv UK, thiab tam sim no lees txais thiab ua tiav los ntawm EUA ntawm FDA hauv Asmeskas.
Nanjing Liming Bio-Products Co., Ltd. yeej ib txwm muab qhov zoo ntawm cov khoom siv kuaj hauv thawj qhov chaw, thiab tsom mus rau kev nthuav dav ntawm lub peev xwm.Lub tuam txhab yuav muab cov khoom siv tshuaj ntsuam xyuas zoo thiab cov kev pabcuam zoo rau COVID-19 rau cov tsev kho mob thoob plaws ntiaj teb, thiab pab txhawb rau kev tiv thaiv thiab kev tswj hwm thoob ntiaj teb, txhawm rau tsim kom muaj lub ntiaj teb kev sib koom ua ke yav tom ntej.
Xovxwm Ntev ~ Scan thiab Ua Raws Li Peb
Email:sales@limingbio.com
Lub Vev Xaib: https://limingbio.com
Post lub sij hawm: Jul-06-2020