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Ma'aikatan kiwon lafiya sun gudanar da wani babban gwaji ta amfani da gwajin maganin antigen cikin sauri a wata makaranta a Faransa.Hoton hoto: Thomas Samson/AFP/Getty
Kamar yadda adadin cututtukan coronavirus a Burtaniya ya karu a farkon 2021, gwamnati ta ba da sanarwar yuwuwar canjin wasa a cikin yaƙi da COVID-19: miliyoyin arha, gwaje-gwajen ƙwayoyin cuta.A ranar 10 ga Janairu, ta bayyana cewa za ta inganta wadannan gwaje-gwajen a duk fadin kasar, har ma ga mutanen da ba su da alamun cutar.Irin wannan gwaje-gwajen za su taka muhimmiyar rawa a shirin Shugaba Joe Biden na shawo kan annobar da ta barke a Amurka.
Waɗannan gwaje-gwaje masu sauri yawanci suna haɗa hanci ko makogwaro tare da ruwa akan tsiri na takarda don dawo da sakamakon cikin rabin sa'a.Ana ɗaukar waɗannan gwaje-gwajen gwaje-gwaje masu yaduwa, ba gwaje-gwaje masu yaduwa ba.Za su iya gano manyan nau'ikan ƙwayoyin cuta kawai, don haka za su yi kewar mutane da yawa waɗanda ke da ƙananan matakan ƙwayar cuta na SARS-CoV-2.Amma fatan da ake da shi shi ne za su taimaka wajen shawo kan cutar ta hanyar hanzarta gano wadanda suka kamu da cutar, in ba haka ba za su iya yada cutar ba tare da saninsu ba.
Sai dai kamar yadda gwamnati ta sanar da shirin, an samu cece-kuce a fusace.Wasu masana kimiyya sun gamsu da dabarun gwajin Burtaniya.Wasu kuma sun ce waɗannan gwaje-gwajen ba za su rasa kamuwa da cuta da yawa waɗanda idan aka bazu zuwa miliyoyi, illar da za su iya haifarwa ta zarce cutar.Jon Deeks, wanda kwararre ne a fannin gwaje-gwaje da tantancewa a Jami’ar Birmingham da ke Burtaniya, ya yi imanin cewa, mutane da yawa za su iya samun sauki daga sakamakon gwajin da ba su dace ba kuma su canza halayensu.Kuma, in ji shi, idan mutane suka gudanar da gwaje-gwajen da kansu, maimakon dogaro da kwararrun kwararru, wadannan gwaje-gwajen za su rasa wasu cututtuka.Shi da abokin aikinsa na Birmingham Jac Dinnes (Jac Dinnes) masana kimiyya ne, kuma suna fatan suna buƙatar ƙarin bayanai kan saurin gwajin coronavirus kafin a iya amfani da su sosai.
Amma sauran masu binciken ba da daɗewa ba suka yi yaƙi da baya, suna da'awar cewa gwajin na iya haifar da lahani ba daidai ba ne kuma "rashin nauyi" (duba go.nature.com/3bcyzfm).Daga cikin su akwai Michael Mina, masanin cututtukan dabbobi a Makarantar Kiwon Lafiyar Jama'a ta Harvard TH Chan da ke Boston, Massachusetts, wanda ya ce wannan gardama tana jinkirta hanyar da ake bukata don magance cutar.Ya ce: "Har yanzu muna cewa ba mu da isassun bayanai, amma muna tsakiyar yakin - dangane da adadin kararraki, da gaske ba za mu yi muni fiye da kowane lokaci ba."
Iyakar abin da masana kimiyya suka yarda da shi shi ne cewa akwai buƙatar samun cikakkiyar sadarwa game da abin da gwajin sauri yake da kuma abin da mummunan sakamako ke nufi.Mina ta ce, "Jifa kayan aiki ga mutanen da ba su san yadda ake amfani da su yadda ya kamata ba mummunan ra'ayi ne."
Yana da wuya a sami ingantaccen bayani don gwaje-gwaje masu sauri, saboda-aƙalla a cikin Turai-samfuran za a iya siyar da su kawai dangane da bayanan masana'anta ba tare da kima mai zaman kansa ba.Babu daidaitattun ka'idoji don auna aikin, don haka yana da wahala a kwatanta ƙima da tilasta kowace ƙasa ta gudanar da nata tabbaci.
Catharina Boehme, Shugaba na Innovative New Diagnostics Foundation (FIND), wata kungiya mai zaman kanta a Geneva, Switzerland wacce ta sake tantancewa tare da kwatanta yawancin hanyoyin Binciken COVID-19.
A cikin Fabrairu 2020, FIND ta fara aiki mai ban sha'awa don kimanta ɗaruruwan nau'ikan gwajin COVID-19 a daidaitattun gwaje-gwaje.Gidauniyar tana aiki tare da Hukumar Lafiya ta Duniya (WHO) da cibiyoyin bincike na duniya don gwada ɗaruruwan samfuran coronavirus tare da kwatanta ayyukansu da waɗanda aka samu ta amfani da fasahar polymerase chain reaction (PCR).Fasahar tana neman takamaiman jeri na ƙwayoyin cuta na ƙwayoyin cuta a cikin samfuran da aka ɗauka daga hanci ko makogwaron mutum (wani lokacin yau).Gwaje-gwaje na tushen PCR na iya yin kwafi fiye da wannan kwayoyin halitta ta hanyar haɓakawa da yawa, don haka za su iya gano adadin farko na parvovirus.Amma suna iya ɗaukar lokaci kuma suna buƙatar ƙwararrun ma'aikata da kayan aikin dakin gwaje-gwaje masu tsada (duba "Yadda Gwajin COVID-19 ke Aiki").
Gwaje-gwaje masu arha, mai sauri na iya aiki sau da yawa ta hanyar gano takamaiman sunadaran (wanda ake kira antigens tare) akan saman sassan SARS-CoV-2.Wadannan "gwajin antigen cikin sauri" ba sa haɓaka abubuwan da ke cikin samfurin, don haka za a iya gano kwayar cutar ne kawai lokacin da kwayar cutar ta kai matsayi mai girma a cikin jikin mutum - za a iya samun dubban kwafin kwayar cutar a kowace millilita na samfurin.Lokacin da mutane suka fi kamuwa da cuta, ƙwayar cuta takan kai waɗannan matakan a lokacin fara bayyanar cututtuka (duba “Catch COVID-19″).
Dinnes ya ce bayanan masana'anta kan hankalin gwaji sun fito ne daga gwaje-gwajen dakin gwaje-gwaje a cikin mutanen da ke da alamun kamuwa da kwayar cutar hoto.A cikin waɗancan gwaje-gwajen, gwaje-gwaje masu sauri da yawa sun yi kama sosai.(Suna da ƙayyadaddun ƙayyadaddun bayanai: ba za su iya ba da sakamako mai kyau ba.) Duk da haka, sakamakon kimantawa na ainihi ya nuna cewa mutanen da ke da ƙananan ƙwayoyin cuta suna nuna bambanci daban-daban.
Yawan ƙwayar cuta a cikin samfurin yawanci ana ƙididdige shi tare da la'akari da adadin hawan PCR da ake buƙata don gano ƙwayoyin cuta.Gabaɗaya, idan ana buƙatar kusan zagayowar haɓakawa na PCR 25 ko ƙasa da haka (wanda ake kira ƙofar zagayowar, ko Ct, daidai da ko ƙasa da 25), to ana ɗaukar matakin ƙwayar cuta mai girma, yana nuna cewa mutane na iya kamuwa da cuta - kodayake ba tukuna ba. a bayyane yake ko mutane suna da ko basu da mahimmancin matakin yaduwa.
A watan Nuwamban bara, gwamnatin Burtaniya ta fitar da sakamakon binciken farko da aka gudanar a Porton Down Science Park da Jami'ar Oxford.Duk sakamakon da har yanzu ba a sake nazarin takwarorinsu ba, an buga su ta yanar gizo a ranar 15 ga Janairu. Waɗannan sakamakon sun nuna cewa duk da cewa yawancin gwaje-gwajen antigen mai sauri (ko “lafiya ta gefe”) “ba su kai matakin da ake buƙata don tura yawan jama’a ba,” a cikin Gwajin dakin gwaje-gwaje, alamomin mutum 4 suna da dabi'un CT ko ƙananan 25. Nemo damar sake gwajin kayan girki da yawa sune 90% ko sama.
Yayin da ƙwayar ƙwayar cuta ta ragu (watau ƙimar Ct ta tashi), gwaje-gwaje masu sauri sun fara rasa kamuwa da cuta.Masana kimiyya a Porton Down sun ba da kulawa ta musamman ga gwajin Innova Medical a Pasadena, California;Gwamnatin Burtaniya ta kashe sama da fam miliyan 800 (dala biliyan 1.1) don yin odar wadannan gwaje-gwajen, wani muhimmin bangare na dabarunta na sassauta yaduwar cutar ta coronavirus.A matakin Ct na 25-28, an rage azancin gwajin zuwa 88%, kuma don matakin Ct na 28-31, an rage gwajin zuwa 76% (duba "Gwajin Saurin Nemo Babban Load ɗin Kwayar cuta").
Sabanin haka, a cikin Disamba, Abbott Park, Illinois, Abbott Laboratories sun kimanta gwajin saurin BinaxNOW tare da sakamako mara kyau.Binciken ya gwada fiye da mutane 3,300 a San Francisco, California, kuma ya sami 100% hankali ga samfuran da matakan Ct da ke ƙasa da 30 (ko da wanda ya kamu da cutar bai nuna alamun ba)2.
Koyaya, tsarin PCR daban-daban yana nufin ba za a iya kwatanta matakan Ct cikin sauƙi tsakanin dakunan gwaje-gwaje ba, kuma ba koyaushe yana nuna cewa matakan ƙwayoyin cuta a cikin samfuran iri ɗaya ne ba.Innova ya ce binciken Burtaniya da Amurka sun yi amfani da tsarin PCR daban-daban, kuma kwatancen kai tsaye akan tsarin iri ɗaya ne kawai zai yi tasiri.Sun yi nuni da wani rahoton gwamnatin Biritaniya da masana kimiyyar Porton Down suka rubuta a karshen watan Disamba wanda ya hada gwajin Innova da gwajin Abbott Panbio (mai kama da kayan BinaxNOW da Abbott ya sayar a Amurka).A cikin sama da samfuran 20 tare da matakin Ct a ƙasa 27, samfuran duka sun dawo da sakamako mai kyau 93% (duba go.nature.com/3at82vm).
Lokacin da aka yi la'akari da gwajin Innova akan dubban mutane a Liverpool, Ingila, abubuwan da suka shafi Ct calibration suna da mahimmanci, wanda kawai ya gano kashi biyu cikin uku na lokuta tare da matakan Ct da ke ƙasa da 25 (duba go.nature.com) /3tajhkw).Wannan yana nuna cewa waɗannan gwaje-gwajen sun rasa kashi uku na masu iya kamuwa da cuta.Koyaya, yanzu an yi imani cewa a cikin dakin gwaje-gwaje da ke aiwatar da samfuran, ƙimar Ct na 25 daidai yake da ƙaramin matakin ƙwayar cuta a cikin sauran dakunan gwaje-gwaje (watakila daidai yake da Ct na 30 ko sama), in ji Iain Buchan, mai bincike a Lafiya. da Informatics a Jami'ar Amurka.Liverpool, ita ce ta jagoranci shari'ar.
Duk da haka, ba a san cikakkun bayanai ba.Dix ya ce gwajin da jami'ar Birmingham ta gudanar a watan Disamba misali ne na yadda gwajin gaggawar ya rasa kamuwa da cuta.Fiye da ɗaliban asymptomatic 7,000 a can sun ɗauki gwajin Innova;2 ne kawai aka gwada tabbatacce.Koyaya, lokacin da masu binciken jami'a suka yi amfani da PCR don sake duba kashi 10% na samfuran marasa kyau, sun sami ƙarin ɗalibai shida da suka kamu da cutar.Dangane da rabon samfuran duka, ƙila gwajin ya rasa ɗalibai 60 da suka kamu da cutar3.
Mina ta ce wadannan daliban suna da karancin kwayoyin cutar, don haka ba sa yaduwa ta kowace hanya.Dix ya yi imanin cewa ko da yake mutanen da ke da ƙananan ƙwayoyin ƙwayoyin cuta na iya kasancewa a ƙarshen matakan raguwar kamuwa da cuta, suna iya zama masu yaduwa.Wani abu kuma shi ne cewa wasu dalibai ba su da kyau wajen tattara samfuran swab, don haka ƙwayoyin ƙwayoyin cuta da yawa ba za su iya cin jarabawar ba.Yana damuwa da cewa mutane za su yi kuskuren yarda cewa cin jarabawar mara kyau na iya tabbatar da amincin su-a zahiri, gwaji mai sauri hoto ne kawai wanda maiyuwa ba zai kamu da cutar ba a lokacin.Deeks ya ce da'awar cewa gwaji na iya sanya wurin aiki gaba daya lafiya ba hanya ce da ta dace don sanar da jama'a ingancin sa ba.Ya ce: "Idan mutane suna da rashin fahimta game da tsaro, za su iya yada wannan kwayar cutar."
Amma Mina da wasu sun ce matukan jirgin Liverpool sun shawarci mutane da kada su yi hakan kuma an gaya musu cewa suna iya yada cutar nan gaba.Mina ta jaddada cewa yawan amfani da gwaji (kamar sau biyu a mako) shine mabuɗin yin gwajin tasiri don ɗaukar cutar.
Fassarar sakamakon gwajin ya dogara ba kawai akan daidaiton gwajin ba, har ma da damar cewa mutum ya riga ya sami COVID-19.Ya danganta da yawan kamuwa da cuta a yankinsu da ko sun nuna alamun.Idan mutum daga yankin da ke da babban matakin COVID-19 yana da alamun cutar na yau da kullun kuma ya sami sakamako mara kyau, yana iya zama mara kyau na ƙarya kuma yana buƙatar bincika a hankali ta amfani da PCR.
Masu bincike kuma suna muhawara ko ya kamata mutane su gwada kansu (a gida, makaranta ko aiki).Ayyukan gwajin na iya bambanta, dangane da yadda mai gwadawa ke tattara swab da sarrafa samfurin.Misali, ta amfani da gwajin Innova, masana kimiyyar dakin gwaje-gwaje sun kai kusan kashi 79% na duk samfuran (ciki har da samfuran da ke da ƙananan nauyin hoto), amma jama'a masu koyar da kansu kawai suna samun azanci na 58% (duba "Gwajin Saurin): Shin ya dace da gida?”) -Deeks ya yi imanin cewa wannan faɗuwar damuwa ce1.
Duk da haka, a cikin Disamba, hukumar kula da magunguna ta Burtaniya ta ba da izinin yin amfani da fasahar gwajin Innova a cikin gida don gano cututtuka a cikin mutanen da ba su da lafiya.Kakakin DHSC ya tabbatar da cewa alamun kasuwancin wadannan gwaje-gwajen sun fito ne daga Hukumar Kula da Lafiya ta Kasa, wanda Ma'aikatar Lafiya da Kula da Jama'a (DHSC) ta tsara, amma an saya daga Innova kuma kamfanin Xiamen Biotechnology Co., Ltd ya samar. Gwajin da gwamnatin Biritaniya ta yi amfani da shi an tantance shi sosai daga manyan masana kimiyya na Burtaniya.Wannan yana nufin cewa sun kasance daidai, abin dogaro, kuma suna iya samun nasarar gano marasa lafiyar COVID-19 asymptomatic. ”Kakakin ya ce a cikin wata sanarwa.
Wani bincike na Jamusanci4 ya nuna cewa gwaje-gwajen da aka yi da kansu na iya yin tasiri kamar na ƙwararru.Ba a sake nazarin wannan binciken ba.Binciken ya gano cewa lokacin da mutane ke goge hancinsu kuma suka kammala gwajin gaggawar da ba a san sunansu ba da WHO ta amince da su, ko da a lokuta da yawa mutane sukan kauce wa umarnin amfani, har yanzu hankalin yana kama da wanda kwararru ke samu.
A cikin Amurka, Hukumar Abinci da Magunguna (FDA) ta amince da izinin yin amfani da gaggawa don gwaje-gwajen antigen guda 13, amma ɗayan gwajin gida na Ellume COVID-19-ana iya amfani da shi ga mutanen asymptomatic.A cewar Ellume, wani kamfani da ke Brisbane, Australia, gwajin ya gano coronavirus a cikin mutane 11 masu asymptomatic, kuma 10 daga cikin waɗannan mutane sun gwada inganci ta PCR.A watan Fabrairu, gwamnatin Amurka ta ba da sanarwar cewa za ta sayi gwaje-gwaje miliyan 8.5.
Wasu ƙasashe/yankunan da ba su da isassun albarkatu don gwajin PCR, kamar Indiya, sun yi amfani da gwajin antigen tsawon watanni da yawa, kawai don ƙara ƙarfin gwajin su.Daga cikin damuwa ga daidaito, wasu kamfanonin da ke yin gwajin PCR kawai sun fara gabatar da hanyoyin gaggawa zuwa iyakacin iyaka.Amma gwamnatin da ta aiwatar da manyan gwaje-gwaje cikin sauri ta kira nasara.Slovakia mai yawan jama'a miliyan 5.5 ita ce kasa ta farko da ta yi kokarin gwada daukacin al'ummarta.Gwaji mai yawa ya rage yawan kamuwa da cuta da kusan 60%5.Koyaya, ana yin gwajin tare da tsauraran matakan hana aiwatarwa a wasu ƙasashe da tallafin kuɗi na gwamnati ga mutanen da suka gwada inganci don taimaka musu su zauna a gida.Saboda haka, masana sun ce ko da yake haɗuwa da gwaji da ƙuntatawa yana nuna yana rage yawan kamuwa da cuta da sauri fiye da ƙuntatawa kadai, ba a bayyana ko hanyar za ta iya aiki a wani wuri ba.A wasu ƙasashe, mutane da yawa ƙila ba sa son yin gwajin cikin sauri, kuma waɗanda suka gwada inganci na iya rasa kwarin gwiwa don ware.Koyaya, saboda gwajin saurin kasuwanci yana da arha-dala 5-Mina kawai ya ce birane da jihohi na iya siyan miliyoyi a wani kaso na asarar gwamnati da annobar ta haifar.
Wani ma’aikacin lafiya yayi gaggawar gwada wani fasinja da hanci a tashar jirgin kasa da ke Mumbai a Indiya.Hoton hoto: Punit Parajpe / AFP / Getty Images
Gwaje-gwajen gaggawa na iya dacewa musamman ga yanayin tantancewar asymptomatic ciki har da gidajen yari, matsugunan marasa gida, makarantu da jami'o'i, inda mutane za su iya taruwa ta wata hanya, don haka duk gwajin da zai iya kama wasu ƙarin kamuwa da cuta yana da amfani.Amma Deeks ya yi taka tsantsan game da yin amfani da gwajin ta hanyar da za ta iya canza halayen mutane ko kuma ta sa su sassauta matakan kiyayewa.Misali, mutane na iya fassara sakamako mara kyau azaman ziyarar ƙarfafawa ga dangi a gidajen kulawa.
Ya zuwa yanzu, a Amurka, an kaddamar da manyan hanyoyin gwaji cikin sauri a makarantu, gidajen yari, filayen jiragen sama da jami'o'i.Misali, tun watan Mayu, Jami'ar Arizona da ke Tucson ke amfani da gwajin Sofia da Quidel ya kirkira a San Diego, California don gwada 'yan wasanta a kullun.Tun daga watan Agusta, ta kan gwada dalibai akalla sau daya a wata (wasu dalibai, musamman wadanda ke dakunan kwanan dalibai masu fama da barkewar cutar, ana gwada su akai-akai, sau ɗaya a mako).Ya zuwa yanzu, jami'ar ta yi gwaje-gwaje kusan 150,000 kuma ba ta ba da rahoton karuwar cutar ta COVID-19 ba a cikin watanni biyu da suka gabata.
David Harris, wani mai binciken kwayar halitta mai kula da babban shirin gwaji na Arizona, ya ce nau'ikan gwaje-gwaje daban-daban suna amfani da dalilai daban-daban: bai kamata a yi amfani da gwajin saurin antigen ba don tantance yawan ƙwayar cuta a cikin jama'a.Ya ce: "Idan kun yi amfani da shi kamar PCR, za ku sami mummunan hankali.""Amma abin da muke ƙoƙarin yi - hana yaduwar cutar-antigen gwajin, musamman idan aka yi amfani da shi sau da yawa, da alama yana aiki da kyau.”
Wani dalibi daga Jami'ar Oxford da ke Burtaniya ya yi gwajin maganin antigen cikin sauri da jami'ar ta bayar sannan ya tashi zuwa Amurka a watan Disamba 2020.
Kungiyoyin bincike da yawa a duniya suna tsara hanyoyin gwaji cikin sauri da rahusa.Wasu suna daidaita gwaje-gwajen PCR don haɓaka aikin haɓakawa, amma yawancin waɗannan gwaje-gwajen har yanzu suna buƙatar kayan aiki na musamman.Sauran hanyoyin sun dogara da wata dabara da ake kira madauki-matsakaici isothermal amplification ko LAMP, wanda ya fi PCR sauri kuma yana buƙatar kayan aiki kaɗan.Amma waɗannan gwaje-gwajen ba su da mahimmanci kamar gwajin tushen PCR.A bara, masu bincike a Jami'ar Illinois a Urbana-Champaign sun ɓullo da nasu gwajin gwaji mai sauri: gwajin PCR wanda ke amfani da miya maimakon swab na hanci, yana tsallake matakai masu tsada da jinkiri.Farashin wannan gwajin shine $10-14, kuma ana iya bayar da sakamako cikin ƙasa da sa'o'i 24.Kodayake jami'a ta dogara da dakunan gwaje-gwaje na kan layi don yin PCR, jami'ar na iya tantance kowa sau biyu a mako.A cikin watan Agustan shekarar da ta gabata, wannan shirin na gwaji akai-akai ya baiwa jami'ar damar gano yawan kamuwa da cututtukan da ke cikin harabar jami'ar da kuma shawo kan ta sosai.A cikin mako guda, adadin sabbin cututtukan ya ragu da kashi 65%, kuma tun daga lokacin, jami'a ba ta ga kololuwar irin wannan ba.
Boehme ya ce babu wata hanyar gwaji da za ta iya biyan dukkan bukatu, amma hanyar gwajin da za ta iya gano masu kamuwa da cutar na da matukar muhimmanci wajen bude tattalin arzikin duniya.Ta ce: "Gwaji a filayen jirgin sama, kan iyakoki, wuraren aiki, makarantu, saitunan asibiti - a duk waɗannan lamuran, gwaje-gwaje masu sauri suna da ƙarfi saboda suna da sauƙin amfani, ƙarancin farashi, da sauri."Koyaya, ta kara da cewa, manyan shirye-shiryen gwaji yakamata su dogara da mafi kyawun gwaje-gwajen da ake samu.
Tsarin amincewar EU na yanzu don gwajin gwajin COVID-19 iri ɗaya ne da sauran nau'ikan hanyoyin bincike, amma damuwa game da aiwatar da wasu hanyoyin gwaji ya haifar da gabatar da sabbin ƙa'idodi a watan Afrilun da ya gabata.Waɗannan suna buƙatar masana'antun su samar da kayan gwaji waɗanda za su iya aƙalla yin gwajin COVID-19 a sabuwar yanayin fasaha.Koyaya, tunda tasirin gwajin da aka yi a cikin gwajin masana'anta na iya bambanta da na a zahiri, ƙa'idodin sun ba da shawarar cewa ƙasashe membobin su tabbatar da shi kafin ƙaddamar da gwajin.
Boehme ya ce, a zahiri, kasashe ba za su tabbatar da kowace hanyar aunawa ba.Dakunan gwaje-gwaje da masana'antun a duk duniya za su yi amfani da ka'idoji gama gari (kamar waɗanda FIND ta haɓaka).Ta ce: "Abin da muke bukata shine daidaitaccen gwaji da hanyar tantancewa.""Ba zai bambanta da kimanta jiyya da alluran rigakafi ba."


Lokacin aikawa: Maris-09-2021