Ukusebenza kwezivivinyo ezine ze-nucleic acid amplification ukuhlonza i-SARS-CoV-2 e-Ethiopia

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Selokhu kwagqashuka isifo se-coronavirus (COVID-19) sika-2019, izivivinyo eziningi ze-nucleic acid amplification zezentengiselwano (NAATs) zenziwe emhlabeni wonke futhi seziphenduke izivivinyo ezijwayelekile. Nakuba ukuhlolwa okuningana kwathuthukiswa ngokushesha futhi kwasetshenziswa ekuhlolweni kokuxilonga elabhorethri, ukusebenza kwalezi zivivinyo akuzange kuhlolwe ngezilungiselelo ezihlukahlukene. Ngakho-ke, lolu cwaningo luhlose ukuhlola ukusebenza kwe-Abbott SARS-CoV-2, Daan Gene, BGI, kanye ne-Sansure Biotech assays kusetshenziswa i-Composite Reference Standard (CRS). Ucwaningo lwenziwe e-Ethiopian Public Health Institute (EPHI) kusukela ngomhla ka-1 kuya ku-30 ​​Disemba 2020. Amasampula e-nasopharyngeal angu-164 akhishwe kusetshenziswa ikhithi encane ye-QIAamp RNA kanye nesistimu yokulungiselela isampula ye-Abbott DNA. Kuma-specimens angu-164, ama-59.1% ayenayo kanti ama-40.9% ayengenayo i-CRS. I-Sansure Biotech positivity ibiphansi kakhulu uma iqhathaniswa ne-CRS (p <0.05). I-Sansure Biotech positivity ibiphansi kakhulu uma iqhathaniswa ne-CRS (p <0.05). Положительные результаты I-Sansure Biotech были значительно ниже по сравнению с CRS (p <0,05). Imiphumela emihle ye-Sansure Biotech ibiphansi kakhulu uma iqhathaniswa ne-CRS (p <0.05).与CRS 相比，Sansure Biotech 的阳性率显着较低（p <0.05）.与CRS 相比，Sansure Biotech 的阳性率显着较低（p <0.05）. I-Sansure Biotech было значительно меньше положительных результатов по сравнению с CRS (p <0,05). I-Sansure Biotech ibe nemiphumela emihle embalwa kakhulu uma iqhathaniswa ne-CRS (p <0.05).Isivumelwano esiphelele sokuhlaziya okune besingu-96.3–100% uma siqhathaniswa ne-CRS. Ngaphezu kwesilinganiso esiphansi se-positivity sokuhlolwa kwe-Sansure Biotech, ukusebenza kwezivivinyo ezine kucishe kwaqhathaniseka. Kanjalo, ukuhlola kwe-Sansure Biotech [Ucwaningo Kuphela (RUO)] kudinga ukuqinisekiswa okwengeziwe ukuze kusetshenziswe e-Ethiopia. Okokugcina, ucwaningo olwengeziwe kufanele lucatshangelwe ukuze kuhlolwe izivivinyo ezinezicelo ezifanele zomkhiqizi.
Ukuhlolwa kwaselabhorethri kuyingxenye ye-World Health Organization (WHO) Strategic Plan ye-Coronavirus Disease 2019 (COVID-19) Preparedness and Response (SPRP). I-WHO yeluleka ngokuthi amazwe adinga ukwakha amandla aselabhorethri ukuze athuthukise ukulungela, ukuphathwa kwecala ngendlela efanele, ukuqapha kanye nokusabela ngokushesha ezinseleleni zempilo yomphakathi. Lokhu kusikisela ukuthi indima yaselabhorethri ibalulekile ekuvezeni isifo kanye ne-epidemiology yama-agent athathelwanayo avelayo kanye nokulawula ukusabalala kwawo.
Ukuxilongwa kwe-COVID-19 kudinga ulwazi lwezifo kanye nezokwelapha, izimpawu/izimpawu zomuntu siqu, kanye nedatha ye-radiographic neyaselabhorethri2. Selokhu kwabikwa ukugqashuka kwe-COVID-19 e-Wuhan, e-China, izivivinyo eziningi ze-nucleic acid amplification (NAATs) zezentengiselwano zenziwe emhlabeni jikelele. I-Reverse transcript ye-polymerase chain reaction yesikhathi sangempela (rRT-PCR) isetshenziswe njengendlela evamile kanye nendlela evamile yokuxilongwa kwaselabhorethri kwe-acute acute kupumua syndrome 2 (SARS-CoV-2)3 ukutheleleka. Ukutholwa kwamangqamuzana e-SARS-CoV-2 ngokuvamile kusekelwe kuzakhi zofuzo ze-N (nucleocapsid protein), E (invelope protein gene), kanye ne-RdRp (i-RNA-dependent RNA polymerase gene) ku-ORF1a/b (uhlaka lokufunda oluvulekile 1a/b) . gene) indawo ekhonjwe ku-genome yegciwane. Zibhekwa njengezifunda ezilondoloziwe eziyinhloko ezitholakala kuma-virus genomes ukuqashelwa kwegciwane4. Phakathi kwalezi zakhi zofuzo, izakhi zofuzo ze-RdRp kanye no-E zinokuzwela okuphezulu kokutholwa kokuhlaziya, kuyilapho isakhi sofuzo se-N sinokuzwela okuphansi kokuhlaziya5.
Ukusebenza kokuhlolwa kwe-PCR kungase kwehluke kuye ngezinto ezihlukahlukene ezifana nalezi: izinto ezivuselelayo, ama-amplification/reagents okuthola, indlela yokukhipha, ikhwalithi yomshini we-PCR nezinye izisetshenziswa. Kusukela ngo-Ephreli 2020, amathuluzi okuxilonga angaphezu kwama-48 ahlukene avela emazweni ayisishiyagalolunye athole Ukugunyazwa Kokusetshenziswa Kwezimo Eziphuthumayo (i-EUA) ukuze kuhlolwe i-COVID-196. E-Ethiopia, kusetshenziselwa izinkundla ze-PCR zesikhathi sangempela ezingaphezu kwe-14 ukuze kutholwe i-PCR ye-SARS-CoV-2 ezikhungweni zezempilo zomphakathi ezingama-26, okuhlanganisa i-ABI 7500, Abbott m2000, Roche 48000 ne-Quant-studio7. Ngaphezu kwalokho, kuyatholakala amakhithi okuhlola e-PCR ahlukahlukene, njengokuhlolwa kwe-Daan Gene, ukuhlolwa kwe-Abbott SARS-CoV-2, ukuhlolwa kwe-Sansure Biotech, kanye nokuhlolwa kwe-SARS-CoV-2 BGI. Yize i-rRT-PCR izwela kakhulu, ezinye iziguli ezine-COVID-19 zibika imiphumela engemihle engamanga ngenxa yamakhophi anganele e-viral ribonucleic acid (RNA) kumasampula ngenxa yokuqoqwa okungafanele, ukuthutha, ukugcinwa nokuphathwa, nokuhlolwa kwaselabhorethri. izimo nezenzo zabasebenzi8. Ngaphezu kwalokho, isampula noma lawula ukuphathwa kabi, ukulungiselelwa komkhawulo womjikelezo (Ct), kanye nokuhlangana kabusha namanye ama-nucleic acid e-pathogenic noma i-SARS-CoV-2 RNA engasebenzi/esele kungaholela emiphumeleni emihle engamanga ekuhlolweni kwe-rRT-PCR9. Ngakho-ke, kusobala ukuthi ukuhlolwa kwe-PCR kungakwazi ukubona abathwali bezingcezu zofuzo, njengoba bengakwazi ngisho nokuhlukanisa phakathi kwezakhi zofuzo zegciwane ezisebenza ngempela, ngakho-ke ukuhlola kungakwazi ukukhomba abathwali kuphela hhayi iziguli10. Ngakho-ke, kubalulekile ukuhlola ukusebenza kokuxilonga usebenzisa izindlela ezijwayelekile esimisweni sethu. Nakuba ama-reagents amaningi e-NAAT etholakala e-Ethiopian Public Health Institute (EPHI) kanye nezwe lonke, akukho ukuhlolwa okuqhathaniswayo kokusebenza kwazo okubikiwe. Ngakho-ke, lolu cwaningo lwaluhlose ukuhlola ukusebenza okuqhathaniswayo kwezinsiza ezitholakalayo zentengiso ukuze kutholwe i-SARS-CoV-2 nge-rRT-PCR kusetshenziswa izibonelo zomtholampilo.
Isamba sabahlanganyeli abangu-164 abanezinsolo ze-COVID-19 bafakiwe kulolu cwaningo. Iningi lamasampula lalivela ezikhungweni zokwelapha (118/164 = 72%), kuyilapho abahlanganyeli abangama-46 (28%) abasele bebevela ezikhungweni ezingalashwa. Phakathi kwabahlanganyeli abangazange belashwe kulesi sikhungo, abangu-15 (9.1%) babenamacala okusolakala ukuthi atholakala emtholampilo kanti abangu-31 (18.9%) baba nokuxhumana namacala aqinisekisiwe. Abahlanganyeli abangamashumi ayisishiyagalolunye nantathu (56.7%) kwakungamadoda, kanti iminyaka yobudala (± SD) yabahlanganyeli yayiyiminyaka engu-31.10 (± 11.82).
Kulolu cwaningo, kunqunywe amanani amahle kanye namabi okuhlolwa okune kwe-COVID-19. Ngakho-ke, amanani amahle okuhlolwa kwe-Abbott SARS-CoV-2, i-Daan Gene 2019-nCoV assay, i-SARS-CoV-2 BGI assay, kanye ne-Sansure Biotech 2019-nCoV assay ibingu-59.1%, 58.5%, 57.9% kanye no-55.5% ngokulandelanayo. . Izinga lereferensi eliyinhlanganisela elihle nelibi (CRS) lalingama-97 (59.1%) kanye nama-67 (40.9%), ngokulandelana (Ithebula 1). Kulolu cwaningo, incazelo ye-CRS yayisekelwe emthethweni “noma yimuphi omuhle”, lapho emiphumeleni emine yokuhlola, imiphumela yokuhlolwa emibili noma ngaphezulu enikeze umphumela ofanayo ibhekwa njengephozithivu yangempela noma inegethivu.
Kulolu cwaningo, sithole isivumelwano sephesenti elingalungile (NPA) lika-100% (95% CI 94.6–100) kukho konke ukuhlaziya uma kuqhathaniswa ne-CRS. Ukuhlaziywa kweSansure Biotechnology kubonise i-PPA encane engama-93.8% (95% CI 87.2-97.1) kanye nokuhlaziywa kwe-Daan Gene 2019-nCoV kube nesivumelwano esiphelele sama-99.4% (95% CI 96.6-99.9). Ngokuphambene, isivumelwano sisonke phakathi kokuhlolwa kwe-SARS-CoV-2 BGI kanye nokuhlolwa kwe-Sansure Biotech 2019-nCoV bekungama-98.8% nama-96.3% ngokulandelana (Ithebula 2).
I-Cohen's kappa coefficient yesivumelwano phakathi kwemiphumela yokuhlola ye-CRS ne-Abbott SARS-CoV-2 yayingaguquguquki ngokugcwele (K = 1.00). Ngokufanayo, amanani we-kappa ka-Cohen atholwe ngu-Daan Gene 2019-nCoV, SARS-CoV-2 BGI, kanye ne-Sansure Biotech 2019-nCoV nawo ahambisana ngokugcwele ne-CRS (K ≥ 0.925). Kulokhu kuhlaziya okuqhathanisayo, ukuhlolwa kwe-chi-square (ukuhlolwa kwe-McNemar) kubonise ukuthi imiphumela yokuhlola ye-Sansure Biotech 2019-nCoV yayihluke kakhulu emiphumeleni ye-CRS (p = 0.031) (Ithebula 2).
Njengoba kuboniswe ku-Fig.1 iphesenti yenani eliphansi le-Ct (< 20 Ct) le-Abbott SARS-CoV-2 assay (ihlanganiswe i-RdRp ne-N gene) lalingu-87.6% kanye nevelu ye-Ct ye-ORF1a/b ye-Sansure Biotech 2019-nCoV ibonise ukuthi iphesenti eliphansi Inani le-Ct (< 20 Ct) lalingu-50.3% kanye nevelu ye-Ct ephezulu (36–40 Ct) ibingu-3.2%. 1 iphesenti yenani eliphansi le-Ct (< 20 Ct) le-Abbott SARS-CoV-2 assay (ihlanganiswe i-RdRp ne-N gene) lalingu-87.6% kanye nevelu ye-Ct ye-ORF1a/b ye-Sansure Biotech 2019-nCoV ibonise ukuthi iphesenti eliphansi Inani le-Ct (< 20 Ct) lalingu-50.3% kanye nevelu ye-Ct ephezulu (36–40 Ct) ibingu-3.2%.Njengoba kuboniswe ku-Fig.1, процент наименьшего значения Ct (< 20 Ct) анализа Abbott SARS-CoV-2 (комбинированный ген RdRp and N) составил 87,6%, а значеение на ORF 1 ORF 2019-nCoV показало что процент низкого значения Ct (< 20 Ct) составлял 50,3%, а высокое значение Ct (36–40 Ct) составляло 3,2%. 1, iphesenti yenani eliphansi le-Ct (< 20 Ct) ukuhlaziya kwe-Abbott SARS-CoV-2 (uhlobo oluhlanganisiwe lwe-RdRp no-N) lalingu-87.6%, futhi inani le-Ct le-ORF1a/b ukuhlaziywa kofuzo lwe-Sansure Biotech 2019-nCoV libonisiwe. ukuthi iphesenti yenani eliphansi le-Ct (< 20 Ct) libalelwa ku-50.3%, kanye nenani eliphakeme Ct (36–40 Ct) ibalwa ku-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）为19-Biotech87.6Co2%检测的ORF1a/b 基因Ct 值显示低Ct 值(< 20 Ct) 的百分比為50.3%，高Ct 值(36–40 Ct) 的百分比为3. Njengoba kuboniswe kuMfanekiso 1, iphesenti yenani le-Ct eliphansi kakhulu (< 20 Ct) lokuhlolwa kwe-Abbott SARS-CoV-2 (inhlanganisela ye-RdRp ne-N gene) lingu-87.6%, inani le-ORF1a/b le-Ct yohlobo lokuhlola lwe-Sansure Biotech 2019-nCoV ikhombisa i-Ct 值 ephansi(< 20 Ct) amaphesenti angu-50.3%,高Ct 值(36–40 Ct) 的 amaphesenti angu-3.2%. Как показано ku-рисунке 1, анализ Abbott SARS-CoV-2 (сочетающий гены RdRp и N) имел самое низкое процентное значение Ct (< 20 Ct% , 8, 8, 8 гена ORF1a/b в исследовании I-Sansure Biotech 2019- Анализ nCoV показал низкий Ct. Njengoba kukhonjisiwe kuMfanekiso 1, ukuhlolwa kwe-Abbott SARS-CoV-2 (okuhlanganisa ufuzo lwe-RdRp ne-N) ibe nenani eliphansi lephesenti le-Ct (< 20 Ct) ku-87.6%, kuyilapho inani le-Ct lofuzo lwe-ORF1a/b ku-Sansure. Ucwaningo lwe-Biotech 2019 - Ukuhlaziywa kwe-nCoV kubonise i-Ct ephansi. Процент значений (< 20 Ct) составил 50,3%, а процент высоких значений Ct (36–40 Ct) составил 3,2%. Iphesenti lamanani (< 20 Ct) lalingu-50.3%, futhi iphesenti lamanani aphezulu e-Ct (36–40 Ct) lalingu-3.2%.Ukuhlolwa kwe-Abbott SARS-CoV-2 B kuqoshwe amanani e-Ct angaphezu kuka-30. Ngakolunye uhlangothi, kwi-BGI SARS-CoV-2 assay gene ORF1a/b yayinenani eliphezulu le-Ct (> 36 Ct) iphesenti lalingu-4% (Fig. 1). Ngakolunye uhlangothi, kwi-BGI SARS-CoV-2 assay gene ORF1a/b yayinenani eliphezulu le-Ct (> 36 Ct) iphesenti lalingu-4% (Fig. 1). С другой стороны, в анализе BGI SARS-CoV-2 i-ORF1a/b futhi высокое значение Ct (> 36 Ct), процент которого составлял 4% (рис. 1). Ngakolunye uhlangothi, ekuhlaziyeni kofuzo lwe-BGI SARS-CoV-2 i-ORF1a/b yayinenani eliphezulu le-Ct (> 36 Ct), iphesenti layo lalingu-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）. Ngakolunye uhlangothi, ekutholweni kwe-BGI SARS-CoV-2, iphesenti lofuzo lwe-ORF1a/b elinevelu ephezulu ye-Ct (>36 Ct) ngu-4% (Umfanekiso 1). С другой стороны, в анализе BGI SARS-CoV-2 процент генов ORF1a/b с высокими значениями Ct (>36 Ct) составил 4% (рис. 1). Ngakolunye uhlangothi, ekuhlaziyeni kwe-BGI SARS-CoV-2, iphesenti lezakhi zofuzo ze-ORF1a/b ezinamavelu aphezulu e-Ct (>36 Ct) lalingu-4% (Fig. 1).
Kulolu cwaningo, sithathe amasampula e-nasopharyngeal angu-164. Kuzo zonke izinhlobo zokuhlola, ukuhlukaniswa kwe-RNA nokukhulisa kwenziwa kusetshenziswa izindlela namakhithi anconywe abakhiqizi abafanele.
Lolu cwaningo lubonise ukuthi ukuhlolwa kuka-Abbott kwe-SARS-CoV-2 kunokusebenza kokutholwa okufanayo nokwe-CRS, ngekhonkokhodensi engu-100% enhle, engemihle, kanye neyonke. Isivumelwano se-kappa sika-Cohen singu-1.00, okubonisa isivumelwano esigcwele ne-CRS. Ucwaningo olufanayo olwenziwa yiNyuvesi yaseWashington e-US luthole ukuthi ukuzwela okuphelele kanye nokucaciswa kokuhlolwa kwe-Abbott kwe-SARS-CoV-2 kwakungama-93% kanye ne-100%, ngokulandelana, uma kuqhathaniswa nokuhlolwa okunqunyelwe ilabhorethri (LDA) ye-CDC. . 11. Isistimu yokuthola i-Abbott SARS-CoV-2 isekelwe ekutholweni okuhlangene okuhlangene kwezakhi zofuzo ze-N kanye ne-RdRp, njengoba zombili izakhi zofuzo zizwela kakhulu, kunciphisa amanga angamanga12. Ucwaningo olwenziwa e-Vienna, e-Austria luphinde lwabonisa ukuthi amavolumu amakhulu esampula yokukhipha kanye nokutholwa kwamavolumu ancishisiwe kunciphisa imiphumela yokuhlanjululwa futhi kwanda ukusebenza kahle kokutholwa13. Ngakho-ke, ukufana okuphelele kuka-Abbott kokuhlolwa kwe-SARS-CoV-2 kungahlotshaniswa nesistimu yokuthola inkundla ethola ngasikhathi sinye izakhi zofuzo ezihlanganisiwe, ikhiphe inani elikhulu lamasampuli (0.5 ml), futhi isebenzise inani elikhulu le-eluent (40 µl).
Imiphumela yethu iphinde yabonisa ukuthi ukusebenza kokutholwa kokuhlolwa kofuzo kwe-Daan kwakucishe kufane nalokho kwe-CRS. Lokhu kuhambisana nocwaningo14 olwenziwa eNyuvesi yase-Anhui e-Huainan, e-China, kanye nesimangalo somkhiqizi sesivumelwano esihle esingu-100%. Naphezu kwemibiko yemiphumela engaguquki, isampula elilodwa lalingelona iqiniso ngemuva kokuhlola kabusha i-eluate efanayo, kodwa lalilungile ezivivinyweni ze-Abbott SARS-CoV-2 kanye ne-Sansure Biotech nCoV-2019. Lokhu kuphakamisa ukuthi kungase kube nokuhlukahluka emiphumeleni ezinhlotsheni ezahlukene zokuhlola. Noma kunjalo, ocwaningweni olwenziwa e-China15, umphumela wokuhlolwa kwe-Daan Gene wawuhluke kakhulu (p <0.05) uma kuqhathaniswa nokuhlolwa kwereferensi echazwe ilebhu. Noma kunjalo, ocwaningweni olwenziwa e-China15, umphumela wokuhlolwa kwe-Daan Gene wawuhluke kakhulu (p <0.05) uma kuqhathaniswa nokuhlolwa kwereferensi echazwe ilebhu. Тем не менее, в исследовании, проведенном в Китае15, результат анализа Daan Gene значительно отличался (p <0,05) от их лаборанались отличался. Nokho, ocwaningweni olwenziwa e-China15, umphumela wokuhlaziya we-Daan Gene wawuhluke kakhulu (p <0.05) ekuhlaziyweni kwereferensi yabo yaselabhorethri.15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 сравнетического теста Daan тестом. Kodwa-ke, ocwaningweni olwenziwa e-China15, imiphumela yokuhlolwa kofuzo kuka-Daan yayihluke kakhulu (p <0.05) uma kuqhathaniswa nokuhlolwa kwayo kwelebhu.Lokhu kwehluka kungase kubangelwe ukuzwela kokuhlolwa kwereferensi ukuze kutholwe i-SARS-CoV-2, futhi ezinye izifundo zingabaluleka ukuze kutholwe imbangela.
Ngaphezu kwalokho, ucwaningo lwethu luhlole ukusebenza okuqhathaniswayo kokuhlolwa kwe-SARS-CoV-2 BGI ne-CRS, okubonisa isivumelwano samaphesenti amahle kakhulu (PPA = 97.9%), isivumelwano sephesenti elingalungile (NPA = 100%), kanye nesivumelwano samaphesenti sisonke ngobulili ( OPA). ). = 98.8%). Amanani e-Cohen's Kappa abonise ukuvumelana okuhle (K = 0.975). Izifundo e-Netherlands16 nase-China15 zibonise imiphumela engaguquki. Ukuhlolwa kwe-SARS-CoV-2 BGI ukuhlola kofuzo olulodwa (ORF1a/b) kusetshenziswa i-10 µl amplification/detection eluate. Naphezu kwesivumelwano esihle sezibalo nemiphumela yethu yereferensi, ukuhlaziya kugeje amasampuli amabili amahle (1.22%) esamba sesampula. Lokhu kungaba nomthelela omkhulu emitholampilo ekushintsheni kokudlulisela kuwo womabili amazinga esiguli nawomphakathi.
Okunye ukuhlaziya okuqhathanisayo okufakwe kulolu cwaningo kwakuyisivivinyo seSansure Biotech nCoV-2019 rRT-PCR (RUO); isilinganiso somdlalo sesisonke sibe ngama-96.3%. Amandla esivumelwano aphinde anqunywa inani le-Cohen's Kappa, elingu-0.925, elibonisa isivumelwano esigcwele ne-CRS. Futhi, imiphumela yethu iyafana nezifundo ezenziwa e-Central South University e-Changsha, e-China, nase-Clinical Laboratory Department yase-Liuzhou People's Hospital, e-Liuzhou City, e-China17. Ngisho noma ikhonkodensi yezibalo enhle engenhla yarekhodwa, ukuhlolwa kwe-chi-square (ukuhlolwa kwe-MacNemar) kubonise ukuthi umphumela wokuhlolwa kwe-Sansure Biotech ube nomehluko obalulekile ngokwezibalo uma kuqhathaniswa ne-CRS (p <0.005). Ngisho noma ikhonkodensi yezibalo enhle engenhla yarekhodwa, ukuhlolwa kwe-chi-square (ukuhlolwa kwe-MacNemar) kubonise ukuthi umphumela wokuhlolwa kwe-Sansure Biotech ube nomehluko obalulekile ngokwezibalo uma kuqhathaniswa ne-CRS (p <0.005). Несмотря на то, что было зафиксировано указанное выше хорошее статистическое соответствие, критерий хи-квадрат (критерий Макнезей, критерий хи-квадрат (критерий Макнезра, той) I-Sansure Biotech имеет статистически значимое различие по сравнению с CRS (p <0,005). Nakuba isivumelwano esihle sezibalo esingenhla sarekhodwa, ukuhlolwa kwe-chi-square (ukuhlolwa kwe-McNemar) kubonise ukuthi umphumela wokuhlolwa kwe-Sansure Biotech ube nomehluko obalulekile ngokwezibalo uma kuqhathaniswa ne-CRS (p <0.005).尽管记录了上述良好的统计一致性，但卡方检验（MacNemar 检验）表明，Sansure Biotech 检测的结果会相比具有统计学显着差异（p <0.005）.尽管 记录 上述 良好 统计 一致性 , 但 检验 （(macnemar 检验 表明 ， , sansure biotech 检测具有 显着 （(p <0.005。。。。。 Несмотря на отмеченное выше хорошее статистическое соответствие, критерий хи-квадрат (критерий Макнемара) показал статистистически значи0,у IMEжду анализом Sansure Biotech kanye ne-CRS. Ngaphandle kwesivumelwano esihle sezibalo esiphawulwe ngenhla, ukuhlolwa kwe-chi-square (ukuhlolwa kwe-McNemar) kubonise umehluko obalulekile ngokwezibalo (p <0.005) phakathi kwe-Sansure Biotech assay kanye ne-CRS.Amasampula ayisithupha (3.66%) atholwe engamanga uma kuqhathaniswa ne-CRS (Ithebula Lokwengeza 1); lokhu kubaluleke kakhulu, ikakhulukazi uma kubhekwa amandla okudluliselwa kwegciwane. Idatha engenhla iphinde isekele leli zinga eliphansi lokutholwa15.
Kulolu cwaningo, amanani e-Ct anqunywa ku-assay ngayinye neplathifomu ngokulandelanayo, ngenani eliphansi kakhulu le-Ct elibikwe ekuhlolweni kwe-Abbott SARS-CoV-2. Lo mphumela ungase uhlobane nohlelo luka-Abbott oluhlanganisiwe lokuhlola izakhi zofuzo ngesikhathi esisodwa ukuze kutholwe i-SARS-CoV-2. Ngakho-ke, ngokoMdwebo 1, ama-87.6% wemiphumela ye-Abbott SARS-CoV-2 ayenamavelu e-Ct angaphansi kuka-20. Inani elincane kuphela lemiphumela yesampula (12.4%) eyayisebangeni lama-20-30. Amanani e-Ct angaphezu kuka-30 awazange arekhodwe. Ngokungeziwe ekusebenziseni kuka-Abbott ifomethi yephaneli yokuhlola izakhi zofuzo yakwa-SARS-CoV-2, lo mphumela ungase uhlotshaniswe nomkhawulo ophansi wokutholwa (amakhophi angu-32.5 RNA/mL)18, ongaphansi ngokuphindwe kathathu kunomkhawulo ophansi wenkampani wamakhophi ayi-100 e-RNA. /mL. ml) 19.
Lolu cwaningo lunemikhawulo ethile: okokuqala, asinazo izindlela ezijwayelekile/eziyisithenjwa [ezifana nomthamo wegciwane egazini noma ezinye izivivinyo zaselabhorethri (LDA)] ngenxa yokuntuleka kwezinsiza. Okwesibili, zonke izibonelo ezisetshenziswe kulolu cwaningo zaziyi-nasopharyngeal swabs, kuyilapho imiphumela yayingasebenzi kwezinye izinhlobo ze-specimen, kanti okwesithathu, usayizi wethu wesampula wawuncane.
Lolu cwaningo luqhathanise ukusebenza kwezivivinyo ezine ze-rRT-PCR ze-SARS-CoV-2 kusetshenziswa amasampula e-nasopharyngeal. Zonke izivivinyo zokuthola zinokusebenza okucishe kuqhathaniswe, ngaphandle kokuhlolwa kweSansure Biotech. Ngaphandle kwalokho, izinga eliphansi le-positivity likhonjwe ekuhlolweni kwe-Sansure Biotech uma kuqhathaniswa ne-CRS (p <0.05). Ngaphandle kwalokho, izinga eliphansi le-positivity likhonjwe ekuhlolweni kwe-Sansure Biotech uma kuqhathaniswa ne-CRS (p <0.05). Кроме того, в тесте Sansure Biotech был выявлен низкий процент положительных результатов по сравнению с CRS (p <0,05). Ngaphezu kwalokho, ukuhlolwa kwe-Sansure Biotech kubonise iphesenti eliphansi lemiphumela emihle uma kuqhathaniswa 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). Ngaphezu kwalokho, ukuhlolwa kwe-Sansure Biotech kube nenani eliphansi le-positivity uma kuqhathaniswa ne-CRS (p <0.05).Ukuhlaziywa kwe-Sansure Biotech nCoV-2019 (RUO) kwe-PPA, i-NPA kanye nesivumelwano sisonke kudlule u-93.5% ngamandla we-Cohen Kappa yenani lesivumelwano elingu-0.925. Okokugcina, iSansure Biotech Assay (RUO) idinga ukuqinisekiswa okwengeziwe ukuze isetshenziswe e-Ethiopia, futhi ucwaningo olwengeziwe kufanele lucatshangelwe ukuze kuhlolwe izimangalo ezivela kumkhiqizi ngamunye.
Umklamo wokuqhathanisa wenziwa ezikhungweni zezempilo ezine e-Addis Ababa, Eka Kotebe Hospital, Millennium Church Treatment Centre, Zewooditu Memorial Hospital, kanye neSt. Peter's Tuberculosis Specialist Hospital. Idatha yaqoqwa phakathi kuka-Disemba 1 kanye no-31, 2020. Izikhungo zezokwelapha zalolu cwaningo zikhethwe ngenhloso ngokusekelwe enanini lazo eliphezulu lezigameko kanye nokutholakala kwezikhungo zokwelashwa ezinkulu edolobheni. Ngokufanayo, amathuluzi, okuhlanganisa amathuluzi e-PCR e-ABI 7500 kanye ne-Abbott m2000 yesikhathi sangempela, akhethwa ngokuvumelana nezincomo zabakhiqizi be-reagent ye-NAAT, futhi amakhithi amane okuthola i-PCR akhethiwe kulolu cwaningo, njengoba amalabhorethri amaningi e-Ethiopia asebenzisa okungenani okungenani. ezine zazo. Ukuhlolwa kweGene, ukuhlolwa kwe-Abbott SARS-CoV-2, ukuhlolwa kwe-Sansure Biotech, kanye nokuhlolwa kwe-SARS-CoV-2 BGI okwenziwe phakathi nocwaningo).
Ukuhlolwa kwe-SARS-CoV-2 kwenziwa kusukela ngomhla lu-1 kuya zingama-30 kuZibandlela wezi-2020 kusetshenziswa u-3 ml we-Viral Transport Medium (VTM) (Miraclean Technology, Shenzhen, China) kubantu abaphenywayo nge-COVID-19 okubhekiselwe ku-EPHI. Amasampula e-Nasopharyngeal aqoqwe abaqoqi besampula abaqeqeshiwe futhi athunyelwa ku-EPHI ngamaphakethe amathathu. Ngaphambi kokuhlukaniswa kwe-nucleic acid, isampula ngalinye linikezwa inombolo kamazisi ehlukile. Ukukhipha kwenziwa kusampula ngayinye ngokushesha lapho ufika kusetshenziswa izindlela zokuzikhipha ngesandla nezizenzekelayo. Ngakho-ke, ukuze kukhishwe okuzenzakalelayo kwe-Abbott m2000, u-1.3 ml (okuhlanganisa ivolumu efile engu-0.8 ml kanye nevolumu yokukhipha i-inlet engu-0.5 ml) yesampula yakhishwa kusampula ngayinye futhi yadluliselwa ku-Abbott DNA Sample Preparation System (Abbott Molecular Inc. des Plaines, IL, USA). ) Iqoqo lama-96 [amasampuli angu-92, izilawuli zokubona ezimbili nezilawuli ezimbili ezingezona izifanekiso (NTC)] zifakiwe kunqubo iyonke (ukubuyisa nokutholwa) kwemizuliswano emibili ye-SARS-CoV-2 (EUA) ngesikhathi sangempela. izimayini. Ngokufanayo, ekukhipheni mathupha, sebenzisa amasampuli afanayo (ukukhipha okuzenzakalelayo nokutholwa). Ngakho, kuyo yonke inqubo, amasampuli angu-140 µl acashunwa futhi akhishwa kusetshenziswa i-QIAamp Viral RNA Mini Kit (QIAGEN GmbH, Hilden, Germany) ngamaqoqo angu-24 (okuhlanganisa amasampula angu-20, izilawuli ezimbili zokuhlola kanye nama-NTC amabili) emizuliswaneni eyisishiyagalolunye. Ama-eluate akhishwe mathupha akhuliswa futhi atholwa kusetshenziswa i-ABI 7500 thermal cycler kusetshenziswa i-SARS-CoV-2 BGI assay, i-Daan Gene assay, kanye ne-Sansure Biotech assay.
Ukuhlukaniswa okuzenzakalelayo nokuhlanzwa kwe-SARS-CoV-2 viral RNA kulandela isimiso sobuhlalu obuzibuthe sisebenzisa amasampula okulungisa isampula e-Abbott DNA. Ukungasebenzi kwamasampula kanye nokuhlanganiswa kwezinhlayiya zegciwane kwenziwa kusetshenziswa okokuhlanza okuqukethe i-guanidine isothiocyanate ukuze kukhishwe amaprotheni futhi kwenze i-RNase ingasebenzi. I-RNA ibe isihlukaniswa neprotheni ngokuhlukaniswa kwesigaba esiqinile kusetshenziswa i-silica, okungukuthi usawoti we-guanidinium kanye ne-alkaline pH ye-lysis buffer ikhuthaza ukubophezela kwama-nucleic acid ku-silica (SiO2). Isinyathelo sokuhlanza sisusa amaprotheni asele kanye nemfucumfucu ukukhiqiza isisombululo esicacile. I-RNA esobala ihlukanisiwe kuma-microparticles asekelwe ku-silica kusetshenziswa amandla kazibuthe wensimbi20,21. Ngakolunye uhlangothi, ukuhlukaniswa okwenziwa ngesandla kanye nokuhlanzwa kwe-RNA kwenziwa ngendlela yekholomu ye-spin kusetshenziswa i-centrifugation esikhundleni sokuma kazibuthe kanye nokuhlukaniswa kwama-microparticles kusukela ku-eluent.
I-Abbott Real-Time SARS-CoV-2 Detection Test (Abbott Molecular, Inc.) yenziwa ngokwemiyalelo yomkhiqizi, ethole i-EUA19,22 evela ku-WHO kanye ne-FDA. Kule phrothokholi, ukungasebenzi kwesampula ngaphambi kokukhipha kwenziwa kubhavu wamanzi ku-56 ° C imizuzu engama-30. Ngemva kokungasebenzi kwegciwane, ukukhishwa kwe-nucleic acid kwenziwa ensimbini ye-Abbott m2000 SP kusuka ku-0.5 ml VTM kusetshenziswa isistimu yokulungiselela isampula ye-Abbott m2000 DNA. ngokusho komkhiqizi. Ukukhulisa nokutholwa kwenziwa kusetshenziswa ithuluzi le-Abbott m2000 RT-PCR, futhi ukutholwa okukabili kwenziwa kuzakhi zofuzo ze-RdRp ne-N. I-ROX) kanye ne-VIC P (udayi wobunikazi) wokukhomba nokutholwa kwezilawuli zangaphakathi, okuvumela ukutholwa kanyekanye kwayo yomibili imikhiqizo yokukhulisa i-19 .
Indlela yokuthola i-amplification yale khithi isuselwe kubuchwepheshe be-RT-PCR obuyisinyathelo esisodwa. Izakhi zofuzo ze-ORF1a/b ne-N zikhethwe njengezifunda ezilondoloziwe yi-Daan Gene Technology ukuze kutholwe ukukhuliswa kwesifunda okuhlosiwe. Ama-primer akhethekile nama-fluorescent probe (ama-N gene probe anelebuli ye-FAM, ORF1a/b anelebuli ye-VIC) aklanyelwe ukuthola i-SARS-CoV-2 RNA kumasampuli. Izingxube zokugcina ezihlakaniphile neziyinhloko zilungiswe ngokwengeza u-5 µl we-eluent ku-20 µl wemiksi eyinhloko kuvolumu yokugcina engu-25 µl. Ukukhulisa nokutholwa kwenziwa kanyekanye ethuluzini le-PCR lesikhathi sangempela le-ABI 750024.
Izakhi zofuzo ze-ORF1a/b kanye ne-N zitholwe kusetshenziswa i-Sansure Biotech nCoV-2019 Nucleic Acid Diagnostic Kit (ukutholwa kwe-PCR yefluorescent). Lungiselela ama-probe athile ofuzo ngalunye oluqondiwe ngokukhetha isiteshi se-FAM sesifunda se-ORF1a/b kanye nesiteshi se-ROX sofuzo lwe-N. Kule khithi yokuhlola, ama-ejenti e-eluent kanye nama-master mix reagent angezwa kanje: lungiselela i-30 µl master mix reagent kanye nesampula engu-20 µl eluted ukuze kutholwe/ukukhulisa. I-PCR ABI 750025 yesikhathi sangempela isetshenziselwe ukukhulisa/ukutholwa.
Ukuhlolwa kwe-SARS-CoV-2 BGI kuyikhithi yesikhathi sangempela se-fluorescent ye-rRT-PCR yokuxilonga i-COVID-19. Isifunda okuhlosiwe sitholakala esifundeni se-ORF1a/b se-SARS-CoV-2 genome, okuyindlela eyodwa yokuthola isakhi sofuzo. Ngaphezu kwalokho, isakhi sofuzo sokugcina indlu somuntu i-β-actin iwufuzo oluqondiwe ngaphakathi. Imiksi eyinhloko ilungiswa ngokuxuba u-20 µl we-master mix reagent kanye no-10 µl wesampula ye-RNA ekhishiwe epuletini lomthombo26. Ithuluzi le-PCR lesikhathi sangempela le-ABI 7500 fluorescent lasetshenziselwa ukukhulisa nokutholwa. Konke ukukhuliswa kwe-nucleic acid, izimo ze-PCR zokusetshenziswa kokuhlolwa ngakunye, nokutolikwa kwemiphumela kwenziwa ngokulandela imiyalelo yomkhiqizi ofanele (Ithebula 3).
Kulokhu kuhlaziya okuqhathanisayo, asizange sisebenzise indlela evamile yereferensi ukuze sinqume isivumelwano sephesenti (esihle, esibi, nesisonke) kanye neminye imingcele yokuqhathanisa yokuhlaziya okune. Ukuqhathaniswa kokuhlolwa ngakunye kwenziwa ne-CRS, kulolu cwaningo i-CRS yamiswa ngomthetho othi “noma iyiphi i-positive” futhi umphumela wanqunywa, hhayi ukuhlolwa okukodwa, sisebenzise okungenani imiphumela yokuhlola emibili efanisiwe. Ngaphezu kwalokho, esimweni sokudluliswa kwe-COVID-19, imiphumela engemihle engamanga iyingozi kakhulu kunemiphumela emihle engamanga. Ngakho-ke, ukusho ukuthi “kuhle” ngokunembe ngangokunokwenzeka kumphumela we-CRS, okungenani izivivinyo ezimbili zokuhlola kufanele zibe positive, okusho ukuthi okungenani umphumela owodwa omuhle kungenzeka uvele esivivinyweni se-EUA. Ngakho-ke, emiphumeleni emine yokuhlolwa, imiphumela yokuhlolwa emibili noma ngaphezulu enikeza umphumela ofanayo ithathwa njengepholethivu yangempela noma i-negative18,27.
Idatha yaqoqwa kusetshenziswa amafomu okukhipha idatha ahlelekile, ukufakwa kwedatha nokuhlaziya kwenziwa kusetshenziswa isofthiwe yezibalo ye-Excel kanye nenguqulo ye-SPSS 23.0 yezibalo ezichazayo. Kuhlaziywe isivumelwano sephesenti elihle, elibi, neliphelele, futhi amaphuzu e-Kappa asetshenziswa ukuze kutholwe izinga lesivumelwano sendlela ngayinye ne-CRS. Amanani e-Kappa ahunyushwa kanje: 0.01 kuya ku-0.20 esivumelwaneni esincane, 0.21 kuya ku-0.40 esivumelwaneni esijwayelekile, 0.41-0.60 esivumelwaneni esimaphakathi, 0.61-0.80 esivumelwaneni esikhulu kanye no-0.81-0.99 ngesivumelwano esiphelele28.
Ukugunyazwa kwezimiso zokuziphatha kwatholwa eNyuvesi yase-Addis Ababa futhi zonke izinqubo zokuhlola zokuhlola zalolu cwaningo zagunyazwa Ibhodi Lokubuyekeza Izimiso Zokuziphatha Lezesayensi Ye-Ethiopian Public Health Institute. Inombolo yesithenjwa yelayisensi ye-EPHI Ethics ithi EPHI/IRB-279-2020. Zonke izindlela zisetshenziswe ngokuhambisana nezincomo nezinhlinzeko Zemihlahlandlela Kazwelonke Yase-Ethiopia Ephelele Yokwelapha I-COVID-19. Ukwengeza, imvume ebhaliwe enolwazi yatholwa kubo bonke ababambiqhaza bocwaningo ngaphambi kokubamba iqhaza ocwaningweni.
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