Arụmọrụ nyocha mmụba nucleic acid anọ iji chọpụta SARS-CoV-2 na Etiopia

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Kemgbe ntiwapụ nke ọrịa coronavirus nke afọ 2019 (COVID-19), ọtụtụ nnwale nucleic acid amplification (NAATs) emeberela gburugburu ụwa wee bụrụ nyocha nyocha.Ọ bụ ezie na emepụtara ọtụtụ ule ngwa ngwa ma tinye ya na nyocha nyocha ụlọ nyocha, arụ ọrụ nke ule ndị a enyochabeghị n'ụdị dị iche iche.Ya mere, ọmụmụ ihe a bụ iji nyochaa arụmọrụ nke Abbott SARS-CoV-2, Daan Gene, BGI na Sansure Biotech assays site na iji Composite Reference Standard (CRS).Emere ọmụmụ ihe a na thelọ Ọrụ Ahụike Ọha na Etiopia (EPHI) site na 1 ruo 30 Disemba 2020. ewepụtara ihe nlele 164 nasopharyngeal site na iji ngwa QIAamp RNA mini na usoro nkwadebe sample Abbott DNA.N'ime ụdị 164, 59.1% dị mma yana 40.9% adịghị mma maka CRS. Sansure Biotech positivity dị obere ma e jiri ya tụnyere CRS (p <0.05). Sansure Biotech positivity dị obere ma e jiri ya tụnyere CRS (p <0.05). Положительные результаты Sansure Biotech были значительно ниже по сравнению с CRS (p <0,05). Nsonaazụ dị mma Sansure Biotech dị obere obere ma e jiri ya tụnyere 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）。 У Sansure Biotech было значительно меньше положительных результатов по сравнению с CRS (p <0,05). Sansure Biotech nwere nsonaazụ dị mma pere mpe ma e jiri ya tụnyere CRS (p <0.05).Nkwekọrịta zuru oke nke nyocha anọ ahụ bụ 96.3-100% tụnyere CRS.Na mgbakwunye na ọnụ ọgụgụ dị ala nke Sansure Biotech assay, arụmọrụ nke nyocha anọ ahụ fọrọ nke nta ka ọ tụnyere ya.Dị ka nke a, nyocha Sansure Biotech [Nnyocha Nchọpụta (RUO)] chọrọ nkwado ọzọ maka ojiji ya na Etiopia.N'ikpeazụ, ekwesịrị ịtụle nyocha ndị ọzọ iji nyochaa nyocha na nkwupụta ndị nrụpụta kwesịrị ekwesị.
Nnwale ụlọ nyocha bụ akụkụ nke atụmatụ Strategic Health Organisation (WHO) maka Ọrịa Coronavirus 2019 (COVID-19) Nkwado na Nzaghachi (SPRP).WHO na-adụ ọdụ na mba kwesịrị iwulite ikike ụlọ nyocha iji kwalite nkwadebe, njikwa ikpe ziri ezi, ịmụrụ anya na nzaghachi ngwa ngwa maka ihe ịma aka ahụike ọha.Nke a na-egosi na ọrụ ụlọ nyocha bụ isi ihe iji mara ọrịa na ọrịa na-efe efe nke ndị na-efe efe na-apụta na ịchịkwa mgbasa ha.
Nchọpụta nke COVID-19 chọrọ ozi gbasara ọrịa na ahụike, akara / akara nkeonwe, yana data redio na ụlọ nyocha2.Ebe ọ bụ na a kọwapụtara ntiwapụ nke COVID-19 na Wuhan, China, emepụtala ọtụtụ ule nucleic acid amplification (NAAT) azụmahịa gburugburu ụwa.A na-eji mmeghachi omume reverse polymerase chain (rRT-PCR) ezigbo oge dị ka usoro a na-eme na ọkọlọtọ maka nyocha ụlọ nyocha nke nnukwu ọrịa iku ume iku ume 2 (SARS-CoV-2) 3.Nchọpụta mkpụrụ ndụ nke SARS-CoV-2 na-adaberekarị na N (protein protein nucleocapsid), E (envelopu protein gene), na RdRp (RNA-based RNA polymerase gene) na ORF1a/b (oghere ọgụgụ 1a/b) .gene) mpaghara achọpụtara site na genome viral.A na-ahụta ha dị ka mpaghara ndị echekwara na viral genomes maka ịmata nje4.N'ime mkpụrụ ndụ ihe nketa ndị a, mkpụrụ ndụ ihe nketa RdRp na E nwere mmetụta nchọpụta nyocha dị elu, ebe mkpụrụ ndụ N nwere mmetụta nyocha dị ala5.
Arụmọrụ nke nyocha PCR nwere ike ịdịgasị iche dabere n'ihe dị iche iche dịka: reagents mmịpụta, ihe nrịbawanye/achọpụta ihe, usoro mmịpụta, ogo igwe PCR na ngwa ndị ọzọ.Ruo Eprel 2020, ihe karịrị ngwaọrụ nyocha 48 dị iche iche sitere na mba itoolu enwetala ikike iji ihe mberede (EUA) maka nyocha COVID-196.Na Etiopia, a na-eji ihe karịrị 14 ozugbo PCR nyiwe maka nchọpụta PCR nke SARS-CoV-2 na ụlọ ọrụ ahụike ọha 26, gụnyere ABI 7500, Abbott m2000, Roche 48000 na Quant-studio7.Na mgbakwunye, ngwa ule PCR dị iche iche dị, dị ka Daan Gene test, Abbott SARS-CoV-2 test, Sansure Biotech test, na SARS-CoV-2 BGI ule.Agbanyeghi na rRT-PCR nwere mmetụta nke ukwuu, ụfọdụ ndị ọrịa nwere COVID-19 na-akọ nsonaazụ na-adịghị mma n'ihi ezughị oke nke ribonucleic acid viral (RNA) na nlele n'ihi nchịkọta na-ezighi ezi, mbufe, nchekwa na njikwa na nnwale ụlọ nyocha.ọnọdụ na omume nke ndị ọrụ8.Na mgbakwunye, nlele ma ọ bụ njikwa njikwa, ntọala usoro okirikiri (Ct), yana mmeghari ya na acid nucleic ndị ọzọ ma ọ bụ SARS-CoV-2 RNA na-adịghị arụ ọrụ / fọdụrụnụ nwere ike ibute nsonaazụ ụgha na nyocha rRT-PCR9.Ya mere, o doro anya na ule PCR nwere ike ịmata ndị na-ebu nke mkpụrụ ndụ ihe nketa, ebe ọ bụ na ha enweghị ike ịmata ọdịiche dị n'etiti mkpụrụ ndụ ihe nketa na-arụ ọrụ n'ezie, ya mere ule ahụ nwere ike ịmata ndị na-ebu ya ọ bụghị ndị ọrịa10.Ya mere, ọ dị mkpa iji nyochaa arụmọrụ nyocha site na iji usoro ọkọlọtọ na ntọala anyị.Ọ bụ ezie na ọtụtụ reagents NAAT dị na Ethiopian Public Health Institute (EPHI) na mba ahụ dum, ọ nweghị ntụle ntụle maka ịdị irè ha ka akọpụtabeghị.Ya mere, ọmụmụ ihe a bu n'obi nyochaa arụmọrụ ntule nke ngwa ahịa dị maka nchọpụta SARS-CoV-2 site na rRT-PCR site na iji ụdị ụlọ ọgwụ.
Ngụkọta ndị sonyere 164 ndị a na-enyo enyo na COVID-19 sonye na ọmụmụ a.Ihe ka ọtụtụ n'ime ihe nlele sitere na ụlọ ọrụ ọgwụgwọ (118/164 = 72%), ebe ndị ọzọ 46 (28%) so na-esi na ụlọ ọrụ na-abụghị ọgwụgwọ.N'ime ndị na-esoghị ọgwụgwọ na etiti ahụ, 15 (9.1%) nwere ọrịa a na-enyo enyo na 31 (18.9%) nwere kọntaktị nke ikpe enwetara.Iri itoolu na atọ (56.7%) sonyere bụ nwoke, na pụtara (± SD) afọ ndị sonyere bụ 31.10 (± 11.82) afọ.
N'ime ọmụmụ ihe a, ekpebiela ihe dị mma na nke adịghị mma nke ule anọ maka COVID-19.Yabụ, ọnụego dị mma nke Abbott SARS-CoV-2 assay, Daan Gene 2019-nCoV assay, SARS-CoV-2 BGI assay, na Sansure Biotech 2019-nCoV assay bụ 59.1%, 58.5%, 57.9% na 55.5% n'otu n'otu. .Ọkọlọgụ ntụaka nke dị mma na nke na-adịghị mma bụ 97 (59.1%) na 67 (40.9%), n'otu n'otu (Table 1).N'ime ọmụmụ ihe a, nkọwa nke CRS dabere na iwu "ihe ọ bụla dị mma" nke sitere na nsonaazụ ule anọ, a na-ewere nsonaazụ abụọ ma ọ bụ karịa nke nyere otu nsonaazụ ahụ dị ka ezi ma ọ bụ adịghị mma.
N'ime ọmụmụ ihe a, anyị hụrụ nkwekọrịta pasent na-adịghị mma (NPA) nke 100% (95% CI 94.6-100) maka nyocha niile tụnyere CRS.Nyocha Sansure Biotechnology gosipụtara ntakịrị PPA nke 93.8% (95% CI 87.2-97.1) yana nyocha Daan Gene 2019-nCoV nwere nkwekọrịta n'ozuzu nke 99.4% (95% CI 96.6-99.9).N'ụzọ dị iche, nkwekọrịta n'ozuzu n'etiti SARS-CoV-2 BGI assay na Sansure Biotech 2019-nCoV assay bụ 98.8% na 96.3%, n'otu n'otu (Table 2).
Cohen's kappa coefficient of nkwekọrịta dị n'etiti CRS na Abbott SARS-CoV-2 nsonaazụ nyocha na-agbanwe agbanwe (K = 1.00).N'otu aka ahụ, ụkpụrụ Cohen's kappa chọpụtara site na Daan Gene 2019-nCoV, SARS-CoV-2 BGI, na Sansure Biotech 2019-nCoV kwekọkwara n'ụzọ zuru ezu na CRS (K ≥ 0.925).Na nyocha ntụle a, nnwale chi-square (Nnwale McNemar) gosiri na nsonaazụ nyocha Sansure Biotech 2019-nCoV dị nnọọ iche na nsonaazụ CRS (p = 0.031) (Table 2).
Dị ka e gosiri na fig.1 pasent nke uru Ct kacha ala (<20 Ct) nke Abbott SARS-CoV-2 assay (jikọtara RdRp na N gene) bụ 87.6% na ORF1a/b gene Ct uru nke Sansure Biotech 2019-nCoV assay gosiri na pasentị dị ala. Uru Ct (<20 Ct) bụ 50.3% yana uru Ct dị elu (36-40 Ct) bụ 3.2%. 1 pasent nke uru Ct kacha ala (<20 Ct) nke Abbott SARS-CoV-2 assay (jikọtara RdRp na N gene) bụ 87.6% na ORF1a/b gene Ct uru nke Sansure Biotech 2019-nCoV assay gosiri na pasentị dị ala. Uru Ct (<20 Ct) bụ 50.3% yana uru Ct dị elu (36-40 Ct) bụ 3.2%.Dị ka e gosiri na fig.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) na 3,2%. 1, pasent nke uru Ct kacha ala (<20 Ct) nyocha nke Abbott SARS-CoV-2 (jikọtara gene RdRp na N) bụ 87.6%, yana uru Ct nke ORF1a/b gene analysis nke Sansure Biotech 2019-nCoV gosipụtara. na pasent nke uru Ct dị ala (<20 Ct) ruru 50.3%, na ọnụ ahịa dị elu Ct (36-40 Ct) bụ 3.2%.如 1 所 示 所 所 所 所 所 所 所-2 检测 (结合 Rdrp 和 N 低 最 低 ct 值 ct) 为 87.6%, sov1A / b 基因 ct值(< 20 Ct) 的百分比为50.3%，高Ct 值(36–40 Ct) 的百分比为3.2%. Dị ka egosiri na eserese 1, pasent uru Ct kacha ala (<20 Ct) nke ule Abbott SARS-CoV-2 (nchịkọta RdRp na N gene) bụ 87.6%, uru ORF1a/b gene Ct nke Sansure Biotech 2019-nCoV ule. na-egosi obere Ct值 (<20 Ct) 的 pasentị bụ 50.3%, 高Ct 值(36–40 Ct) 的 pasenti bụ 3.2%. Как показано на рисунке 1, анализ Abbott SARS-CoV-2 (сочетающий гены RdRp и N) имел самое низкое процентное значение Ct (< 20 Ct) в размере 87,6%, а значение Ct гена ORF1a/b в исследовании Sansure Biotech 2019 - Анализ nCoV показал низкий Ct. Dịka egosiri na eserese 1, nyocha Abbott SARS-CoV-2 (ijikọta RdRp na mkpụrụ ndụ N) nwere uru Ct kacha ala (<20 Ct) na 87.6%, ebe uru Ct nke ORF1a/b gene na Sansure. Ọmụmụ Biotech 2019 - Nyocha nke nCoV gosipụtara obere Ct. Процент значений (<20 Ct) составил 50.3%, а процент высоких значений Ct (36-40 Ct) составил 3,2%. Pasent nke ụkpụrụ (<20 Ct) bụ 50.3%, yana pasent nke ụkpụrụ Ct dị elu (36-40 Ct) bụ 3.2%.Nnwale Abbott SARS-CoV-2 B dekọtara ụkpụrụ Ct karịa 30. N'aka nke ọzọ, na BGI SARS-CoV-2 assay ORF1a/b gene nwere ọnụọgụ Ct dị elu (> 36 Ct) bụ 4% (Fig 1). N'aka nke ọzọ, na BGI SARS-CoV-2 assay ORF1a/b gene nwere ọnụọgụ Ct dị elu (> 36 Ct) bụ 4% (Fig 1). Сдругой стороны, в анализе BGI SARS-CoV-2 ген ORF1a/b имел высокое значение Ct (> 36 Ct), процент которого сост. N'aka nke ọzọ, na nyocha nke BGI SARS-CoV-2 gene ORF1a/b nwere uru Ct dị elu (> 36 Ct), pasent ya bụ 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） N'aka nke ọzọ, na nchọpụta BGI SARS-CoV-2, pasent nke ORF1a/b gene nwere uru Ct dị elu (> 36 Ct) bụ 4% (Ọnụ ọgụgụ 1). Сдругой стороны, в анализе BGI SARS-CoV-2 процент генов ORF1a/b с высокими значениями Ct (> 36 Ct) составил 4% (ри). N'aka nke ọzọ, na nyocha BGI SARS-CoV-2, pasentị nke mkpụrụ ndụ ihe nketa ORF1a/b nwere ụkpụrụ Ct dị elu (> 36 Ct) bụ 4% (Fig 1).
N'ime ọmụmụ ihe a, anyị were 164 sample nasopharyngeal.Maka ụdị nyocha ọ bụla, a na-eme ikewapụ RNA na nkwalite site na iji usoro na ngwa ndị nrụpụta dị iche iche tụrụ aro.
Ọmụmụ ihe a gosipụtara na ule Abbott maka SARS-CoV-2 nwere otu arụmọrụ nchọpụta dị ka CRS, yana 100% ziri ezi, adịghị mma na nkwenye zuru oke.Nkwekọrịta kappa Cohen bụ 1.00, na-egosi nkwekọrịta zuru oke na CRS.Nnyocha yiri nke ahụ nke Mahadum Washington dị na US chọpụtara na ọgụgụ isi na nkọwapụta nke ule Abbott maka SARS-CoV-2 bụ 93% na 100%, n'otu n'otu, ma e jiri ya tụnyere nyocha nke ụlọ nyocha kpebiri (LDA) nke CDC. .11. The Abbott SARS-CoV-2 usoro nchọpụta usoro dabeere na imekotaotuugbo nchọpụta N na RdRp mkpụrụ ndụ ihe nketa, dị ka ma mkpụrụ ndụ ihe nketa na-enwe mmetụta karị, ibelata ụgha negatives12.Nnyocha e mere na Vienna, Austria gosikwara na nnukwu mpempe akwụkwọ mmịpụta na nchọpụta eluent ebelatala mmetụta dilution na mmụba nrịbama13.Yabụ, egwuregwu zuru oke nke Abbott maka nyocha SARS-CoV-2 nwere ike jikọta ya na sistemụ nchọpụta ikpo okwu nke na-achọpụta mkpụrụ ndụ ihe nketa n'otu oge, na-ewepụta ọnụọgụ dị ukwuu (0.5 ml), ma na-eji nnukwu eluent (40 µl).
Nsonaazụ anyị gosikwara na arụmọrụ nchọpụta nke nyocha mkpụrụ ndụ ihe nketa Daan fọrọ nke nta ka ọ bụrụ otu nke CRS.Nke a dabara na ọmụmụ14 emere na Mahadum Anhui dị na Huainan, China, yana nkwuputa onye nrụpụta nke nkwekọrịta dị mma 100%.N'agbanyeghị akụkọ na-egosi nsonaazụ na-agbanwe agbanwe, otu nlele bụ ụgha na-adịghị mma mgbe anwalechara otu eluate ahụ, mana ọ dị mma na nyocha Abbott SARS-CoV-2 na Sansure Biotech nCoV-2019.Nke a na-egosi na enwere ike inwe mgbanwe dị na nsonaazụ n'ofe ụdị nyocha dị iche iche. Ka o sina dị, n'ime ọmụmụ ihe e mere na China15, nsonaazụ nke Daan Gene assay dị nnọọ iche (p <0.05) ma e jiri ya tụnyere nyocha nyocha ha akọwapụtara. Ka o sina dị, n'ime ọmụmụ ihe e mere na China15, nsonaazụ nke Daan Gene assay dị nnọọ iche (p <0.05) ma e jiri ya tụnyere nyocha nyocha ha akọwapụtara. Теm ne mene, в исследовании, проведенnom в Китае 15, rezultat analiza Daan Gene значительно отличался, 5. Agbanyeghị, na nyocha na China15, nsonaazụ nyocha Daan Gene dị nnọọ iche (p <0.05) site na nyocha ntụaka ụlọ nyocha ha., 在 在 中国 基因 基因 基因 基因 基因 其 其 验室 验室 参考 参考 有 有 显着 显着 显着 显着 显着 (p <0.05).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的参考检测眾果与其实验室定义的参考检测縷参参考检测縸术縷来0. Однако в исследовании, проведенном в Китае15, результаты генетического теста Daan значительно отличались (p < 0,05) по сравнению с его эталонным лабораторным тестом. Agbanyeghị, na nyocha na China15, nsonaazụ mkpụrụ ndụ mkpụrụ ndụ Daan dị iche (p <0.05) ma e jiri ya tụnyere nyocha ụlọ nyocha ya.Nkwekọrịta a nwere ike ịbụ n'ihi uche nke nyocha ntụaka iji chọpụta SARS-CoV-2, ọmụmụ ihe ọzọ nwere ike ịdị mkpa iji chọpụta ihe kpatara ya.
Na mgbakwunye, ọmụmụ anyị tụlere arụmọrụ atụnyere SARS-CoV-2 BGI na CRS, na-egosi nkwekọrịta pasentị dị mma nke ọma (PPA = 97.9%), nkwekọrịta pasent na-adịghị mma (NPA = 100%), yana nkwekọrịta pasentị site na okike. OPA).).= 98.8%).Ụkpụrụ Cohen's Kappa gosipụtara nkwekọrịta dị mma (K = 0.975).Nnyocha na Netherlands16 na China15 egosila nsonaazụ na-agbanwe agbanwe.Nnwale SARS-CoV-2 BGI bụ otu mkpụrụ ndụ ihe nketa (ORF1a/b) na-eji 10 µl amplification/nchọpụta eluate.N'agbanyeghị nkwekọrịta ndekọ ọnụ ọgụgụ dị mma na nsonaazụ ntụaka anyị, nyocha ahụ tụfuru ihe nlele abụọ dị mma (1.22%) nke mkpokọta.Nke a nwere ike inwe nnukwu mmetụta ụlọ ọgwụ maka mgbanwe mgbasa ozi na ma ndị ọrịa ma ọkwa obodo.
Ntụle ntụnyere ọzọ gụnyere n'ime ọmụmụ ihe a bụ nyocha Sansure Biotech nCoV-2019 rRT-PCR (RUO);Pasent egwuregwu n'ozuzu ya bụ 96.3%.Akwụsịkwara ike nke nkwekọrịta site na uru Cohen's Kappa, nke bụ 0.925, na-egosi nkwekọrịta zuru oke na CRS.Ọzọ, nsonaazụ anyị yiri ọmụmụ ihe emere na Central South University na Changsha, China, yana na ngalaba ụlọ nyocha Clinical nke Liuzhou People's Hospital, Liuzhou City, China17. Ọ bụ ezie na e dekọrọ nkwekọrịta ndekọ ọnụ ọgụgụ dị mma dị n'elu, ule chi-square (MacNemar test) gosiri na nsonaazụ Sansure Biotech assay nwere nnukwu ọdịiche dị ịrịba ama tụnyere CRS (p <0.005). Ọ bụ ezie na e dekọrọ nkwekọrịta ndekọ ọnụ ọgụgụ dị mma dị n'elu, ule chi-square (MacNemar test) gosiri na nsonaazụ Sansure Biotech assay nwere nnukwu ọdịiche dị ịrịba ama tụnyere 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). Ọ bụ ezie na e dekọrọ nkwekọrịta ndekọ ọnụ ọgụgụ dị mma dị n'elu, ule chi-square (McNemar test) gosiri na nsonaazụ nke Sansure Biotech assay nwere ọdịiche dị ịrịba ama nke ọnụ ọgụgụ ma e jiri ya tụnyere CRS (p <0.005).记录 记录 了 了 上述 卡方 卡方 卡方 卡方 卡方 卡方 卡方 卡方 卡方 卡方 卡方 卡方, sorise biotach 检测 结果 结果 crs 结果 crs 相比 统计学 统计学 统计学 0.005).记录 了 了 了 了 上述 了 统计 统计 (Macnemar 检验 表明, songeech 检测 结果 与 Crech 相比 具有 显着 (p <0.1) .............. ……)) Несмотря на отмеченное выше хорошее статистическое соответствие, критерий хи-квадрат (критерий Макнемара) показал статистически значимую разницу (p < 0,005) между анализом Sansure Biotech и CRS. N'agbanyeghị ezigbo nkwekọrịta ndekọ ọnụ ọgụgụ ahụ e kwuru n'elu, ule chi-square (McNemar test) gosiri ọdịiche dị ịrịba ama (p <0.005) n'etiti Sansure Biotech assay na CRS.Achọpụtara ihe nlele isii (3.66%) ka ọ bụrụ ihe na-adịghị mma ma e jiri ya tụnyere CRS (Ntinye mgbakwunye 1);nke a dị ezigbo mkpa, ọkachasị n'ihi usoro mgbasa ozi nke nje.Ihe data dị n'elu na-akwadokwa ọnụọgụ nchọpụta dị ala15.
N'ime ọmụmụ ihe a, a na-ekpebi ụkpụrụ Ct maka nyocha ọ bụla na ikpo okwu nke ọ bụla, yana ọnụ ahịa Ct kacha ala akọwara na nyocha Abbott SARS-CoV-2.Nsonaazụ a nwere ike jikọta na sistemu nnwale mkpụrụ ndụ ihe nketa Abbott jikọtara ọnụ maka nchọpụta SARS-CoV-2.Ya mere, dị ka eserese 1, 87.6% nke Abbott SARS-CoV-2 nsonaazụ nwere Ct ụkpụrụ n'okpuru 20. Naanị ọnụ ọgụgụ dị nta nke sample sample (12.4%) nọ na 20-30 nso.Edekọghị ụkpụrụ Ct karịrị 30.Na mgbakwunye na ojiji Abbott jiri usoro nnwale mkpụrụ ndụ ihe nketa SARS-CoV-2 panel, nsonaazụ a nwere ike jikọta ya na njedebe nchọpụta dị ala (32.5 RNA / mL) 18, nke ji okpukpu atọ dị ala karịa obere ụlọ ọrụ nke 100 RNA. /ml.ml) 19.
Ọmụmụ ihe a nwere oke ụfọdụ: nke mbụ, anyị enweghị usoro ọkọlọtọ/ntụgharị aka [dị ka ibu nje ma ọ bụ ule ụlọ nyocha ndị ọzọ (LDA)] n'ihi enweghị akụrụngwa.Nke abuo, ihe nlere anya nile ejiri mee ihe n'ọmụmụ ihe a bụ swabs nasopharyngeal, ebe nsonaazụ ya adịghị adaba na ụdị ụdị ndị ọzọ, na nke atọ, nha anyị dị ntakịrị.
Ọmụmụ ihe a tụlere arụmọrụ nke nyocha anọ rRT-PCR maka SARS-CoV-2 site na iji sample nasopharyngeal.Nnwale nchọpụta niile nwere ihe fọrọ nke nta ka ọ bụrụ arụmọrụ, ewezuga nyocha Sansure Biotech. E wezụga nke ahụ, achọpụtara ọnụ ọgụgụ positivity dị ala na nyocha Sansure Biotech ma e jiri ya tụnyere CRS (p <0.05). E wezụga nke ahụ, achọpụtara ọnụ ọgụgụ positivity dị ala na nyocha Sansure Biotech ma e jiri ya tụnyere CRS (p <0.05). Кроме того, в тесте Sansure Biotech был выявлен низкий процент положительных результатов по сравнению с CRS (p <0,0). Tụkwasị na nke ahụ, ule Sansure Biotech gosipụtara pasent dị ala nke nsonaazụ dị mma ma e jiri ya tụnyere 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). Na mgbakwunye, nyocha nke Sansure Biotech nwere ọnụ ọgụgụ positivity dị ala ma e jiri ya tụnyere CRS (p <0.05).Nyocha Sansure Biotech nCoV-2019 (RUO) nke PPA, NPA na nkwekọrịta zuru oke gafere 93.5% yana ike Cohen Kappa nke uru nkwekọrịta nke 0.925.N'ikpeazụ, Sansure Biotech Assay (RUO) chọrọ nkwado ọzọ maka ojiji na Etiopia, yana nyocha ọzọ kwesịrị ịtụle iji nyochaa nkwupụta sitere n'aka ndị nrụpụta n'otu n'otu.
E mere atụmatụ ọmụmụ ihe atụnyere n'ụlọ ọrụ ahụike anọ dị na Addis Ababa, ụlọ ọgwụ Eka Kotebe, Ụlọ Ọgwụ Ọgwụgwọ Churchka Millennium, Ụlọ Ọgwụ Zewooditu Memorial, na Ụlọ Ọgwụ Ọkachamara Ọrịa Tuberculosis St. Peter.Achịkọtara data a n'etiti Disemba 1 na 31, 2020. A na-ahọrọ ụlọ ọgwụ maka ọmụmụ ihe a nke ọma dabere na ọnụ ọgụgụ dị elu nke ikpe ha yana enwere nnukwu ụlọ ọrụ ọgwụgwọ n'obodo.N'otu aka ahụ, ngwá ọrụ, gụnyere ABI 7500 na Abbott m2000 ezigbo PCR ngwá ọrụ, ka ahọpụtara dịka ndụmọdụ nke ndị na-emepụta NAAT reagent si kwuo, a họrọkwara ngwa nchọpụta PCR anọ maka ọmụmụ ihe a, dịka ọtụtụ ụlọ nyocha na Etiopia jiri ma ọ dịkarịa ala ma ọ dịkarịa ala. anọ n’ime ha.Nnwale mkpụrụ ndụ, ule Abbott SARS-CoV-2, ule Sansure Biotech na nnwale SARS-CoV-2 BGI emere n'oge ọmụmụ ihe).
Emere nnwale SARS-CoV-2 site na 1 ruo 30 Disemba 2020 site na iji 3 ml nke Viral Transport Medium (VTM) (Technology Miraclean, Shenzhen, China) sitere na ndị mmadụ nọ na nyocha maka COVID-19 zoro aka na EPHI.Ndị na-anakọta ihe a zụrụ azụ chịkọtara sample nasopharyngeal ma ziga ya na EPHI na ngwugwu atọ.Tupu ekewapụ acid nucleic, a na-ekenye nlele ọ bụla nọmba njirimara pụrụ iche.A na-eme mmịpụta site na nlele ọ bụla ozugbo ọ bịarutere site na iji ntuziaka na ụzọ mmịpụta akpaka.Ya mere, n'ihi na akpaka mmịpụta nke Abbott m2000, 1.3 ml (gụnyere 0.8 ml nwụrụ anwụ olu na 0.5 ml mmịpụta inlet olu) nke sample e wepụtara na nke ọ bụla sample na gabiga na Abbott DNA Sample Preparation System (Abbott Molecular Inc. des Plaines). IL, USA).) Agụnyere 96 [92 samples, abụọ nchọpụta njikwa na abụọ na-abụghị template njikwa (NTC)] na-gụnyere na mkpokọta usoro (iweghachi na nchọpụta) nke abụọ agba nke SARS-CoV-2 (EUA) ozugbo.igwu ala.N'otu aka ahụ, maka mmịpụta akwụkwọ ntuziaka, jiri otu ihe atụ (maka mmịpụta akpaka na nchọpụta).Ya mere, n'oge usoro ahụ, 140 µl samples ka ewepụtara wee wepụta ya site na iji QIAamp Viral RNA Mini Kit (QIAGEN GmbH, Hilden, Germany) na batches nke 24 (gụnyere ihe nlele 20, njikwa nyocha abụọ na NTC abụọ) n'elu agba itoolu.Ejiri aka wepụta eluates dị elu wee chọpụta site na iji ABI 7500 thermal cycler site na iji SARS-CoV-2 BGI assay, Daan Gene assay, na Sansure Biotech assay.
Kewapụ akpaaka na ịdị ọcha nke SARS-CoV-2 viral RNA na-agbaso ụkpụrụ ndọta ndọta site na iji ihe nrụpụta ihe nlele Abbott DNA.A na-arụ ọrụ nrụpụta ihe nlele na solubilization nke ụmụ irighiri ihe nje site na iji ncha nwere guanidine isothiocyanate iji denature protein na arụ ọrụ RNase.A na-ekewa RNA na protein site na nkewa siri ike site na iji silica, ya bụ nnu guanidinium na pH alkaline nke ihe nchekwa lysis na-akwalite njikọ nke nucleic acid na silica (SiO2).Nzọụkwụ nchacha na-ewepụ protein na irighiri ihe fọdụrụnụ iji mepụta ngwọta doro anya.RNA transperent dịpụrụ adịpụ site na microparticles sitere na silica site na iji ndọta akụrụngwa20,21.N'aka nke ọzọ, a na-eme ikewapụ akwụkwọ ntuziaka na ịdị ọcha nke RNA site na usoro kọlụm ntụgharị site na iji centrifugation kama nguzo magnet na nkewa nke microparticles na eluent.
Emere Abbott Real-Time SARS-CoV-2 Detection Test (Abbott Molecular, Inc.) dị ka ntuziaka onye nrụpụta si dị, nke natara EUA19,22 sitere na WHO na FDA.N'ime usoro iwu a, a na-eme ihe nlere anya tupu mwepụta na mmiri ịsa ahụ na 56 Celsius C maka 30 min.Mgbe nje virus kwụsịrị, a na-eme mmịpụta nucleic acid na ngwa Abbott m2000 SP sitere na 0.5 ml VTM site na iji usoro nkwadebe ihe nlele DNA Abbott m2000.dị ka emeputa.Emere mmụba na nchọpụta site na iji ngwa Abbott m2000 RT-PCR, na nchọpụta abụọ ka emere maka mkpụrụ ndụ ihe nketa RdRp na N.ROX) na VIC P (ihe e ji esiji eme ihe) maka ikwado na ịchọpụta njikwa n'ime, na-enye ohere ịchọpụta n'otu oge nke ngwaahịa nkwalite abụọ 19.
Usoro nchọpụta mmụba nke ngwa a dabere na teknụzụ RT-PCR otu nzọụkwụ.Ahọpụtara mkpụrụ ndụ ihe nketa ORF1a/b na N ka mpaghara Daan Gene Teknụzụ chekwara iji chọpụta nkwalite mpaghara ebumnuche.Emebere ihe izizi na ihe nyocha fluorescent (N nyocha mkpụrụ ndụ nke akpọrọ FAM, ORF1a/b nyocha nke akpọrọ VIC) iji chọpụta SARS-CoV-2 RNA na nlele.Emebere eluent ikpeazụ na ngwakọta nna ukwu site n'ịgbakwunye 5 µl nke eluent na 20 µl nke ngwakọta nna ukwu na olu ikpeazụ nke 25 µl.Emere mmụba na nchọpụta n'otu oge na ngwa PCR ABI 750024 ezigbo oge.
Achọpụtara mkpụrụ ndụ ihe nketa ORF1a/b na N site na iji Sansure Biotech nCoV-2019 Nucleic Acid Diagnostic Kit (nchọpụta PCR fluorescent).Kwadebe nyocha akọwapụtara maka mkpụrụ ndụ ihe mgbaru ọsọ ọ bụla site na ịhọrọ ọwa FAM maka mpaghara ORF1a/b yana ọwa ROX maka gene N.Na ngwa nyocha a, a na-agbakwunye eluent na master mix reagents dị ka ndị a: kwadebe 30 µl master mix reagent na 20 µl eluted sample maka nchọpụta / mmụba.A na-eji PCR ABI 750025 ezigbo oge maka mmụba/nchọpụta.
Nnwale SARS-CoV-2 BGI bụ ngwa fluorescent ozugbo rRT-PCR maka nyocha nke COVID-19.Mpaghara ebumnuche dị na mpaghara ORF1a/b nke genome SARS-CoV-2, nke bụ otu usoro nchọpụta mkpụrụ ndụ ihe nketa.Na mgbakwunye, mkpụrụ ndụ ihe nketa β-actin bụ mkpụrụ ndụ ihe eji ahazi n'ime.A na-akwado ngwakọta nna ukwu site na ịgwakọta 20 µl nke ihe nrụpụta ihe nrụpụta na 10 µl nke ihe nlele RNA ewepụtara na efere ọma26.Ejiri ngwa PCR ABI 7500 fluorescent quantitative ezigbo oge maka mmụba na nchọpụta.All nucleic acid amplification, PCR na-agba ọsọ ọnọdụ maka nyocha ọ bụla, na nkọwa nke nsonaazụ ka emere dịka ntuziaka onye nrụpụta si dị (Table 3).
Na ntụle ntụnyere a, anyị ejighị usoro ntụaka iji chọpụta nkwekọrịta pasentị (nke dị mma, nke na-adịghị mma na n'ozuzu) na ihe atụnyere ndị ọzọ maka nyocha anọ ahụ.A na-eji CRS tụnyere nyocha ọ bụla, n'ime ọmụmụ ihe a, e debere CRS site na iwu "ihe ọ bụla dị mma" ma ekpebie nsonaazụ ya, ọ bụghị site na otu ule, anyị jiri opekata mpe abụọ dabara na nsonaazụ ule.Na mgbakwunye, n'ihe gbasara mgbasa ozi COVID-19, nsonaazụ ọjọọ ụgha dị ize ndụ karịa nsonaazụ ụgha.Ya mere, ikwu "ezigbo" dịka o kwere mee site na nsonaazụ CRS, opekata mpe ule nyocha abụọ ga-abụrịrị nke ọma, nke pụtara na ọ dịkarịa ala otu nsonaazụ dị mma nwere ike ịpụta site na nyocha EUA.Yabụ, n'ime nsonaazụ ule anọ, a na-ahụta nsonaazụ abụọ ma ọ bụ karịa nke na-enye otu nsonaazụ ahụ ka ọ dị mma ma ọ bụ adịghị mma18,27.
A na-anakọta data site n'iji ụdị nchịkọta data ahaziri ahazi, ntinye data na nyocha bụ site na iji sọftụ ọnụ ọgụgụ Excel yana ụdị SPSS 23.0 maka ọnụ ọgụgụ nkọwa.A tụlere nkwekọrịta pasentị dị mma, adịghị mma na n'ozuzu ya, wee jiri akara Kappa chọpụta ogo nkwekọrịta nke usoro ọ bụla na CRS.A na-akọwa ụkpụrụ Kappa dị ka ndị a: 0.01 ruo 0.20 maka nkwekọrịta dị nro, 0.21 ruo 0.40 maka nkwekọrịta izugbe, 0.41-0.60 maka nkwekọrịta na-agafeghị oke, 0.61-0.80 maka nnukwu nkwekọrịta na 0.81-0.99 maka nkwekọrịta zuru oke28.
Enwetara nchapụta ụkpụrụ omume site na Mahadum Addis Ababa na ụkpụrụ nnwale niile maka ọmụmụ ihe a bụ ndị Ethiopian Public Health Institute's Scientific Ethics Review Board kwadoro.Nọmba ntụaka maka ikikere ụkpụrụ omume EPHI bụ EPHI/IRB-279-2020.Ejiri usoro niile dabere na ntụnye na ntụzịaka nke ntuziaka zuru oke nke mba Etiopia maka ọgwụgwọ COVID-19.Na mgbakwunye, enwetara nkwenye ederede ederede site na ndị niile sonyere n'ọmụmụ ihe tupu itinye aka na ọmụmụ ihe ahụ.
A na-etinye data niile enwetara ma ọ bụ nyochara n'ime ọmụmụ ihe a n'akwụkwọ akụkọ a.Data na-akwado nsonazụ nke ọmụmụ a dị site n'aka onye odee dị iche iche na arịrịọ ezi uche dị na ya.
World Health Organization.Ntụnye maka atụmatụ nnwale ụlọ nyocha maka COVID-19: Nduzi nwa oge, Maachị 21, 2020 Mba WHO/2019-nCoV/lab_testing/2020.1 (WHO, 2020).
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