Gwiritsani ntchito zidziwitso ndi ntchito za NEJM Gulu kukonzekera kukhala dokotala, kudzikundikira chidziwitso, kutsogolera bungwe lazaumoyo ndikulimbikitsa chitukuko cha ntchito yanu.
Yakwana nthawi yoti tisinthe malingaliro athu pakukhudzika kwa mayeso a Covid-19.Bungwe la US Food and Drug Administration (FDA) ndi gulu la asayansi pakadali pano likungoyang'ana kwambiri pakuzindikira, komwe kumayesa kuthekera kwa njira imodzi yodziwira kuti ma protein a virus kapena mamolekyu a RNA.Chofunika kwambiri, muyeso uwu umanyalanyaza nkhani ya momwe mungagwiritsire ntchito mayeso.Komabe, zikafika pakuwunika komwe United States ikufuna kwambiri, nkhani yake ndiyofunikira.Funso lofunika kwambiri siloti momwe molekyu ingadziwike bwino mu chitsanzo chimodzi, koma kodi matendawa angadziwike bwino mwa anthu pogwiritsa ntchito mayeso omwe aperekedwa ngati gawo la njira yodziwira?Kutengeka kwa dongosolo la mayeso.
Mapulogalamu oyezetsa wamba amatha kukhala ngati fyuluta ya Covid-19 pozindikira, kudzipatula komanso kusefa anthu omwe ali ndi kachilombo (kuphatikiza anthu asymptomatic).Kuyeza kukhudzika kwa dongosolo loyesera kapena fyuluta kumafuna kuti tiganizire zoyesererazo motere: pafupipafupi kagwiritsidwe ntchito, yemwe amagwiritsidwa ntchito, nthawi yomwe imagwira ntchito panthawi ya matenda, komanso ngati ikugwira ntchito.Zotsatira zidzabwezeredwa munthawi yake kuti zipewe kufalikira.1-3
Njira yopatsira matenda a munthu (mzere wabuluu) ikuwonetsedwa munjira ziwiri zoyang'anira (zozungulira) zokhala ndi chidwi chowunikira.Ma analytical sensitivity assay nthawi zambiri amachitidwa, pomwe ma analytical sensitivity assessment ndi osowa.Mayesero onse awiriwa amatha kuzindikira matendawa (ozungulira lalanje), koma ngakhale ali ndi mphamvu zochepa zowunikira, kuyesa kokha kwafupipafupi kungathe kuzizindikira mkati mwawindo lofalitsa (mthunzi), zomwe zimapangitsa kuti zikhale zogwira mtima kwambiri Fyuluta Chipangizo.Windo la polymerase chain reaction (PCR) lozindikira zenera (lobiriwira) musanayambe kudwala ndi lalifupi kwambiri, ndipo zenera lofananira (lofiirira) lomwe lingazindikiridwe ndi PCR pambuyo pa matenda ndi lalitali kwambiri.
Kuganizira za zotsatira za kugwiritsidwa ntchito mobwerezabwereza ndi lingaliro lodziwika bwino kwa madokotala ndi mabungwe olamulira;imapemphedwa nthawi iliyonse tikayesa mphamvu ya dongosolo lamankhwala osati mlingo umodzi.Ndikukula kwachangu kapena kukhazikika kwamilandu ya Covid-19 padziko lonse lapansi, tifunika kusuntha chidwi chathu kuchoka ku chidwi chocheperako kupita ku chidwi cha mayeso (kuchepa kwa kuthekera kwake kuzindikira bwino kuchuluka kwa mamolekyu ang'onoang'ono pachitsanzo. ) ndi mayeso Pulogalamuyi ikugwirizana ndi kukhudzika kwa kuzindikira matenda (anthu omwe ali ndi kachilombo amamvetsetsa kuti angathe kutenga kachilomboka panthawi yake kuti asawachotse mwa anthu ndikuletsa kufalikira kwa ena).Kuyezetsa koyenera, komwe kumakhala kotchipa mokwanira ndipo kumatha kugwiritsidwa ntchito pafupipafupi, kumakhala ndi chidwi chozindikira matenda omwe amatenga nthawi yake osafikira malire a mayeso oyambira (onani chithunzi).
Mayesero omwe timafunikira ndi osiyana kwambiri ndi omwe akugwiritsidwa ntchito pano, ndipo ayenera kuwunikiridwa mosiyana.Kuyezetsa kwachipatala kumapangidwira anthu omwe ali ndi zizindikiro, sikufuna mtengo wotsika, ndipo kumafuna kukhudzidwa kwakukulu.Malingana ngati pali mwayi woyesera, chidziwitso chotsimikizika chachipatala chingabwezedwe.Mosiyana ndi izi, kuyesa m'mapulogalamu owonetsetsa kuti achepetse kuchuluka kwa ma virus opumira m'gulu la anthu akuyenera kubweza zotsatira mwachangu kuti achepetse kufala kwa asymptomatic, ndipo akuyenera kukhala otsika mtengo komanso osavuta kuchita kuti alole kuyesa pafupipafupi - kangapo pa sabata.Kufalikira kwa SARS-CoV-2 kumawoneka kuti kumachitika patangopita masiku ochepa atadziwika, kuchuluka kwa ma virus kumafika pachimake.4 Mfundoyi pakapita nthawi imawonjezera kufunikira kwa kuyezetsa pafupipafupi, chifukwa kuyezetsa kuyenera kugwiritsidwa ntchito kumayambiriro kwa matenda kuti asapitirire kufalikira ndikuchepetsa kufunikira kokwaniritsa malire otsika kwambiri a maselo oyeserera.
Malinga ndi njira zingapo, mayeso a benchmark standard Clinical polymerase chain reaction (PCR) amalephera akagwiritsidwa ntchito poyang'anira.Pambuyo posonkhanitsa, zitsanzo za PCR nthawi zambiri zimafunika kutumizidwa ku labotale yapakati yopangidwa ndi akatswiri, zomwe zimawonjezera ndalama, zimachepetsa pafupipafupi, ndipo zimatha kuchedwetsa zotsatira ndi tsiku limodzi kapena awiri.Mtengo ndi kuyesetsa komwe kumafunika kuyesa pogwiritsa ntchito mayeso okhazikika kumatanthauza kuti anthu ambiri ku US sanayesedwepo, ndipo nthawi yochepa yosinthira imatanthauza kuti ngakhale njira zowunika zomwe zilipo zitha kuzindikira anthu omwe ali ndi kachilomboka, amatha kufalitsa matendawa kwa masiku angapo.M'mbuyomu, izi zidachepetsa mphamvu yakukhala kwaokha komanso kutsatira anthu omwe akulumikizana nawo.
Centers for Disease Control and Prevention (CDC) ikuyerekeza kuti pofika Juni 2020, chiwerengero cha anthu omwe apezeka ndi Covid-19 ku United States chidzakhala kuwirikiza ka 10 kuchuluka kwa omwe apezeka.5 Mwanjira ina, ngakhale kuwunika, njira zoyesera zamasiku ano zitha kuzindikira kukhudzika kwa 10% kwambiri ndipo sizingagwiritsidwe ntchito ngati fyuluta ya Covid.
Kuonjezera apo, pambuyo pa gawo lopatsirana, mchira wautali wa RNA-positive umafotokozedwa momveka bwino, zomwe zikutanthauza kuti, ngati si ambiri, anthu ambiri amagwiritsa ntchito chidziwitso chapamwamba kuti azindikire matenda panthawi yachizoloŵezi, koma sakhalanso opatsirana panthawi yomwe akudziwika. .Kuzindikira (onani chithunzi).2 M'malo mwake, kafukufuku waposachedwa ndi The New York Times adapeza kuti ku Massachusetts ndi New York, matenda opitilira 50% omwe adapezeka kudzera pakuwunika kwa PCR amakhala ndi PCR pakati pazaka zapakati pa 30 ndi 30s., Kuwonetsa kuti chiwerengero cha ma virus a RNA ndi chochepa.Ngakhale kuti chiwerengero chochepa chingasonyeze matenda oyambirira kapena mochedwa, kutalika kwa michira yokhala ndi RNA kumasonyeza kuti anthu ambiri omwe ali ndi kachilomboka adziwika pambuyo pa nthawi ya matenda.Zofunika kwambiri pazachuma, zimatanthauzanso kuti ngakhale adutsa njira yopatsirana, anthu masauzande ambiri akukhala kwaokha kwa masiku 10 pambuyo pa mayeso a RNA-positive.
Kuti tiyimitse zosefera za mliri wa Covid, tiyenera kuyesa kuti tipeze yankho lomwe limagwira matenda ambiri koma limapatsirana.Masiku ano, mayesowa alipo ngati mayeso othamanga a antigen othamanga, ndipo mayeso othamanga othamanga otengera ukadaulo wa CRISPR watsala pang'ono kuwonekera.Mayeso oterowo ndi otsika mtengo kwambiri (<5 USD), makumi mamiliyoni kapena kupitilira mayeso amatha kuchitidwa sabata iliyonse, ndipo amatha kuchitidwa kunyumba, kutsegulira chitseko chothandizira kusefa kwa Covid.Kuyesa kwa antigen kwapambuyo kulibe gawo lokulitsa, kotero kuti malire ake odziwika ndi 100 kapena 1000 nthawi ya mayeso a benchmark, koma ngati cholinga ndikuzindikira anthu omwe akufalitsa kachilomboka pakadali pano, izi sizothandiza.SARS-CoV-2 ndi kachilombo komwe kamatha kukula mwachangu mthupi.Chifukwa chake, zotsatira zoyeserera za PCR zikakhala zabwino, kachilomboka kamakula mwachangu.Pofika nthawiyo, zitha kutenga maola m'malo mwa masiku kuti kachilomboka kakule ndikufika pozindikira kuti kuyezetsa pompopompo komwe kulipo kotsika mtengo komanso kofulumira komwe kulipo.Pambuyo pake, anthu akapeza zotsatira zabwino m'mayesero onse awiri, amatha kuyembekezera kutenga kachilomboka (onani chithunzi).
Tikukhulupirira kuti mapulogalamu oyeserera omwe atha kudula unyolo wokwanira kuti achepetse kufala kwa anthu ammudzi ayenera kuwonjezera m'malo molowa m'malo mwa mayeso athu azachipatala.Njira yongoganizira imatha kugwiritsa ntchito mayeso awiriwa, pogwiritsa ntchito mayeso akulu, pafupipafupi, otsika mtengo komanso ofulumira kuti achepetse kufalikira, 1-3 pogwiritsa ntchito mayeso achiwiri othamanga a mapuloteni osiyanasiyana kapena kugwiritsa ntchito mayeso a benchmark PCR kuti atsimikizire zotsatira zabwino.Kampeni yodziwitsa anthu ikuyeneranso kuwonetsa mtundu uliwonse wamayeso oyipa omwe satanthauza thanzi, kuti alimbikitse kusamvana komanso kuvala masks.
FDA's Abbott BinaxNOW Emergency Use Authorization (EUA) kumapeto kwa Ogasiti ndi sitepe yolondola.Ndiko kuyesa koyamba kofulumira, kopanda zida za antigen kupeza EUA.Njira yovomerezeka ikugogomezera kukhudzidwa kwakukulu kwa mayesero, omwe amatha kudziwa nthawi yomwe anthu amatha kufalitsa matendawa, potero amachepetsa malire odziwika bwino ndi maulamuliro awiri a kukula kuchokera ku chiwerengero cha PCR.Mayeso ofulumirawa tsopano akuyenera kupangidwa ndikuvomerezedwa kuti azigwiritsidwa ntchito kunyumba kuti akwaniritse pulogalamu yowunika ya SARS-CoV-2.
Pakalipano, palibe njira ya FDA yowunikira ndikuvomereza kuyesa kuti agwiritsidwe ntchito mu ndondomeko ya chithandizo, osati ngati kuyesa kamodzi, ndipo palibe kuthekera kwaumoyo wa anthu kuchepetsa kufala kwa anthu.Mabungwe owongolera amangoyang'anabe zoyezetsa zachipatala, koma ngati cholinga chawo ndikuchepetsa kufalikira kwa kachiromboka m'deralo, zizindikiritso zatsopano zitha kugwiritsidwa ntchito poyesa mayeso potengera dongosolo la miliri.M'njira yovomerezeka iyi, kugulitsana pakati pa mafupipafupi, malire odziwika ndi nthawi yosinthika akhoza kuyembekezera ndikuyesedwa moyenera.1-3
Kuti tigonjetse Covid-19, tikukhulupirira kuti FDA, CDC, National Institutes of Health ndi mabungwe ena akuyenera kulimbikitsa kuwunika koyenera kwa mayeso malinga ndi mapulogalamu oyeserera omwe adakonzedwa kuti adziwe pulogalamu yoyeserera yomwe ingapereke fyuluta yabwino kwambiri ya Covid.Kugwiritsa ntchito pafupipafupi mayeso otsika mtengo, osavuta, komanso othamanga kumatha kukwaniritsa cholinga ichi, ngakhale kukhudzika kwawo kukakhala kocheperako kuposa kuyesa kwa benchmark.1 Dongosolo lotereli litha kutithandizanso kupewa kukula kwa Covid.
Boston Harvard Chenchen School of Public Health (MJM);ndi University of Colorado Boulder (RP, DBL).
1. Larremore DB, Wilder B, Lester E, ndi ena. Poyang'aniridwa ndi COVID-19, kukhudzika kwa mayeso ndi kwachiwiri kokha kufupipafupi komanso nthawi yosinthira.Seputembara 8, 2020 (https://www.medrxiv.org/content/10.1101/2020.06.22.20136309v2).Kusindikizatu.
2. Paltiel AD, Zheng A, Walensky RP.Unikani njira yowunikira ya SARS-CoV-2 kuti mulole kutsegulidwanso kotetezeka kwa mayunivesite ku United States.JAMA Cyber Open 2020;3 (7): e2016818-e2016818.
3. Chin ET, Huynh BQ, Chapman LAC, Murrill M, Basu S, Lo NC.Kuchuluka kwa kuyezetsa kwanthawi zonse kwa COVID-19 m'malo omwe ali pachiwopsezo chachikulu kuti achepetse kufalikira kwa malo antchito.Seputembara 9, 2020 (https://www.medrxiv.org/content/10.1101/2020.04.30.20087015v4).Kusindikizatu.
4. He X, Lau EHY, Wu P, ndi zina zotero. Kusinthasintha kwa nthawi ya kukhetsa ma virus ndi kufalikira kwa COVID-19.Nat Med 2020;26:672-675.
5. Malo Othandizira Kuletsa ndi Kupewa Matenda.Zolemba zachidule cha foni chaposachedwa cha CDC pa COVID-19.Juni 25, 2020 (https://www.cdc.gov/media/releases/2020/t0625-COVID-19-update.html).
Njira yopatsira matenda a munthu (mzere wabuluu) ikuwonetsedwa munjira ziwiri zoyang'anira (zozungulira) zokhala ndi chidwi chowunikira.Ma analytical sensitivity assay nthawi zambiri amachitidwa, pomwe ma analytical sensitivity assessment ndi osowa.Mayesero onse awiriwa amatha kuzindikira matendawa (ozungulira lalanje), koma ngakhale ali ndi mphamvu zochepa zowunikira, kuyesa kokha kwafupipafupi kungathe kuzizindikira mkati mwawindo lofalitsa (mthunzi), zomwe zimapangitsa kuti zikhale zogwira mtima kwambiri Fyuluta Chipangizo.Windo la polymerase chain reaction (PCR) lozindikira zenera (lobiriwira) musanayambe kudwala ndi lalifupi kwambiri, ndipo zenera lofananira (lofiirira) lomwe lingazindikiridwe ndi PCR pambuyo pa matenda ndi lalitali kwambiri.
Nthawi yotumiza: Mar-11-2021