Gwajin COVID-19 Cikin Saurin Antigen

ąąąGwajin saurin antigen, na COVID-19, wanda kuma akai-akai ake kira COVID-19 gwaje-gwajen kwarara ta gefe,gwaje-gwajen saurin antigen ne da ake amfani da su don gano kamuwa da cutar SARS-COV-2 (COVID-19 ). Suna saurin aiwatarwa tare da ƙaramin horo, suna ba da fa'idodin tsada, farashi kaɗan na sauran nau'ikan gwajin COVID-19 kuma suna ba masu amfani sakamako a cikin mintuna 5-30. Ana amfani da gwaje-gwajen antigen cikin sauri a cikin ƙasashe da yawa a zaman wani ɓangare na gwajin taro ko hanyoyin tantance yawan jama'a.[1][2][3] Ana tsammanin suna da mahimmanci don gano mutanen da ke da asymptomatic kuma suna iya yada cutar zuwa wasu mutane, waɗanda ba za su san sun kamu da cutar ba.[4] Wannan ya bambanta da sauran nau'ikan gwaji na COVID-19, kamar PCR, waɗanda galibi ana ganin su zama gwaji mai amfani ga mutane masu alama, saboda suna da haɓakar hankali kuma suna iya gano lokuta daidai.

Gwajin COVID-19 Cikin Saurin Antigen
Bayanai
Ƙaramin ɓangare na COVID-19 test (en) Fassara, lateral flow test (en) Fassara da rapid antigen test (en) Fassara
cutar Covid 19
Cutar korona
Rigakafin korona

Tarihin ci gaban fasahar gwaji na saurin COVID-19

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Gwajin gaggawa na Covid-19 a Rwanda

Gwaje-gwaje masu sauri don COVID-19 sun fito daga manyan saka hannun jari ta shirin Burtaniya Moonshot mai rikitarwa, shirin £ 100 biliyan don tantance tsari, haɓakawa da aiwatar da sabbin fasahohi don gwajin COVID-19.[5] Rapid gwaje-gwaje da farko zauna a cikin wannan din kimantawa bututun dab da yawa wasu putative COVID-19 gwaji da fasahohi kamar fitila, Lampore, batu na kula PCR, taro spectrometry da samfurin pooling. Koyaya, yayin da aka ci gaba da kimantawa, gwaje-gwaje masu sauri sun fito a matsayin mafi nasara nau'in gwajin COVID-19 a cikin wannan shirin don dacewa da gwajin PCR na yanzu.[ana buƙatar hujja]

Jagorar kasa da kasa don amfani da fasahar gwajin saurin COVID-19 da haɓakawa

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Dalilin farko na kimiyya don yuwuwar amfani da gwaje-gwaje cikin sauri da jagorar duniya don haɓaka fasahar gwaji cikin sauri an haɓaka ta hanyar jagorar wucin gadi daga WHO wacce ta nuna fa'idodin da za a iya samu.[6] Rahoton ya lura cewa gwaje-gwajen gaggawa sun fi sauƙin aiwatarwa, kuma suna da fa'idodi masu tsada. Hukumar ta WHO ta ba da shawarar amfani da su wajen barkewar cutar, don gano cutar da wuri da kuma sa ido kan yanayin cututtuka. Daga baya, kuma daga baya ga ƙungiyar nazarin da ke ƙaruwa da sauri, wannan shawarar ta fadada ta Hukumar Turai. Hukumar Tarayyar Turai ta ba da shawarar yin amfani da fasahar gwaji cikin sauri don tantance yawan jama'a inda adadin ingancin gwajin ya yi girma ko kuma ya yi yawa.[7] Ya zuwa Janairu 2021, Hukumar Tarayyar Turai ta amince da karfafa matsayinsu, tana ba da shawarar yin amfani da gwaje-gwaje cikin sauri, lura da cewa "ya kamata bincike ya tabbatar da cewa gwajin antigen mai sauri na iya gudanar da gwajin da kansu .... Gwajin kai tare da ko ba tare da jagorar kwararru ba. kuma za a iya la'akari."[8]

Karatun Farko

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Ofaya daga cikin ingantaccen binciken don gwaje-gwaje cikin sauri an kammala ta Lafiyar Jama'a Ingila, Jami'ar Oxford da Jami'ar Manchester, kuma Farfesa Richard Body da Dr Lennard Lee suka ƙaddamar. An kaddamar da binciken Falcon-C19 a cikin kwanaki uku a ranar 17 ga Satumba. An dauki majiyyaci na farko a filin wasa na Manchester City Etihad carpark a sabuwar cibiyar gwajin COVID-19. Binciken ya haɓaka cikin sauri har ya haɗa da wuraren bincike na al'umma 14 a duk faɗin Burtaniya. An rufe binciken ne a ranar 23 ga Oktoba, bayan kammala gwajin mutane 878. Binciken ya kasance ɗaya daga cikin binciken bincike na COVID-19 mafi sauri a Burtaniya a cikin ƙasar. Binciken ya ba da tabbataccen shaida cewa na'urorin gwaji masu sauri sun iya ɗaukar sakamako mai kyau tare da daidaito mai girma. Jimlar gwaje-gwaje masu sauri guda 4, gami da Innova SARS-CoV-2 Antigen Rapid Qualitative Test da Orientgene COVID-19 IgG/IgM Rapid Test Cassette, an inganta su a cikin wannan binciken, ta amfani da samfuran swab daga duka alamomi da masu asymptomatic.[9]

A daidai lokacin da ake fitar da bincike na wucin gadi na wannan binciken na Burtaniya, Amurka ta tabbatar da cewa za a sayi gwaje-gwajen gaggawa miliyan 100 daga Abbott kuma za a tura su a duk fadin kasar don fara irin wannan karatun na Amurka, don kammala karatun da Jami'ar Oxford ta fara.[10]

Nazarin ƙima a duk faɗin duniya

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A ranar 2 ga Nuwamba, 2020, Slovakia ta zama ƙasa ta farko a duniya da ta fara gwajin yawan jama'a ta hanyar amfani da gwaje-gwaje cikin sauri. Ma’aikata 60,000 ne suka yi gwaje-gwaje cikin sauri miliyan biyar waɗanda suka yi amfani da gwajin antigen SD Biosensor kuma suka yi swabbing a kan jama'a.[11][12] Wannan ya sa Hukumar Tarayyar Turai ta ba da shawarar a yi amfani da gwaje-gwaje cikin sauri a matsayin wani ɓangare na tantance yawan jama'a.[1] Nazarin bincike guda biyu da aka buga a farkon 2021, ɗaya daga farfesa Martin Kahanec daga Jami'ar Turai ta Tsakiya da mawallafinsa da kuma wani na Martin Pavelka daga Makarantar Tsabtace & Magungunan Tropical na London da ƙungiyarsa sun ba da shawarar cewa tasirin guguwar kaka na saurin antigen. gwajin da aka yi a Slovakia ya taimaka wajen dakile barkewar cutar a kasar, kodayake a cewar tsohon binciken sakamakon gwajin yawan jama'a kan cutar na wucin gadi ne kuma ya fara bazuwa bayan kimanin makonni biyu.[13][14]

Burtaniya ta ci gaba da ci gaba da shirin ci gaban gwaji cikin sauri ta hanyar amfani da gwajin sauri na Innova, tare da haɓaka cikin gaggawa yayin da shari'o'in COVID-19 ke ƙaruwa a duk faɗin Turai. A ranar 6 ga Nuwamba, Firayim Minista, Boris Johnson ya fara aikin tantance Liverpool a duk faɗin birni a matsayin wani ɓangare na haɓakar fasahar fasaha.[15] An kuma ƙaddamar da ƙarin fadada matukan gwaje-gwaje masu sauri a sassa da yawa waɗanda ba a taɓa yin gwajin ba. Wadannan sun hada da dalibai a Jami'o'in da suka yi fama da barkewar cutar. Wannan da farko ya fara ne a Jami'ar Durham wanda ke da abubuwan more rayuwa da ƙwarewa don gudanar da shirin gwaji cikin sauri,[16] amma an faɗaɗa yawancin Jami'o'in Burtaniya kuma ya ba da damar tsarin ƙaura na ƙasa don samun ɗalibai a gida lafiya don Kirsimeti.[17] An kuma aiwatar da gwaje-gwaje cikin sauri a cikin Ma'aikatar Kiwon Lafiya ta Kasa don ma'aikata don rage yiwuwar watsawa ga marasa lafiya,[18] ƙananan hukumomi[19][20] da gidajen kulawa don ba da damar ziyartar mazauna.[21][22] A ranar 18 ga Nuwamba 2020, Wales ta kammala gwajin gabaɗayan gundumar farko a Merthyr Tydfil.[23][24] A wannan lokacin, an kuma aiwatar da gwaji a duk makarantu a cikin Amurka don ɗalibai masu alamun cutar[25] da kuma cikin gidajen kulawa na Portuguese da makarantu.[26]

Sashen gaggawa na Hukumar Lafiya ta Duniya (WHO) ne ya ƙaddamar da ƙoƙarin duniya don haɓaka kimanta gwaje-gwaje cikin sauri wanda ya ƙaddamar da babban aikin aiwatar da gwajin cutar cikin sauri a ranar 10 ga Nuwamba, tare da taimakon yarjejeniya daga gidauniyar Bill da Melinda Gates wanda ke iyakance farashin don Kasashe masu karamin karfi da matsakaicin kudin shiga.[27][28]

Austria ta fara gwajin jama'a a fadin kasar a ranar 5 ga Disamba kuma ta ba da umarnin gwaje-gwaje miliyan bakwai da suka kunshi gwajin SD Biosensor da Siemens Clinitest (aka Orientgene).[29][30]

A tsakiyar watan Disamba, an yi nazari da yawa da ke tabbatar da inganci da nasarar amfani da gwaje-gwaje masu sauri don gano mutane da COVID-19 ciki har da karatu a cikin Netherlands,[31] United Kingdom,[32] da Amurka.[33] Waɗannan karatun duk sun ba da damar gwaje-gwaje masu sauri don shiga daidaitattun dabarun gwajin COVID-19 na ƙasa. Gwajin gwaje-gwajen gaggawa na duniya yanzu ya zama ruwan dare gama gari a makarantu a Kanada,[34] wuraren balaguro a Indonesia,[35] da kuma cikin Indiya.[36]

Damuwa game da amfani

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Mutane da yawa sun tayar da damuwar cewa daidaiton gwaje-gwaje masu sauri ba su da kyau kamar yadda ake yin gwajin COVID-19 na PCR. Bayanan da aka fitar daga allon babban birni na Burtaniya a Liverpool sun nuna cewa sojojin da suka yi gwajin gwajin sun sami aikin gwajin kwararrun masana kimiyyar dakin gwaje-gwaje,[37] bin wasu matukan jirgi a Indiya.[38] Wannan ya haifar da ƙananan batutuwa a cikin al'ummar kimiyya-psychological inda aka yi muhawara game da ko gwaje-gwaje masu sauri na iya haifar da tabbatacciyar ƙarya da canji a ɗabi'a. Koyaya, an tabbatar da canjin tunani game da amfani da gwaje-gwaje masu sauri bayan buga daga Amurka. Farfesa Michael Mina ya yi hasashen cewa har yanzu gwaje-gwaje masu sauri za su kasance da amfani yayin da aka gano masu kamuwa da cuta,[39] da fa'idodin da aka samu daga maimaita gwajin sauri da samun sakamako cikin sauri fiye da sauran nau'ikan gwaji.[40][41] Babbar jami'ar kula da lafiya ta Burtaniya, Dokta Susan Hopkins, ta kuma lura cewa gwaje-gwaje masu sauri sun samar da hanyar gano "mutanen da ... ba za mu iya samu ba".[42]

Da yake lura da ikon gano lamura cikin sauri, da kuma la'akari da ci gaba da tabarbarewar lamura a Turai, hukumar ta Tarayyar Turai ta gana a ranar 11 ga Disamba kuma ta samar da tsarin gama gari na Turai don "amfani, tabbatarwa da fahimtar juna na gwaje-gwaje masu sauri", da aiwatar da Yuro miliyan 100 don siyan gwaje-gwaje daga Roche da Abbott . Stella Kyriakides, kwamishiniyar Lafiya da Kariyar Abinci ta ce "Gwajin maganin antigen cikin sauri yana ba mu sauri, dogaro da martani mai sauri don ware lokuta na COVID. Wannan yana da mahimmanci don rage yaduwar cutar."[43]

Wasu mutane sun nuna damuwa game da jinkirin ɗaukar nauyi da jigilar gwaje-gwaje cikin sauri da yuwuwar asarar rayuka da ka iya faruwa a sakamakon. Wata ƙungiyar ilimi daga Kanada ta lura cewa rabin mace-mace a gidajen kulawa a farkon farkon cutar za a iya hana su ta hanyar gwaje-gwaje cikin sauri.[44]

Amincewa da tsarin duniya don amfani don gwajin COVID-19

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Bayan nasarar binciken da yawa a duk duniya don nazarin gwaje-gwaje masu sauri daga watan Agustan 2020, ƙungiyoyin da ke da tsari a duk faɗin duniya sun amince da gwaje-gwaje masu sauri a matsayin wani ɓangare na dabarun amfani da gwaji a matsayin "sabuwar hanyar magance cutar". A ranar 16 ga Disamba, FDA ta zama hukuma ta farko don amincewa da gwajin saurin Abbott.[45] An ba da izini na gaba don gwajin gida na Ellume COVID-19.[46]

Health Canada kuma ta amince da gwaje-gwajen gaggawa tare da mai ba su shawara, Farfesa David Juncter tare da lura da "mafi kyawun gwaje-gwaje masu sauri suna da inganci sosai wajen gano masu kamuwa da cuta" kuma kwararre kan cututtukan cututtuka Jean Longtin yana mai cewa "Zai ba mu damar yin sauri fiye da kwayar cutar kuma mu nemo cutar. tuntuɓar mutum a cikin awa ɗaya ko biyu, maimakon jira awa 24".[47][48]

MHRA ta Burtaniya ta tabbatar da amincewarsu da gwajin gaggawar Innova don gwajin amfani da kai a ranar 23 ga Disamba. Bayan nasarar da aka samu a duniya na wannan ci gaba na gwaje-gwajen gaggawa na duniya, Sir John Bell, Farfesa Regius a fannin likitanci a Jami'ar Oxford ya ce "Gwajin da sauri ya kasance babban abin kariya daga cutar sankara saboda suna da sauri, arha kuma ana samun su don maimaita amfani da su.[37] A cikin watan Yuni 2021, Hukumar Abinci da Magunguna a Amurka ta ba da sanarwar Tunawa da Class 1 na Innova LFT saboda rashin daidaiton su.[49]

Gwaje-gwaje masu sauri a matsayin "komawa ga al'ada"

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Spain ta zama ƙasa ta farko da ta yi amfani da gwaje-gwaje cikin sauri don sauƙaƙe komawa zuwa al'ada tare da gwaje-gwajen gaggawa da ake samu a cikin kantin magani,[50] da kuma wasan kide-kide na kiɗan kyauta da aka gudanar a Barcelona ga mutanen da suka yi gwajin sauri.[51] An ɗauki irin wannan hanya a Albaniya don ba da damar bukukuwan kiɗa.[52] Koyaya, ƙwararrun masana da yawa ba su da tabbas game da wannan hanyar suna gaskanta cewa "gwajin gaggawa ba shine mafita don sake farawa rayuwa ta al'ada ba"[53] amma ana iya amfani dashi tare da wasu mahimman matakan rigakafin kamuwa da cuta kamar sa PPE mai dacewa, wanke hannu akai-akai da zamantakewa. nisantar ba da damar mutane su sami wannan muhimmin lokacin tare da waɗanda suke ƙauna yayin da suke taimakawa don kiyaye su.[54]

Sabbin nau'ikan COVID-19

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A ranar 22 ga Disamba, 2020, an gano wani sabon nau'in cutar SARS-CoV-2 a cikin Burtaniya, VOC-202012/01 . Nauyin ya bazu cikin sauri a duniya. Tare da yaɗuwar amfani da wannan nau'i na gwajin COVID-19 a duniya, akwai damuwa cewa wannan bambance-bambancen zai sa gwajin sauri ya ƙare. A matsayin wani ɓangare na haɓaka fasahar fasahar Burtaniya ta haɓaka kwararar ruwa, a cikin sa'o'i 24, dakunan gwaje-gwajen Kiwon Lafiyar Jama'a na Ingila sun sami damar tabbatar da gwajin saurin ci gaban duniya bai shafa ba kuma suna iya gano sabon bambance-bambancen. Wannan saboda saurin gwajin gabaɗaya yana hari akan furotin nucleocapsid ne ba furotin mai karu ba.[55] Wasu nau'ikan ko da yake, kwanan nan an gano su waɗanda ke shafar wasu saurin gwaji har zuwa ninki 1000.[56] Abin farin ciki, yawan waɗannan maye gurbi na nucleocapsid (musamman D399N) har yanzu yana da ƙarancin ƙarancin duniya a ~ 0.02%.

Amfanin ɗan adam don gwaje-gwaje masu sauri

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Baya ga amfani da al'umma na yau da kullun, an kuma yi amfani da gwaje-gwaje cikin sauri a matsayin wani ɓangare na ƙoƙarin jin kai yayin bala'in. Bayan ambaliya a Jakarta a Indonesia a ranar 2 ga Disamba, an yi gwajin gaggawa a matsugunan ambaliyar ruwa.[57] Bugu da kari, bayan rufe iyakokin kasa a Turai biyo bayan bullar sabuwar matsalar Burtaniya kafin Kirsimeti, direbobin manyan motoci kusan 6,000 ne suka makale ba tare da abinci ba,[58] sun dakatar da isar da abincin Kirsimeti yadda ya kamata. Ma'aikatan kashe gobara na Faransa ne suka yi gwajin gaggawa cikin sa'o'i 24 a tashar. Gwaje-gwajen gaggawa sun baiwa manyan motocin dakon kaya damar hawa kan hanya da kammala jigilar kayayyaki da komawa ga iyalansu don Kirsimeti, yana nuna yuwuwar amfanin duniya na samun gwajin COVID-19 mai sauƙin aiwatarwa.[59][60] Kungiyar likitoci ta Médecins Sans Frontières ta amince da yin amfani da gwaje-gwaje cikin sauri a cikin kasashe masu karamin karfi da matsakaicin kudin shiga, tare da lura da cewa "Gwajin antigen na COVID-19 na iya ba da sakamako cikin sauri da aiki, tare da tabbatar da gano mutanen da suka kamu da kwayar cutar a matakin al'umma".[61]

Amurka da gwaje-gwaje masu sauri

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Bayan da aka fara saka hannun jari mai yawa a cikin saurin haɓaka fasahar gwaji tare da Burtaniya, ƙarin kimanta gwaje-gwajen cikin sauri a matsayin wani ɓangare na hanyoyin gwajin yawan jama'a a Amurka ya tsaya cik sakamakon rikicin kusan dala biliyan 900 na agajin COVID-19 da ke ƙunshe a cikin Haɗin gwiwar 2020 Dokar Kasafin Kudi, 2021 . An soki dokar saboda ba musamman saka hannun jari na zobe a cikin gwaje-gwaje masu sauri a matsayin tsada-tattalin arziki da ingantaccen nau'i na gwajin yawan jama'a.[62] Masana kimiyya a Amurka, irin su Farfesa Michael Mina na Jami'ar Harvard, sun lura cewa gwaje-gwajen sun kasance "masu ƙarfi sosai ga duk abin da mutane ke yi" kuma "gwajin gida don COVID-19 na iya rage yawan kamuwa da cuta".[63] Farfesa William A. Haseltine, shi ma na Harvard, ya ƙarfafa wannan ra'ayi, a cikin wata kasida a cikin mujallar Forbes da ke ba da shawara "Gwajin da za a yi cikin gaggawa, zai iya dakatar da yaduwar cututtuka da mutuwa"[64] da kuma labarin da Farfesa Annie ya yi. Sparrow na Dutsen Sinai, New York yana ba da shawarar "Gwajin Rahusa Yana da Muhimmanci ga Nasara ta Cutar Kwalara" bisa la'akari da "gaggawa na nau'in B117 mai saurin yaduwa da sauri a cikin Burtaniya, da irin wannan nau'in daga Afirka ta Kudu".[65] Koyaya, saurin gwajin gida don COVID-19 yana samuwa ga mutane a bainar jama'a a cikin Janairu 2021, bin amincewar FDA ta farko.[66][67] Masu ba da inshorar lafiya a Amurka sun biya waɗannan gwaje-gwajen ga mutanen da ke da alamun COVID-19, ko waɗanda ke da kusanci da mai kamuwa da cuta ko tare da wani da ke nuna alamun.[68] Wani labarin a cikin Washington Post ya ba da shawarar cewa mafi girman fa'idar gwaje-gwaje cikin sauri a cikin Amurka ba za a iya cimmawa ba har sai "gwamnatin tarayya ta rufe gwajin mutanen da ba su da lafiya saboda watsar da wadancan mutanen babban bangare ne na barkewar", yayin da ake gwada wadannan mutane. inshorar lafiya bai rufe shi ba.[69][67] Bayan zaben sabon shugaban kasa a watan Janairun 2021, Amurka ta sake fara saka hannun jari a cikin saurin bunkasa fasahar fasahar tare da buga umarnin zartarwa na shugaban kasa.[70][71]

Darajar kasuwar duniya

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Bayan yawaitar amfani da gwaje-gwaje cikin sauri a duk duniya, gwaje-gwaje masu sauri suna da darajar kasuwa ta dala biliyan 15; duk da haka, ana sa ran kasuwar za ta daina daga 2024 saboda allurar rigakafin yawan jama'ar duniya a ƙarshen 2023.[72] A cikin Amurka, kasuwa don saurin gwaje-gwaje shine dalar Amurka biliyan 3.9 tare da ƙimar haɓaka> 20% a asibitoci, asibitoci, Asiya Pacific amma kuma azaman gwajin masu amfani.[73] Manazarta kasuwannin kasa da kasa sun yi hasashen cewa masu kera gwaje-gwaje cikin sauri za su fuskanci karuwar bukatu yayin da mutane da yawa suka fara amfani da gwaje-gwaje cikin sauri don gano mutanen da ke da alamun sauki.[74] Yawancin masu sharhi da masana kimiyya daga Amurka sun nuna damuwa ko cibiyar sadarwa ta duniya ta sami damar biyan bukatun duniya tare da kera daruruwan miliyoyin gwaje-gwajen da za a buƙaci don gwaji akai-akai.[75][76]

Manazarta

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