Ukusebenza kwezivavanyo ezine ze-nucleic acid amplification ukuchonga i-SARS-CoV-2 e-Ethiopia

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Ukusukela oko kwaqhambuka isifo se-coronavirus (COVID-19) sika-2019, iimvavanyo ezininzi zokurhweba ze-nucleic acid amplification (NAATs) ziye zaphuhliswa kwihlabathi jikelele kwaye ziye zaba luvavanyo oluqhelekileyo.Nangona iimvavanyo ezininzi zaphuhliswa ngokukhawuleza kwaye zasetyenziswa kwiimvavanyo zokuxilongwa kwebhubhoratri, ukusebenza kwezi mvavanyo akuzange kuvavanywe kwiindawo ezahlukeneyo.Ke ngoko, olu phononongo lujolise ekuvavanyeni ukusebenza kwe-Abbott SARS-CoV-2, i-Daan Gene, i-BGI, kunye ne-Sansure Biotech assays kusetyenziswa uMgangatho weReference Composite (CRS).Uphononongo lwenziwe kwi-Ethiopian Public Health Institute (EPHI) ukusuka kwi-1 ukuya kwi-30 kaDisemba 2020. Iisampulu ze-164 ze-nasopharyngeal zikhutshwe kusetyenziswa i-QIAamp RNA mini kit kunye nenkqubo yokulungiselela isampula ye-Abbott DNA.Kwimizekelo ye-164, i-59.1% yayilungile kwaye i-40.9% yayingenayo i-CRS. I-Sansure Biotech positivity yayiphantsi kakhulu xa ithelekiswa ne-CRS (p <0.05). I-Sansure Biotech positivity yayiphantsi kakhulu xa ithelekiswa ne-CRS (p <0.05). Положительные результаты Sansure Biotech были значительно ниже по сравнению с CRS (p <0,05). Iziphumo ezilungileyo ze-Sansure Biotech zazisezantsi kakhulu xa kuthelekiswa ne-CRS (p <0.05).Imveliso yeCRS 相比，Sansure Biotech 的阳性率显着较低（p <0.05）.Imveliso yeCRS 相比，Sansure Biotech 的阳性率显着较低（p <0.05）. У Sansure Biotech было значительно меньше положительных результатов по сравнению с CRS (p <0,05). I-Sansure Biotech ineziphumo ezilungileyo ezimbalwa kakhulu xa kuthelekiswa ne-CRS (p <0.05).Imvumelwano iyonke yohlalutyo olune yayiyi-96.3-100% xa kuthelekiswa ne-CRS.Ukongeza kwizinga eliphantsi lepositivity yovavanyo lweSansure Biotech, ukusebenza kwezi mvavanyo zine phantse kuthelekiseka.Ngaloo ndlela, uvavanyo lwe-Sansure Biotech [uPhando Kuphela (RUO)] lufuna ukuqinisekiswa okongeziweyo kokusetyenziswa kwayo e-Ethiopia.Okokugqibela, uphando olongezelelweyo kufuneka luqwalaselwe ukuvavanya iimvavanyo kunye namabango afanelekileyo omenzi.
Uvavanyo lwaselabhoratri yinxalenye yeSicwangciso soBuchule soMbutho wezeMpilo weHlabathi (i-WHO) seSifo se-Coronavirus sowama-2019 (COVID-19) sokuLungiselela nokuSabela (SPRP).I-WHO icebisa ukuba amazwe kufuneka akhe amandla ebhubhoratri ukuphucula ukulungela, ulawulo olufanelekileyo lwamatyala, ukuqapha kunye nokuphendula ngokukhawuleza kwimingeni yempilo yoluntu.Oku kuphakamisa ukuba indima yelabhoratri ingundoqo ekuphawuleni isifo kunye ne-epidemiology yee-agents ezivelayo ezosulelayo kunye nokulawula ukusasazeka kwazo.
Ukufunyaniswa kwe-COVID-19 kufuna ulwazi lwe-epidemiological kunye nezonyango, iimpawu zomntu/iimpawu, kunye nedatha yeradiographic kunye nelabhoratri2.Ukusukela oko kwaxelwa ukuqhambuka kwe-COVID-19 e-Wuhan, e-China, iimvavanyo ezininzi zokurhweba ze-nucleic acid amplification (NAATs) ziye zaphuhliswa kwihlabathi jikelele.Ixesha lokwenyani loshicilelo lwe-polymerase chain reaction (rRT-PCR) lusetyenziswe njengesiqhelo kunye nendlela eqhelekileyo yokuxilongwa kwelebhu ye-acute acute breathing syndrome 2 (SARS-CoV-2)3 usulelo.Ukufunyanwa kwemolekyuli ye-SARS-CoV-2 ngokwesiqhelo isekwe kwi-N (nucleocapsid protein gene), E (invelope protein gene), kunye ne-RdRp (i-RNA-dependent RNA polymerase gene) kwi-ORF1a/b (ifreyimu yokufunda evulekileyo 1a/b) .gene) indawo echongwe kwijenome yentsholongwane.Zithathwa njengezona ngingqi zigciniweyo ezifumaneka kwiijenomes zentsholongwane ekwaziwa4.Phakathi kwezi jini, i-RdRp kunye ne-E yemfuza inovakalelo oluphezulu lokufumanisa uhlalutyo, ngelixa i-N gene ine-analytical sensitivity5.
Ukusebenza kwee-assays ze-PCR kunokwahluka ngokuxhomekeka kwizinto ezahlukeneyo ezifana: i-reagents extraction, i-amplification / reagents yokubona, indlela yokukhupha, umgangatho womatshini we-PCR kunye nezinye izixhobo.Ukusukela ngo-Epreli ka-2020, ngaphezulu kwe-48 yezixhobo ezahlukeneyo zokuxilonga ezivela kumazwe alithoba zifumene uGunyaziso lokuSebenzisa oluNgxamisekileyo (EUA) kuxilongo lwe-COVID-196.E-Ethiopia, ngaphezu kwe-14 iiplatifti ze-PCR zexesha lokwenyani zisetyenziselwa ukuchongwa kwe-PCR ye-SARS-CoV-2 kumaziko ezempilo oluntu angama-26, kubandakanya i-ABI 7500, i-Abbott m2000, i-Roche 48000 kunye ne-Quant-studio7.Ukongeza, iikiti ezahlukeneyo zovavanyo lwe-PCR ziyafumaneka, ezinje ngovavanyo lwe-Daan Gene, uvavanyo lwe-Abbott SARS-CoV-2, uvavanyo lwe-Sansure Biotech, kunye novavanyo lwe-SARS-CoV-2 BGI.Nangona i-rRT-PCR inovakalelo oluphezulu, ezinye izigulana ezine-COVID-19 zixela iziphumo ezingezizo ezingeyonyani ngenxa yokungonelanga kweekopi ze-viral ribonucleic acid (RNA) kwiisampulu ngenxa yokuqokelelwa ngokungafanelekanga, ukuthuthwa, ukugcinwa kunye nokuphathwa, kunye novavanyo lwaselabhoratri.iimeko kunye nezenzo zabasebenzi8.Ukongeza, iisampulu okanye ukulawula ukuphathwa kakubi, ukusetwa komjikelo (Ct), kunye ne-cross-reactivity kunye nezinye i-pathogenic nucleic acids okanye i-SARS-CoV-2 RNA engasebenziyo/eshiyekileyo inokukhokelela kwiziphumo ezingezizo zobuxoki kwiimvavanyo ze-rRT-PCR9.Ngaloo ndlela, kuyacaca ukuba iimvavanyo ze-PCR ngokwenene ziyakwazi ukuchonga abathwali bamaqhekeza emfuza, njengoko bengakwazi ukwahlula phakathi kweejeni zentsholongwane esebenzayo ngokwenene, ngoko ke iimvavanyo ziyakwazi ukuchonga abathwali kwaye kungekhona izigulane10.Ngoko ke, kubalulekile ukuvavanya ukusebenza kokuxilonga usebenzisa iindlela eziqhelekileyo kwisimo sethu.Nangona ii-reagents ezininzi ze-NAAT zifumaneka kwi-Ethiopian Public Health Institute (EPHI) nakwilizwe lonke, akukho vavanyo lokuthelekisa ukusebenza kwazo olusele luxeliwe.Ke ngoko, olu phononongo lujolise ekuvavanyeni ukuthelekisa ukusebenza kweekhithi ezifumanekayo kurhwebo ukubhaqwa kwe-SARS-CoV-2 yi-rRT-PCR kusetyenziswa iisampulu zeklinikhi.
Bebonke ngabathathi-nxaxheba abali-164 abarhanelwa ukuba yi-COVID-19 babandakanyiwe kolu phononongo.Uninzi lweesampulu bezivela kumaziko onyango (118/164 = 72%), ngelixa i-46 eseleyo (28%) abathathi-nxaxheba bebesuka kumaziko angengawo unyango.Phakathi kwabathathi-nxaxheba abangaphathwanga kweli ziko, i-15 (9.1%) inamatyala akrokrelekayo ekliniki kwaye ama-31 (18.9%) ayenoqhagamshelwano lwamatyala aqinisekisiweyo.Amashumi alithoba anesithathu (56.7%) abathathi-nxaxheba ibingamadoda, kwaye iminyaka yobudala (± SD) yabathathi-nxaxheba yayiyi-31.10 (± 11.82) iminyaka.
Kolu phononongo, kumiselwe amazinga aqinisekileyo kunye namabi ovavanyo olune lwe-COVID-19.Ke, amaxabiso amahle ovavanyo lwe-Abbott SARS-CoV-2, i-Daan Gene 2019-nCoV assay, i-SARS-CoV-2 BGI assay, kunye ne-Sansure Biotech 2019-nCoV assay yayingama-59.1%, 58.5%, 57.9% kunye ne-55.5% ngokulandelanayo. .Umgangatho wereferensi echanekileyo kunye nembi (CRS) amanqaku ayengama-97 (59.1%) kunye nama-67 (40.9%), ngokulandelanayo (iThebhile 1).Kolu phononongo, inkcazo ye-CRS yayisekwe kumgaqo “wokulungileyo”, apho kwiziphumo zovavanyo ezine, iziphumo zovavanyo ezimbini nangaphezulu ezinike iziphumo ezifanayo zijongwa njengenyani okanye zimbi.
Kule sifundo, sifumene isivumelwano sepesenti esingalunganga (NPA) ye-100% (95% CI 94.6-100) kulo lonke uhlalutyo xa kuthelekiswa ne-CRS.Uhlalutyo lwe-Sansure Biotechnology lubonise i-PPA encinci ye-93.8% (95% CI 87.2-97.1) kunye nohlalutyo lwe-Daan Gene 2019-nCoV lwalunesivumelwano esipheleleyo se-99.4% (95% CI 96.6-99.9).Ngokwahlukileyo, isivumelwano sisonke phakathi kwe-SARS-CoV-2 BGI assay kunye ne-Sansure Biotech 2019-nCoV assay yayingama-98.8% kunye nama-96.3%, ngokulandelelanayo (Itheyibhile 2).
I-Cohen's kappa coefficient yesivumelwano phakathi kwe-CRS kunye ne-Abbott SARS-CoV-2 iziphumo zovavanyo zazingqinelana ngokupheleleyo (K = 1.00).Ngokufanayo, amaxabiso e-kappa kaCohen afunyenwe nguDaan Gene 2019-nCoV, SARS-CoV-2 BGI, kunye neSansure Biotech 2019-nCoV nazo zihambelana ngokupheleleyo neCRS (K ≥ 0.925).Kolu hlalutyo lokuthelekisa, uvavanyo lwe-chi-square (uvavanyo lwe-McNemar) lubonise ukuba iziphumo zovavanyo lwe-Sansure Biotech 2019-nCoV zahluke kakhulu kwiziphumo zeCRS (p = 0.031) (Itheyibhile 2).
Njengoko kubonisiwe kwiFig.I-1 ipesenti yexabiso eliphantsi le-Ct (< 20 Ct) ye-Abbott SARS-CoV-2 assay (idityaniswe i-RdRp kunye ne-N gene) yayingama-87.6% kunye nexabiso le-Ct le-ORF1a/b le-Ct ye-Sansure Biotech 2019-nCoV ibonise ukuba ipesenti yovavanyo olusezantsi Ixabiso le-Ct (<20 Ct) laliyi-50.3% kunye nexabiso eliphezulu le-Ct (36-40 Ct) laliyi-3.2%. I-1 ipesenti yexabiso eliphantsi le-Ct (< 20 Ct) ye-Abbott SARS-CoV-2 assay (idityaniswe i-RdRp kunye ne-N gene) yayingama-87.6% kunye nexabiso le-Ct le-ORF1a/b le-Ct ye-Sansure Biotech 2019-nCoV ibonise ukuba ipesenti yovavanyo olusezantsi Ixabiso le-Ct (<20 Ct) laliyi-50.3% kunye nexabiso eliphezulu le-Ct (36-40 Ct) laliyi-3.2%.Njengoko kubonisiwe kwiFig.1, процент наименьшего значения Ct (< 20 Ct) анализа Abbott SARS-CoV-2 (комбинированный ген RdRp и N) составил 87,6%, а значение Ct гена ORF1a/b анализа Sansure Biotech 2019-nCoV показало что процент низкого значения Ct (< 20 Ct) составлял 50,3%, а высокое значение Ct (36–40 Ct) составляло 3,2%. 1, ipesenti yelona xabiso lisezantsi le-Ct (< 20 Ct) uhlalutyo lwe-Abbott SARS-CoV-2 (ijene edibeneyo ye-RdRp kunye ne-N) yayingama-87.6%, kwaye ixabiso le-Ct le-ORF1a/b lohlalutyo lofuzo lwe-Sansure Biotech 2019-nCoV lubonisiwe. ukuba ipesenti yexabiso eliphantsi le-Ct (< 20 Ct) ibalwa kwi-50.3%, kunye nexabiso eliphezulu le-Ct (36-40 Ct) libalelwa kwi-3.2%.如图1 所示，Abbott SARS-CoV-2 检测（结合RdRp 和N 基因）的最低Ct 值百分比（< 20 Ct潔潔的公義的公物的公牛羊公羊公徒1Ct）為19 OR-Ct 结合RdRp值(< 20 Ct) 的百分比為50.3%，高Ct 值(36–40 Ct) 的百分比為3.2%. Njengoko kubonisiwe kuMfanekiso 1, eyona pesenti yexabiso eliphantsi leCt (< 20 Ct) yovavanyo lwe-Abbott SARS-CoV-2 (indibaniselwano ye-RdRp kunye ne-N gene) yi-87.6%, ixabiso le-ORF1a/b le-Ct yohlobo lwe-Sansure Biotech 2019-nCoV yovavanyo ibonisa iCt 值 ephantsi (< 20 Ct) 的 ipesenti yi 50.3%, 高Ct 值(36–40 Ct) 的 ipesenti yi 3.2%. Как показано на рисунке 2 - Анализ nCoV показал низкий Ct. Njengoko kubonisiwe kuMfanekiso 1, i-Abbott SARS-CoV-2 assay (edibanisa iRdRp kunye ne-N gene) inelona xabiso lisezantsi lepesenti yeCt (<20 Ct) kuma-87.6%, ngelixa ixabiso leCt ye-ORF1a/b gene kwi-Sansure. Uphononongo lwe-Biotech 2019-Uhlalutyo lwe-nCoV lubonise i-Ct ephantsi. Процент значений (< 20 Ct) составил 50,3%, а процент высоких значений Ct (36–40 Ct) составил 3,2%. Ipesenti yamaxabiso (<20 Ct) yayingu-50.3%, kwaye ipesenti yamaxabiso aphezulu e-Ct (36-40 Ct) yayingu-3.2%.Uvavanyo lwe-Abbott SARS-CoV-2 B lurekhode amaxabiso e-Ct ngaphezulu kwama-30. Kwelinye icala, kwi-BGI SARS-CoV-2 i-gene ye-ORF1a/b yayinexabiso eliphezulu le-Ct (> 36 Ct) ipesenti yayiyi-4% (Fig. 1). Kwelinye icala, kwi-BGI SARS-CoV-2 i-gene ye-ORF1a/b yayinexabiso eliphezulu le-Ct (> 36 Ct) ipesenti yayiyi-4% (Fig. 1). С другой стороны, в анализе BGI SARS-CoV-2 ген ORF1a/b имел высокое значение Ct (> 36 Ct), процент которого составлял 4% (рис. 1). Kwelinye icala, kuhlalutyo lwe-BGI SARS-CoV-2 gene ORF1a/b yayinexabiso eliphezulu le-Ct (> 36 Ct), ipesenteji yayo yayingu-4% (Fig. 1).另一方面，在BGI SARS-CoV-2 检测中，ORF1a/b 基因具有高Ct 值（> 36 Ct）的百分比为4%（图1）. Kwelinye icala, ekubhaqweni kwe-BGI SARS-CoV-2, ipesenti ye-ORF1a/b gene enexabiso eliphezulu le-Ct (>36 Ct) yi-4% (Figure 1). С другой стороны, в анализе BGI SARS-CoV-2 процент генов ORF1a/b с высокими значениями Ct (>36 Ct) составил 4% (рис. 1). Kwelinye icala, kuhlalutyo lwe-BGI SARS-CoV-2, ipesenti ye-ORF1a/b yofuzo enamaxabiso aphezulu e-Ct (>36 Ct) yayiyi-4% (umzobo 1).
Kule sifundo, sithathe iisampuli ze-nasopharyngeal ze-164.Kuzo zonke iintlobo zovavanyo, ukwahlukaniswa kwe-RNA kunye nokukhulisa kwenziwa kusetyenziswa iindlela kunye neekiti ezicetyiswa ngabavelisi abafanelekileyo.
Olu phononongo lubonise ukuba uvavanyo luka-Abbott lwe-SARS-CoV-2 lusebenza ngendlela efanayo ne-CRS, nge-100% elungileyo, engalunganga, kunye nekhonkodensi iyonke.Isivumelwano se-kappa sikaCohen yi-1.00, ebonisa isivumelwano esipheleleyo kunye ne-CRS.Uphononongo olufanayo olwenziwe yiDyunivesithi yaseWashington e-US lufumanise ukuba ubuntununtunu bubonke kunye nokucaca kovavanyo lwe-Abbott lwe-SARS-CoV-2 yayingama-93% kunye ne-100%, ngokulandelelanayo, xa kuthelekiswa novavanyo olumiselwe ilebhu (LDA) yeCDC. .11. Inkqubo yokufumanisa i-Abbott SARS-CoV-2 isekwe ekubhaqweni okudityanisiweyo okudityanisiweyo kofuzo lwe-N kunye ne-RdRp, njengoko zombini iigenes zinovakalelo ngakumbi, kuncitshiswa ubuxoki obungalunganga12.Uphononongo eVienna, eOstriya lukwabonise ukuba iisampulu ezinkulu zokutsalwa kunye nokufunyanwa kwemithamo ye-eluent kunciphisa iziphumo zokudityaniswa kunye nokonyuka kokubonakala kakuhle13.Ke, umdlalo ogqibeleleyo ka-Abbott we-SARS-CoV-2 assay unokunxulunyaniswa nenkqubo yokukhangela iqonga ethi kwangaxeshanye ibone ijene ezidityanisiweyo, ikhuphe inani elikhulu leisampulu (0.5 ml), kwaye isebenzise isixa esikhulu se-eluent (40 µl).
Iziphumo zethu zibonise ukuba ukusebenza kovavanyo lwe-Daan yofuzo kwakuphantse kufana ne-CRS.Oku kuhambelana nesifundo14 esiqhutywe kwiYunivesithi yase-Anhui e-Huainan, e-China, kunye nebango lomenzi we-100% yesivumelwano esihle.Ngaphandle kweengxelo zeziphumo ezingaguqukiyo, iisampulu enye yayingeyonyani emva kokuphinda ivavanye okufanayo, kodwa yayilungile kwi-Abbott SARS-CoV-2 kunye novavanyo lweSansure Biotech nCoV-2019.Oku kuthetha ukuba kunokubakho ukuguquguquka kweziphumo kwiindidi ezahlukeneyo zovavanyo. Nangona kunjalo, kuphononongo olwenziwa e-China15, isiphumo sovavanyo lwe-Daan Gene sahluke kakhulu (p <0.05) xa kuthelekiswa ne-reference assay echazwe kwilebhu. Nangona kunjalo, kuphononongo olwenziwa e-China15, isiphumo sovavanyo lwe-Daan Gene sahluke kakhulu (p <0.05) xa kuthelekiswa ne-reference assay echazwe kwilebhu. Тем не менее, в исследовании, проведенном в Китае15, результат анализа Daan Gene значительно отличался (p <0,05) от их лаборалинский. Nangona kunjalo, kuphononongo olwenziwa eChina15, isiphumo sokuhlalutya kukaDaan Gene sahluke kakhulu (p <0.05) kuhlalutyo lwabo lwereferensi yebhubhoratri.然而，在中国进行的研究中15，大安基因检测的结果与其实验室定义的参考检测相毂有显着 .然而，在中国进行的研究中15，大安基因检测的结果与其实验室定义的参考检测相比有显着0. Однако в исследовании, проведенном в Китае15, результаты генетического теста Daan значительно отличались (p <0,05) по сравнеланибенные с ее. Nangona kunjalo, kuphononongo olwenziwa eChina15, iziphumo zovavanyo lwemfuza yeDaan zahluke kakhulu (p <0.05) xa kuthelekiswa novavanyo lwayo lwebhubhoratri.Lo mahluko usenokuba ngenxa yobuntununtunu bovavanyo lwereferensi yokufumanisa i-SARS-CoV-2, kwaye ezinye izifundo zinokubalulekile ukumisela unobangela.
Ukongeza, uphononongo lwethu luvavanye ukusebenza ngokuthelekisayo kovavanyo lwe-SARS-CoV-2 BGI kunye ne-CRS, ebonisa isivumelwano sepesenti esincomekayo (PPA = 97.9%), isivumelwano sepesenti engalunganga (NPA = 100%), kunye nesivumelwano sepesenti iyonke ngokwesini ( OPA).).= 98.8%).Amaxabiso eKappa kaCohen abonise isivumelwano esihle (K = 0.975).Izifundo eNetherlands16 kunye neChina15 zibonise iziphumo ezihambelanayo.Uvavanyo lwe-SARS-CoV-2 BGI luhlobo olunye lofuzo (ORF1a/b) lovavanyo lokufumanisa kusetyenziswa i-10 µl yokukhulisa/ukubona eluate.Ngaphandle kwesivumelwano esihle samanani kunye neziphumo zethu zereferensi, uhlalutyo luphose iisampuli ezimbini ezilungileyo (1.22%) zesampulu iyonke.Oku kunokuba neempembelelo ezinkulu zeklinikhi kuguquko losulelo kuzo zombini izigulane kunye namanqanaba oluntu.
Olunye uhlalutyo lokuthelekisa olubandakanyiweyo kolu phononongo yayiyi-Sansure Biotech nCoV-2019 rRT-PCR (RUO) assay;ipesenti yomdlalo iyonke ibe ngama-96.3%.Amandla esivumelwano nawo anqunywe yixabiso likaCohen's Kappa, elaliyi-0.925, ebonisa isivumelwano esipheleleyo kunye ne-CRS.Kwakhona, iziphumo zethu ziyafana nezifundo eziqhutywe kwiYunivesithi yaseCentral South e-Changsha, e-China, nakwiSebe leLebhu yeKliniki yeSibhedlele saBantu saseLiuzhou, kwisiXeko saseLiuzhou, eChina17. Nangona i-concordance yezibalo ezilungileyo ezingentla zirekhodwe, uvavanyo lwe-chi-square (uvavanyo lwe-MacNemar) lubonise ukuba umphumo we-Sansure Biotech assay ube nomehluko omkhulu wezibalo xa kuthelekiswa ne-CRS (p <0.005). Nangona i-concordance yezibalo ezilungileyo ezingentla zirekhodwe, uvavanyo lwe-chi-square (uvavanyo lwe-MacNemar) lubonise ukuba umphumo we-Sansure Biotech assay ube nomehluko omkhulu wezibalo xa kuthelekiswa ne-CRS (p <0.005). Несмотря на то, что было зафиксировано указанное выше хорошее статистическое соответствие, критерий хи-квадрат (критерий Макнемара) показал, что результат анализа Sansure Biotech имеет статистически значимое различие по сравнению с CRS (p < 0,005). Nangona isivumelwano esihle samanani apha ngasentla sabhalwa, uvavanyo lwe-chi-square (uvavanyo lwe-McNemar) lubonise ukuba umphumo we-Sansure Biotech assay unomahluko ophawulekayo xa kuthelekiswa ne-CRS (p <0.005).尽管计录了上述良好的统计一致性，但卡方检验（MacNemar 检验）表明，Sansure Biotech 检测的结林0 .尽管 记录 记录 上述 上述 良好 统计 一致 性, 但但 检验 ((Mac 检验 检验 检验 检验 ,,,,,,,,,,,,,,,,,.005 .................... ...）) Несмотря на отмеченное выше хорошее статистическое соответствие, критерий хи-квадрат (критерий Макнемара) показал статистическое соответствие, критерий хи-квадрат (критерий Макнемара) показал статистическое соответствие Nangona isivumelwano esihle sezibalo esichazwe ngasentla, uvavanyo lwe-chi-square (uvavanyo lwe-McNemar) lubonise ulwahlulo olubalulekileyo (p <0.005) phakathi kwe-Sansure Biotech assay kunye ne-CRS.Iisampulu ezithandathu (3.66%) zifunyaniswe zingeyonyani xa kuthelekiswa neCRS (iThebhile eyoNgezelelweyo 1);oku kubaluleke kakhulu, ingakumbi xa kujongwa amandla osasazo lwentsholongwane.Le datha ingentla ikwaxhasa eli zinga liphantsi lobhaqo15.
Kolu phononongo, amaxabiso e-Ct amiselwa kuvavanyo ngalunye kunye neqonga elithile, ngexabiso eliphantsi le-Ct elixelwe kuvavanyo lwe-Abbott SARS-CoV-2.Esi siphumo sinokunxulumana nenkqubo ka-Abbott edityanisiweyo yovavanyo lwemfuzo yokufunyanwa kwe-SARS-CoV-2.Ngoko ke, ngokoMfanekiso 1, i-87.6% yeziphumo ze-Abbott SARS-CoV-2 zinexabiso le-Ct ngaphantsi kwe-20. Kuphela linani elincinci leziphumo zesampulu (12.4%) zazikuluhlu lwe-20-30.Amaxabiso e-CT angaphezu kwama-30 awabhalwanga.Ukongeza kusetyenziso luka-Abbott lwe-SARS-CoV-2 ifomathi yovavanyo lwemfuza yephaneli, esi siphumo sinokunxulumana nomda osezantsi wokubhaqwa (iikopi ezingama-32.5 RNA/mL) 18, ongaphantsi ngokuphindwe kathathu kunomda ophantsi wenkampani weekopi ezili-100 zeRNA. /mL.ml)19.
Olu phononongo lunemida ethile: okokuqala, asinazo iindlela ezisemgangathweni/ezibhekiselele [ezifana nomthamo wentsholongwane egazini okanye ezinye iimvavanyo zaselabhoratri (LDA)] ngenxa yokunqongophala kwemithombo.Okwesibini, yonke imizekelo esetyenzisiweyo kolu cwaningo yayiyi-swabs ye-nasopharyngeal, ngelixa iziphumo zazingasebenzi kwezinye iindidi ze-specimen, kwaye okwesithathu, ubukhulu bethu besampula buncinci.
Olu phononongo luthelekisa ukusebenza kweemvavanyo ezine ze-rRT-PCR ye-SARS-CoV-2 kusetyenziswa iisampulu ze-nasopharyngeal.Zonke iimvavanyo zokubona ziphantse zasebenza ngokufanayo, ngaphandle kovavanyo lweSansure Biotech. Ngaphandle koko, izinga eliphantsi lepositivity ichongiwe kwi-assay ye-Sansure Biotech xa kuthelekiswa ne-CRS (p <0.05). Ngaphandle koko, izinga eliphantsi lepositivity ichongiwe kwi-assay ye-Sansure Biotech xa kuthelekiswa ne-CRS (p <0.05). Кроме того, в тесте Sansure Biotech был выявлен низкий процент положительных результатов по сравнению с CRS (p <0,05). Ukongeza, uvavanyo lwe-Sansure Biotech lubonise ipesenti ephantsi yeziphumo ezilungileyo xa kuthelekiswa ne-CRS (p <0.05).此外，与CRS 相比，Sansure Biotech 检测的阳性率较低(p <0.05).此外，与CRS 相比，Sansure Biotech 检测的阳性率较低(p <0.05). Кроме того, анализ Sansure Biotech имел более низкий уровень положительных результатов по сравнению с CRS (p <0,05). Ukongeza, i-assay ye-Sansure Biotech inezinga eliphantsi le-positivity xa kuthelekiswa ne-CRS (p <0.05).Uhlalutyo lwe-Sansure Biotech nCoV-2019 (RUO) lwePPA, i-NPA kunye nesivumelwano sonke sigqithise i-93.5% ngamandla e-Cohen Kappa exabiso lesivumelwano se-0.925.Ekugqibeleni, i-Sansure Biotech Assay (RUO) idinga ukuqinisekiswa okungaphezulu kokusetyenziswa e-Ethiopia, kwaye uphando olongezelelweyo kufuneka luthathelwe ingqalelo ukuvavanya amabango avela kubakhiqizi ngabanye.
Uyilo lophononongo oluthelekisayo lwenziwe kumaziko ezempilo amane e-Addis Ababa, iSibhedlele sase-Eka Kotebe, iZiko loNyango lweCawa yeMillennium, iSibhedlele seSikhumbuzo saseZewooditu, kunye neSibhedlele seNgcali yeSifo sePhepha eSt.Idatha yaqokelelwa phakathi kwe-1 kunye ne-31 kaDisemba, i-2020. Amaziko ezonyango kolu phononongo akhethwe ngenjongo ngokusekelwe kwinani eliphezulu lamatyala kunye nokufumaneka kwamaziko amakhulu onyango kwisixeko.Ngokufanayo, izixhobo, kubandakanywa i-ABI 7500 kunye ne-Abbott m2000 izixhobo ze-PCR zexesha langempela, zikhethwe ngokweengcebiso zabenzi be-reagent ye-NAAT, kunye nezixhobo ezine ze-PCR zokufumanisa ezikhethiweyo kolu phononongo, njengoko ezininzi iilabhoratri zase-Ethiopia zisetyenziselwa ubuncinci. ezine kuzo.Uvavanyo lweGene, uvavanyo lwe-Abbott SARS-CoV-2, uvavanyo lwe-Sansure Biotech, kunye novavanyo lwe-SARS-CoV-2 BGI olwenziwe ngexesha lophononongo).
Uvavanyo lwe-SARS-CoV-2 lwenziwa ukusuka ngomhla woku-1 ukuya kowama-30 kuDisemba ka-2020 kusetyenziswa i-3 ml ye-Viral Transport Medium (VTM) (Miraclean Technology, Shenzhen, China) kubantu abaphantsi kophando lwe-COVID-19 ekubhekiselelwe kwi-EPHI.Iisampulu ze-Nasopharyngeal zaqokelelwa ngabaqokeleli besampula abaqeqeshiweyo kwaye bathunyelwa kwi-EPHI kwiipakethi ezintathu.Ngaphambi kokuhlukaniswa kwe-nucleic acid, isampuli nganye inikwe inombolo yesazisi esisodwa.Utsalo lwenziwa kwisampulu nganye ngoko nangoko ekufikeni kusetyenziswa iindlela manual kunye nokuzenzela.Ngaloo ndlela, ukukhutshwa ngokuzenzekelayo kwe-Abbott m2000, i-1.3 ml (kubandakanya i-0.8 ml ivolumu efileyo kunye ne-0.5 ml ye-extraction inlet volume) yesampuli ikhutshwe kwisampuli nganye kwaye idluliselwe kwi-Abbott DNA yeSample Preparation System (Abbott Molecular Inc. des Plaines, IL, USA).) Ibhetshi ye-96 [iisampulu ezingama-92, izilawuli zokubona ezimbini kunye nezimbini ezingezizo iitemplate zolawulo (NTC)] zifakwe kwinkqubo iyonke (ukufumana nokubhaqwa) kwemijikelo emibini ye-SARS-CoV-2 (EUA) ngexesha langempela.imigodi.Ngokufanayo, ukukhutshwa ngesandla, sebenzisa iisampulu ezifanayo (ukukhutshwa ngokuzenzekelayo kunye nokufumanisa).Ngaloo ndlela, kuyo yonke inkqubo, iisampuli ze-140 µl zaye zacatshulwa kwaye zakhutshwa kusetyenziswa i-QIAamp Viral RNA Mini Kit (QIAGEN GmbH, Hilden, eJamani) kwiibhetshi ze-24 (kubandakanywa neesampuli ze-20, ii-assay controls ezimbini kunye nee-NTC ezimbini) ngaphezulu kwemijikelo elithoba.Ii-eluates ezikhutshwe ngesandla ziye zandiswa kwaye zafunyanwa kusetyenziswa i-ABI 7500 yebhayisekile eshushu kusetyenziswa i-SARS-CoV-2 BGI assay, i-Daan Gene assay, kunye ne-Sansure Biotech assay.
Ukwahlukaniswa ngokuzenzekelayo kunye nokucocwa kwe-SARS-CoV-2 yentsholongwane ye-RNA ilandela umgaqo we-magnetic bead usebenzisa i-Abbott DNA yokulungiselela iisampulu.Ukungasebenzi kweisampulu kunye ne-solubilization yeentsholongwane zentsholongwane kuqhutyelwa ngokusebenzisa i-detergent equkethe i-guanidine isothiocyanate ukuze i-denature iprotheni kwaye ingasebenzi i-RNase.I-RNA ke ihlukaniswe kwiprotheni ngokuhlukana kwesigaba esiqinileyo usebenzisa i-silica, oko kukuthi ityuwa ye-guanidinium kunye ne-alkaline pH ye-lysis buffer ikhuthaza ukubopha i-nucleic acids kwi-silica (SiO2).Isinyathelo sokuhlanjululwa sisusa iiprotheni ezisele kunye ne-debris ukuvelisa isisombululo esicacileyo.I-RNA engafihliyo yodwa kwi-silica-based microparticles isebenzisa i-magnetic field yesixhobo20,21.Ngakolunye uhlangothi, ukuhlukaniswa kwe-manual kunye nokuhlanjululwa kwe-RNA kuqhutyelwa yindlela yekholamu ye-spin usebenzisa i-centrifugation endaweni yokuma magnetic kunye nokwahlulwa kwe-microparticles ukusuka kwi-eluent.
UVavanyo lokuFunyaniswa kwe-Abbott ngexesha lokwenyani le-SARS-CoV-2 (Abbott Molecular, Inc.) lwenziwa ngokwemiyalelo yomenzi, olufumene i-EUA19,22 kwi-WHO kunye ne-FDA.Kule protocol, ukungasebenzi kwesampuli ngaphambi kokuba ukukhutshwa kwenziwa kwindawo yokuhlambela amanzi kwi-56 ° C kwi-30 min.Emva kokungasebenzi kwentsholongwane, i-nucleic acid extraction yenziwa kwisixhobo se-Abbott m2000 SP ukusuka kwi-0.5 ml VTM usebenzisa i-Abbott m2000 DNA inkqubo yokulungiselela isampula.ngokomenzi.Ukwandiswa kunye nokufumanisa kwenziwa ngokusebenzisa isixhobo se-Abbott m2000 RT-PCR, kwaye ukufumanisa kabini kwenziwa kwi-RdRp kunye ne-N gene.I-ROX) kunye ne-VIC P (idayi ye-proprietary) ekujoliswe kuyo kunye nokufumanisa ulawulo lwangaphakathi, ukuvumela ukufumanisa ngaxeshanye zombini iimveliso zokukhulisa i-19.
Indlela yokufumanisa ukukhulisa le khithi isekelwe kwitekhnoloji ye-RT-PCR yenyathelo elinye.I-ORF1a/b kunye nofuzo lwe-N zikhethwe njengemimandla egciniweyo yi-Daan Gene Technology ukukhangela ulwandiso lwengingqi ekujoliswe kuyo.Iiprimers ezithile kunye neprobes zefluorescent (i-N gene probes ebhalwe nge-FAM, ORF1a/b probes ezibhalwe nge-VIC) ziyilelwe ukuqaphela i-SARS-CoV-2 RNA kwiisampulu.I-eluent yokugqibela kunye ne-master mixes yalungiswa ngokudibanisa i-5 µl ye-eluent ukuya kwi-20 µl ye-master mix kumthamo wokugqibela we-25 µl.Ukwandiswa kunye nokufumanisa kwenziwa ngaxeshanye kwisixhobo sePCR se-ABI 750024 sangempela.
Iijini ze-ORF1a/b kunye ne-N zichongiwe kusetyenziswa i-Sansure Biotech nCoV-2019 Nucleic Acid Diagnostic Kit (ukufumanisa i-PCR yefluorescent).Lungiselela ii-probes ezithile kwijene nganye ekujoliswe kuyo ngokukhetha itshaneli ye-FAM yengingqi ye-ORF1a/b kunye ne-ROX channel ye-N gene.Kule khithi yovavanyo, ii-eluent kunye ne-master mix reagents zongezwa ngolu hlobo lulandelayo: lungiselela i-30 µl master mix reagent kunye ne-20 µl eluted isampuli ukubhaqwa/ukukhulisa.Ixesha langempela le-PCR ABI 750025 lisetyenziselwe ukukhulisa / ukubhaqwa.
Uvavanyo lwe-SARS-CoV-2 BGI yikiti ye-fluorescent yexesha lokwenyani ye-rRT-PCR yokufunyaniswa kwe-COVID-19.Ummandla ekujoliswe kuwo ukummandla we-ORF1a/b we-SARS-CoV-2 genome, eyindlela enye yokufumanisa imfuza.Ukongeza, ijini yogcino lwendlu yomntu i-β-actin luhlobo lofuzo olulawulwa ngaphakathi.I-master mix ilungiswa ngokuxuba i-20 µl ye-master mix reagent kunye ne-10 µl yesampuli ye-RNA ekhutshiweyo kwi-plate yequla26.Isixhobo se-PCR se-ABI 7500 sefluorescent sobungakanani bexesha lokwenyani sisetyenziselwe ukukhulisa nokubhaqwa.Zonke i-nucleic acid amplification, i-PCR iqhuba iimeko zovavanyo ngalunye, kunye nokutolikwa kweziphumo zenziwa ngokwemiyalelo yomenzi ochaphazelekayo (Itheyibhile 3).
Kolu hlalutyo lokuthelekisa, asizange sisebenzise indlela yomgangatho wereferensi ukumisela imvumelwano yepesenti (elungileyo, engalunganga, kunye neyonke) kunye nezinye iiparitha zokuthelekisa uhlalutyo olune.Ukuthelekiswa kovavanyo ngalunye lwenziwa kunye ne-CRS, kolu phononongo i-CRS yamiselwa ngumgaqo othi "nayiphi na into entle" kwaye isiphumo sagqitywa, kungekhona ngovavanyo olunye, sasebenzisa ubuncinane iziphumo zovavanyo ezimbini ezihambelanayo.Ukongeza, kwimeko yosulelo lwe-COVID-19, iziphumo ezingezizo ezingezizo ziyingozi ngakumbi kuneziphumo ezingezizo zobuxoki.Ke ngoko, ukutsho ukuthi “positive” ngokuchanekileyo kangangoko kunokwenzeka kwisiphumo seCRS, ubuncinane iimvavanyo ezimbini zovavanyo kufuneka zibe positive, okuthetha ukuba ubuncinane isiphumo esiqinisekileyo sinokuvela kuvavanyo lwe-EUA.Ke ngoko, kwiziphumo zovavanyo ezine, iziphumo zovavanyo ezimbini okanye ngaphezulu ezinika iziphumo ezifanayo zithathwa njengeyinyani eqinisekileyo okanye i-negative18,27.
Idatha iqokelelwe kusetyenziswa iifom zokutsalwa kwedatha ezicwangcisiweyo, ukufakwa kwedatha kunye nohlalutyo lwenziwa kusetyenziswa i-Excel statistical software kunye ne-SPSS version 23.0 yeenkcukacha-manani ezichazayo.Imvumelwano encomekayo, engalunganga, kunye neyonke yeepesenti yahlalutywa, kwaye inqaku leKappa lasetyenziswa ukumisela iqondo lesivumelwano sendlela nganye neCRS.Amaxabiso eKappa atolikwa ngolu hlobo lulandelayo: 0.01 ukuya ku-0.20 kwisivumelwano esincinci, 0.21 ukuya ku-0.40 kwisivumelwano ngokubanzi, 0.41-0.60 kwisivumelwano esiphakathi, 0.61-0.80 kwisivumelwano esikhulu kunye ne-0.81-0.99 yesivumelwano esipheleleyo28.
Ukuvunywa kwemigaqo yokuziphatha kwafunyanwa kwiYunivesithi yaseAddis Ababa kwaye zonke iiprothokholi zovavanyo zolu phononongo zavunywa yiBhodi yezeNzululwazi yezeNzululwazi yezeNzululwazi ye-Ethiopian Public Health Institute.Inombolo yereferensi yeLayisensi yeeNqobo zokuziphatha ze-EPHI yi-EPHI/IRB-279-2020.Zonke iindlela zasetyenziswa ngokuhambelana neengcebiso kunye nezibonelelo ze-Ethiopian National Comprehensive Guidelines for the Treatment of COVID-19.Ukongezelela, imvume ebhaliweyo ebhaliweyo ifunyenwe kubo bonke abathathi-nxaxheba bokufunda ngaphambi kokuthatha inxaxheba kwisifundo.
Yonke idatha efunyenweyo okanye ehlalutyiweyo kolu phononongo ifakiwe kweli nqaku lipapashiweyo.Idatha exhasa iziphumo zolu phononongo iyafumaneka kumbhali ochaphazelekayo ngesicelo esinengqiqo.
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