Kev ua tau zoo ntawm plaub nucleic acid amplification assays los txheeb xyuas SARS-CoV-2 hauv Ethiopia

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Txij li thaum xyoo 2019 tus kab mob coronavirus (COVID-19) tshwm sim, ntau yam kev lag luam nucleic acid amplification test (NAATs) tau tsim nyob thoob ntiaj teb thiab tau dhau los ua cov qauv ntsuas. Txawm hais tias ntau qhov kev ntsuam xyuas tau tsim sai sai thiab siv rau hauv kev sim tshuaj ntsuam xyuas, qhov ua tau zoo ntawm cov kev ntsuam xyuas no tsis tau raug soj ntsuam hauv ntau qhov chaw. Yog li, qhov kev tshawb fawb no tau tsom mus rau kev ntsuas kev ua tau zoo ntawm Abbott SARS-CoV-2, Daan Gene, BGI, thiab Sansure Biotech kev soj ntsuam siv Composite Reference Standard (CRS). Txoj kev tshawb no tau ua nyob rau ntawm Ethiopian Public Health Institute (EPHI) los ntawm 1 txog 30 Lub Kaum Ob Hlis 2020. 164 cov qauv nasopharyngeal tau muab rho tawm siv QIAamp RNA cov khoom siv mini thiab Abbott DNA qauv npaj. Ntawm 164 tus qauv, 59.1% tau zoo thiab 40.9% tsis zoo rau CRS. Sansure Biotech positivity yog qhov tsawg heev piv rau CRS (p <0.05). Sansure Biotech positivity yog qhov tsawg heev piv rau CRS (p <0.05). Положительные результаты Sansure Biotech были значительно ниже по сравнению с CRS (p <0,05). Sansure Biotech cov txiaj ntsig zoo tau qis dua piv rau CRS (p <0.05).CRS 相比, Sansure Biotech 的阳性率显着较低 (p <0.05).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 tau txais txiaj ntsig zoo tsawg dua piv rau CRS (p <0.05).Qhov kev pom zoo tag nrho ntawm plaub qhov kev ntsuam xyuas yog 96.3-100% piv rau CRS. Ntxiv nrog rau qhov tsis muaj txiaj ntsig zoo ntawm Sansure Biotech kev soj ntsuam, qhov kev ua tau zoo ntawm plaub qhov kev soj ntsuam tau ze li qhov sib piv. Yog li ntawd, Sansure Biotech [Kev Tshawb Fawb Tsuas (RUO)] kev soj ntsuam yuav tsum muaj kev lees paub ntxiv rau nws siv hauv Ethiopia. Thaum kawg, kev tshawb fawb ntxiv yuav tsum tau txiav txim siab los ntsuas kev ntsuas nrog cov neeg tsim khoom tsim nyog thov.
Kev kuaj sim yog ib feem ntawm Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv Hauv Ntiaj Teb (WHO) Lub Hom Phiaj rau Tus Kab Mob Coronavirus 2019 (COVID-19) Npaj thiab Teb (SPRP). WHO qhia tias cov teb chaws yuav tsum tsim kom muaj peev xwm hauv chav kuaj los txhim kho kev npaj, tswj cov ntaub ntawv kom raug, ceev faj thiab teb sai rau cov teeb meem kev noj qab haus huv rau pej xeem. Qhov no qhia tau hais tias lub luag haujlwm ntawm lub chaw soj nstuam yog qhov tseem ceeb rau tus yam ntxwv ntawm tus kab mob thiab kis kab mob ntawm cov kab mob tshwm sim thiab tswj lawv qhov kev sib kis.
Kev kuaj mob ntawm COVID-19 yuav tsum muaj cov ntaub ntawv kis mob thiab kev kho mob, cov tsos mob ntawm tus kheej / cov cim qhia, thiab cov ntaub ntawv xov tooj cua thiab chaw kuaj mob 2. Txij li thaum COVID-19 tau tshaj tawm hauv Wuhan, Tuam Tshoj, ntau qhov kev lag luam nucleic acid amplification test (NAATs) tau tsim nyob thoob ntiaj teb. Real-time reverse transcription polymerase chain reaction (rRT-PCR) tau siv los ua ib txoj hauv kev thiab cov txheej txheem rau kev kuaj mob ntawm tus kab mob ua pa hnyav 2 (SARS-CoV-2)3. Molecular detection of SARS-CoV-2 feem ntau yog ua raws N (nucleocapsid protein gene), E (lub hnab ntawv protein gene), thiab RdRp (RNA-dependent RNA polymerase gene) noob hauv ORF1a/b (qhib nyeem ntawv ncej 1a/b) . gene) cheeb tsam txheeb xyuas los ntawm tus kab mob genome. Lawv raug suav hais tias yog cov cheeb tsam tseem ceeb uas pom muaj nyob hauv kab mob genomes rau kev paub txog tus kab mob 4. Ntawm cov noob no, cov noob RdRp thiab E muaj cov tshuaj ntsuam xyuas qhov ntsuas siab, thaum N noob muaj qhov ntsuas qis 5.
Kev ua tau zoo ntawm PCR kev soj ntsuam yuav txawv nyob ntawm ntau yam xws li: cov khoom siv rho tawm, kev nthuav dav / tshawb xyuas cov tshuaj, cov txheej txheem rho tawm, zoo ntawm PCR tshuab thiab lwm yam cuab yeej. Raws li lub Plaub Hlis 2020, ntau dua 48 cov cuab yeej kuaj mob sib txawv los ntawm cuaj lub tebchaws tau txais Kev Tso Cai Siv Kub Kub (EUA) rau kev kuaj mob COVID-196. Hauv Ethiopia, ntau dua 14 lub sijhawm PCR lub sijhawm tiag tiag yog siv rau PCR tshawb pom ntawm SARS-CoV-2 ntawm 26 lub tsev kho mob pej xeem, suav nrog ABI 7500, Abbott m2000, Roche 48000 thiab Quant-studio7. Tsis tas li ntawd, muaj ntau yam PCR test kits, xws li Daan Gene test, Abbott SARS-CoV-2 test, Sansure Biotech test, and SARS-CoV-2 BGI test. Txawm hais tias rRT-PCR muaj kev nkag siab zoo, qee cov neeg mob uas muaj COVID-19 qhia tsis tseeb cov txiaj ntsig tsis zoo vim tsis muaj cov ntawv luam ntawm tus kab mob ribonucleic acid (RNA) hauv cov qauv vim yog kev sau tsis raug, thauj, khaws cia thiab tuav, thiab kuaj hauv chav kuaj. cov xwm txheej thiab kev ua ntawm cov neeg ua haujlwm 8. Tsis tas li ntawd, cov qauv lossis kev tswj tsis raug, kev teeb tsa lub voj voog (Ct) kev teeb tsa, thiab kev sib cuam tshuam nrog lwm cov kab mob nucleic acids lossis tsis muaj zog / residual SARS-CoV-2 RNA tuaj yeem ua rau cov txiaj ntsig tsis zoo hauv rRT-PCR9 kev soj ntsuam. Yog li, nws yog qhov tseeb tias kev kuaj PCR tuaj yeem txheeb xyuas cov neeg nqa khoom ntawm cov noob caj noob ces, vim lawv tsis tuaj yeem paub qhov txawv ntawm cov kab mob kis tau tiag tiag, yog li cov kev sim tsuas tuaj yeem txheeb xyuas cov neeg nqa khoom thiab tsis yog cov neeg mob 10. Yog li ntawd, nws yog ib qho tseem ceeb rau kev ntsuam xyuas kev ua tau zoo siv cov txheej txheem hauv peb qhov chaw. Txawm hais tias muaj ntau NAAT reagents muaj nyob rau ntawm Ethiopian Public Health Institute (EPHI) thiab thoob plaws hauv lub tebchaws, tseem tsis tau muaj kev sib piv kev ntsuas ntawm lawv cov txiaj ntsig. Yog li, txoj kev tshawb fawb no tau tsom mus rau kev soj ntsuam kev sib piv ntawm cov khoom siv muag khoom muag rau kev kuaj pom ntawm SARS-CoV-2 los ntawm rRT-PCR siv cov qauv kuaj mob.
Tag nrho ntawm 164 tus neeg koom nrog xav tias COVID-19 tau suav nrog hauv txoj kev tshawb no. Feem ntau ntawm cov qauv yog los ntawm cov chaw kho mob (118/164 = 72%), thaum seem 46 (28%) cov neeg koom yog los ntawm cov chaw tsis kho. Ntawm cov neeg koom tsis tau kho nyob rau hauv qhov chaw, 15 (9.1%) muaj cov neeg mob xav tias mob thiab 31 (18.9%) muaj cov neeg mob uas tau lees paub. Cuaj caum-peb (56.7%) cov neeg koom yog txiv neej, thiab qhov nruab nrab (± SD) hnub nyoog ntawm cov neeg koom yog 31.10 (± 11.82) xyoo.
Hauv txoj kev tshawb no, qhov zoo thiab qhov tsis zoo ntawm plaub qhov kev sim rau COVID-19 tau txiav txim siab. Yog li, qhov zoo ntawm Abbott SARS-CoV-2 assay, Daan Gene 2019-nCoV assay, SARS-CoV-2 BGI assay, thiab Sansure Biotech 2019-nCoV assay yog 59.1%, 58.5%, 57.9% and 55.5% feem. . Cov qhab nia zoo thiab tsis zoo (CRS) cov qhab nia yog 97 (59.1%) thiab 67 (40.9%), ntsig txog (Table 1). Hauv txoj kev tshawb no, lub ntsiab lus ntawm CRS tau ua raws li txoj cai "txhua qhov zoo", uas tawm ntawm plaub qhov kev xeem, ob lossis ntau qhov kev xeem uas tau muab cov txiaj ntsig tib yam tau suav tias yog qhov zoo lossis qhov tsis zoo.
Hauv txoj kev tshawb no, peb pom qhov pom zoo feem pua ​​​​tsis zoo (NPA) ntawm 100% (95% CI 94.6-100) rau txhua qhov kev tshuaj ntsuam piv rau CRS. Sansure Biotechnology tsom xam pom qhov tsawg kawg nkaus PPA ntawm 93.8% (95% CI 87.2-97.1) thiab Daan Gene 2019-nCoV tsom xam tau pom zoo tag nrho ntawm 99.4% (95% CI 96.6-99.9). Nyob rau hauv sib piv, tag nrho cov kev pom zoo ntawm SARS-CoV-2 BGI assay thiab Sansure Biotech 2019-nCoV assay yog 98.8% thiab 96.3%, ntsig txog (Table 2).
Cohen's kappa coefficient ntawm kev pom zoo ntawm CRS thiab Abbott SARS-CoV-2 assay cov txiaj ntsig tau zoo ib yam (K = 1.00). Ib yam li ntawd, Cohen's kappa values ​​​​detected by Daan Gene 2019-nCoV, SARS-CoV-2 BGI, and Sansure Biotech 2019-nCoV is also fully consistent with CRS (K ≥ 0.925). Hauv qhov kev sib piv no, qhov kev sim chi-square (McNemar test) tau pom tias Sansure Biotech 2019-nCoV assay cov txiaj ntsig tau txawv ntawm CRS cov txiaj ntsig (p = 0.031) (Table 2).
Raws li qhia hauv Fig.1 feem pua ​​ntawm tus nqi qis tshaj Ct (< 20 Ct) ntawm Abbott SARS-CoV-2 assay (combined RdRp thiab N gene) yog 87.6% thiab ORF1a/b gene Ct tus nqi ntawm Sansure Biotech 2019-nCoV assay qhia tias feem pua ​​ntawm cov qis Tus nqi Ct (< 20 Ct) yog 50.3% thiab tus nqi siab Ct (36-40 Ct) yog 3.2%. 1 feem pua ​​ntawm tus nqi qis tshaj Ct (< 20 Ct) ntawm Abbott SARS-CoV-2 assay (combined RdRp thiab N gene) yog 87.6% thiab ORF1a/b gene Ct tus nqi ntawm Sansure Biotech 2019-nCoV assay qhia tias feem pua ​​ntawm cov qis Tus nqi Ct (< 20 Ct) yog 50.3% thiab tus nqi siab Ct (36-40 Ct) yog 3.2%.Raws li qhia hauv Fig.1, процент наименьшего значения Ct (< 20 Ct) анализа Abbott SARS-CoV-2 (комбинированный ген RdRp и N) чоставил 87,6нга составил 87,6 нализа 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, qhov feem pua ​​​​ntawm Ct tus nqi qis tshaj (< 20 Ct) kev tshuaj ntsuam ntawm Abbott SARS-CoV-2 (combined gene RdRp and N) yog 87.6%, thiab tus nqi Ct ntawm ORF1a/b gene analysis ntawm Sansure Biotech 2019-nCoV qhia. tias feem pua ​​​​ntawm tus nqi qis Ct (< 20 Ct) suav txog 50.3%, thiab tus nqi siab Ct (36-40 Ct) suav txog 3.2%.如图1 所示，Abbott SARS-CoV-2 检测（结合RdRp 和N 基因）的最低Ct 值百的分比（< 20 Ct ）为87.1 浣 1 Biotechnology/S b 基因Ct 值显示低 Ct值(<20 Ct) 的百分比为50.3%, 高Ct 值(36–40 Ct) 的百分比为3.2%. Raws li pom hauv daim duab 1, qhov qis tshaj Ct tus nqi feem pua ​​(< 20 Ct) ntawm Abbott SARS-CoV-2 test (combination of RdRp and N gene) is 87.6%, the ORF1a/b gene Ct value of Sansure Biotech 2019-nCoV test qhia tau tias qis Ct值(< 20 Ct) 的 feem pua ​​yog 50.3%, 高Ct 值(36–40 Ct) 的 feem pua ​​yog 3.2%. Как показано на рисунке 1, анализ Abbott SARS-CoV-2 (сочетающий гены RdRp и N) имел самое низкое процентное зроцентное зрни 8 Cна 7,6%, а значение Ct гена ORF1a/b в исследовании Sansure Biotech 2019 - Анализ nCoV показал низкий Ct. Raws li pom hauv daim duab 1, Abbott SARS-CoV-2 assay (combining the RdRp and N genes) muaj qhov feem pua ​​​​Ct qis tshaj (< 20 Ct) ntawm 87.6%, thaum Ct tus nqi ntawm ORF1a/b gene hauv Sansure Biotech 2019 txoj kev tshawb fawb - Kev tsom xam ntawm nCoV pom qhov qis Ct. Процент значений (< 20 Ct) составил 50,3%, а процент высоких значений Ct (36–40 Ct) составил 3,2%. Qhov feem pua ​​​​ntawm cov txiaj ntsig (< 20 Ct) yog 50.3%, thiab feem pua ​​​​ntawm cov txiaj ntsig siab Ct (36-40 Ct) yog 3.2%.Abbott SARS-CoV-2 B test recorded Ct values ​​above 30. Ntawm qhov tod tes, ntawm BGI SARS-CoV-2 assay ORF1a/b gene muaj Ct tus nqi siab (> 36 Ct) feem pua ​​​​yog 4% (Fig. 1). Ntawm qhov tod tes, ntawm BGI SARS-CoV-2 assay ORF1a/b gene muaj Ct tus nqi siab (> 36 Ct) feem pua ​​​​yog 4% (Fig. 1). С другой стороны, в анализе BGI SARS-CoV-2 ген ORF1a/b имел высокое значение Ct (> 36 Ct), процент которлого 1 сосоророго сосоророго. Ntawm qhov tod tes, hauv kev txheeb xyuas ntawm BGI SARS-CoV-2 gene ORF1a/b muaj tus nqi Ct siab (> 36 Ct), feem pua ​​​​ntawm cov uas yog 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）. Ntawm qhov tod tes, hauv BGI SARS-CoV-2 kuaj pom, feem pua ​​​​ntawm ORF1a/b gene nrog tus nqi Ct siab (> 36 Ct) yog 4% (Daim duab 1). С другой стороны, в анализе BGI SARS-CoV-2 процент генов ORF1a/b с высокими значениями Ct (>36 Ct) составил. 4%. Ntawm qhov tod tes, hauv BGI SARS-CoV-2 tsom xam, feem pua ​​​​ntawm ORF1a/b cov noob caj noob ces nrog cov Ct siab (> 36 Ct) yog 4% (Fig. 1).
Hauv txoj kev tshawb no, peb tau coj 164 tus qauv nasopharyngeal. Rau txhua hom kev ntsuam xyuas, RNA cais tawm thiab nthuav dav tau ua los ntawm cov txheej txheem thiab cov khoom siv pom zoo los ntawm cov tuam txhab tsim khoom.
Txoj kev tshawb no pom tau tias Abbott qhov kev sim rau SARS-CoV-2 muaj qhov kev kuaj pom zoo ib yam li CRS, nrog 100% qhov zoo, tsis zoo, thiab tag nrho kev sib haum xeeb. Cohen qhov kev pom zoo kappa yog 1.00, qhia txog kev pom zoo tag nrho nrog CRS. Ib txoj kev tshawb fawb zoo sib xws los ntawm University of Washington hauv Teb Chaws Asmeskas pom tias tag nrho rhiab heev thiab qhov tshwj xeeb ntawm Abbott test rau SARS-CoV-2 yog 93% thiab 100%, feem, piv rau kev kuaj ntsuas (LDA) ntawm CDC. . 11. Abbott SARS-CoV-2 detection system yog ua raws li kev tshawb nrhiav ib txhij ntawm N thiab RdRp cov noob, vim tias ob lub noob muaj kev nkag siab ntau dua, txo qis qhov tsis muaj tseeb 12. Ib txoj kev tshawb fawb hauv Vienna, Austria kuj tau qhia tias qhov loj ntawm cov qauv coj mus kuaj thiab kuaj pom qhov ntim tau txo qis cov teebmeem dilution thiab ua kom pom kev ua tau zoo13. Yog li, Abbott qhov kev sib tw zoo tshaj plaws rau SARS-CoV-2 kev soj ntsuam tuaj yeem cuam tshuam nrog lub platform nrhiav kom tau ib txhij kuaj cov noob caj noob ces, rho tawm ntau cov qauv (0.5 ml), thiab siv ntau qhov eluent (40 µl).
Peb cov txiaj ntsig kuj tau pom tias qhov kev kuaj pom ntawm Daan caj ces yuav luag zoo ib yam li CRS. Qhov no yog raws li kev tshawb fawb 14 ua nyob rau hauv Anhui University hauv Huainan, Tuam Tshoj, thiab cov chaw tsim khoom thov ntawm 100% kev pom zoo zoo. Txawm hais tias cov lus ceeb toom ntawm cov txiaj ntsig zoo ib yam, ib qho piv txwv yog qhov tsis zoo tom qab rov kuaj dua tib lub ntsiab lus, tab sis tau zoo hauv Abbott SARS-CoV-2 thiab Sansure Biotech nCoV-2019 assays. Qhov no qhia tau tias yuav muaj qhov sib txawv ntawm cov txiaj ntsig ntawm ntau hom kev ntsuas. Txawm li cas los xij, hauv txoj kev tshawb fawb tau ua nyob rau hauv Suav teb 15, qhov tshwm sim ntawm Daan Gene qhov kev ntsuam xyuas tau sib txawv heev (p <0.05) piv rau lawv qhov kev soj ntsuam kuaj mob. Txawm li cas los xij, hauv txoj kev tshawb fawb tau ua nyob rau hauv Suav teb 15, qhov tshwm sim ntawm Daan Gene qhov kev ntsuam xyuas tau sib txawv heev (p <0.05) piv rau lawv qhov kev soj ntsuam kuaj mob. Тем не менее, в исследовании, проведенном в Китае15, результат анализа Daan Gene значительно отличался отличался 5 отличался (p <отначительно) эталонного анализа. Txawm li cas los xij, hauv kev tshawb fawb hauv Suav teb 15, Daan Gene cov txiaj ntsig kev tshuaj ntsuam tau sib txawv heev (p <0.05) los ntawm lawv qhov kev soj ntsuam kev soj ntsuam.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浀緾演。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浀緾比。 Однако в исследовании, проведенном в Китае15, результаты генетического теста Daan значительно отль5сни 0 спнечительно отльчительно го эталонным лабораторным тестом. Txawm li cas los xij, hauv kev tshawb fawb hauv Suav teb 15, cov txiaj ntsig ntawm Daan qhov kev sim tshuaj caj ces tau txawv txav (p <0.05) piv rau nws qhov kev sim tshuaj ntsuam xyuas.Qhov tsis sib xws no yuav yog vim qhov kev nkag siab ntawm qhov kev siv tshuaj ntsuam xyuas kom pom SARS-CoV-2, thiab kev tshawb fawb ntxiv yuav yog qhov tseem ceeb los txiav txim qhov ua rau.
Tsis tas li ntawd, peb txoj kev tshawb fawb tau soj ntsuam qhov kev sib piv ntawm SARS-CoV-2 BGI assay nrog CRS, qhia pom zoo feem pua ​​​​ntawm kev pom zoo (PPA = 97.9%), qhov tsis zoo feem pua ​​​​pom zoo (NPA = 100%), thiab tag nrho cov feem pua ​​pom zoo los ntawm poj niam txiv neej ( OPA). ). = 98.8%). Cohen's Kappa qhov tseem ceeb tau pom zoo pom zoo (K = 0.975). Kev tshawb fawb hauv Netherlands16 thiab China15 tau pom cov txiaj ntsig zoo ib yam. SARS-CoV-2 BGI test is a single gene (ORF1a/b) detection test using 10 µl amplification/detection eluate. Txawm hais tias qhov kev pom zoo ntawm cov ntaub ntawv pov thawj zoo nrog peb cov txiaj ntsig siv, qhov kev tshuaj ntsuam tau plam ob qhov qauv zoo (1.22%) ntawm tag nrho cov qauv. Qhov no tuaj yeem muaj qhov cuam tshuam loj heev rau kev kis tus kabmob ntawm ob tus neeg mob thiab hauv zej zog.
Lwm qhov kev sib piv nrog rau hauv txoj kev tshawb no yog Sansure Biotech nCoV-2019 rRT-PCR (RUO) assay; tag nrho qhov sib tw feem pua ​​yog 96.3%. Lub zog ntawm kev pom zoo kuj tau txiav txim siab los ntawm Cohen tus nqi Kappa, uas yog 0.925, qhia tag nrho cov lus pom zoo nrog CRS. Ntxiv dua thiab, peb cov txiaj ntsig zoo ib yam rau cov kev tshawb fawb tau ua nyob rau hauv Central South University hauv Changsha, Tuam Tshoj, thiab ntawm Lub Tsev Haujlwm Saib Xyuas Kev Kho Mob ntawm Liuzhou People's Hospital, Liuzhou City, China17. Txawm hais tias qhov kev sib raug zoo saum toj no tau sau tseg, qhov kev xeem chi-square (MacNemar test) tau pom tias qhov txiaj ntsig ntawm Sansure Biotech assay tau muaj qhov sib txawv tseem ceeb piv rau CRS (p <0.005). Txawm hais tias qhov kev sib raug zoo saum toj no tau sau tseg, qhov kev xeem chi-square (MacNemar test) tau pom tias qhov txiaj ntsig ntawm Sansure Biotech assay tau muaj qhov sib txawv tseem ceeb piv rau CRS (p <0.005). Несмотря на то, что было зафиксировано указанное выше хорошее статистическое соответствие, критерий ра) показал, что результат анализа Sansure Biotech имеет статистически значимое различие по сравнению с CRS,00 (p <0). Txawm hais tias qhov kev pom zoo ntawm cov ntaub ntawv sau tseg saum toj no tau sau tseg, qhov kev xeem chi-square (McNemar test) tau pom tias qhov tshwm sim ntawm Sansure Biotech assay muaj qhov sib txawv tseem ceeb piv rau 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 检絋的结果侮 CRS着差异 (p <0.005).尽管记录了 上述良好统计 一致性，但检验（（macnemar 检验表明，， sansure biotech 检渋 盎 检渋 盎 盎着 (p <0.005. . . . . . . . . . . . . . ... ..)))) Несмотря на отмеченное выше хорошее статистическое соответствие, критерий хи-квадрат (критерий ка Мазсатам значимую разницу (p < 0,005) между анализом Sansure Biotech thiab CRS. Txawm hais tias qhov kev pom zoo ntawm cov ntaub ntawv sau tseg saum toj no, qhov kev xeem chi-square (McNemar test) tau pom qhov sib txawv tseem ceeb (p <0.005) ntawm Sansure Biotech assay thiab CRS.Rau qhov qauv (3.66%) tau pom tias yog qhov tsis zoo uas tsis muaj tseeb piv rau CRS (Cov Lus Qhia Ntxiv 1); qhov no tseem ceeb heev, tshwj xeeb tshaj yog muab cov kev hloov pauv ntawm kev kis tus kabmob. Cov ntaub ntawv saum toj no kuj txhawb nqa qhov ntsuas qis qis 15.
Hauv txoj kev tshawb no, Ct qhov tseem ceeb tau txiav txim siab rau txhua qhov kev ntsuam xyuas thiab cov txheej txheem sib tham, nrog rau qhov qis tshaj tus nqi Ct qhia hauv Abbott SARS-CoV-2 assay. Cov txiaj ntsig no tuaj yeem cuam tshuam nrog Abbott lub simultaneous sib xyaw ua ke kev kuaj kab mob rau kev kuaj pom ntawm SARS-CoV-2. Yog li ntawd, raws li daim duab 1, 87.6% ntawm Abbott SARS-CoV-2 cov txiaj ntsig tau muaj Ct qhov tseem ceeb hauv qab 20. Tsuas yog qee qhov piv txwv me me ntawm cov txiaj ntsig (12.4%) nyob hauv 20-30 ntau yam. Ct qhov tseem ceeb tshaj 30 tsis tau sau tseg. Ntxiv rau Abbott txoj kev siv SARS-CoV-2 vaj huam sib luag kev kuaj kab mob, qhov tshwm sim no yuav cuam tshuam nrog qhov kev kuaj pom qis dua (32.5 RNA cov ntawv luam / mL) 18, uas yog peb zaug qis dua lub tuam txhab qis qis ntawm 100 RNA luam. /ml. ml) 19.
Txoj kev tshawb no muaj qee qhov kev txwv: ua ntej, peb tsis muaj cov txheej txheem / kev siv cov txheej txheem [xws li cov kab mob kis los yog lwm yam kev kuaj sim (LDA)] vim tsis muaj peev txheej. Qhov thib ob, tag nrho cov qauv siv hauv txoj kev tshawb no yog nasopharyngeal swabs, thaum cov txiaj ntsig tsis siv rau lwm hom qauv, thiab peb, peb cov qauv me me.
Txoj kev tshawb no tau piv cov kev ua tau zoo ntawm plaub rRT-PCR kev soj ntsuam rau SARS-CoV-2 siv cov qauv nasopharyngeal. Txhua qhov kev kuaj xyuas pom muaj ze li qhov ua tau zoo sib xws, tshwj tsis yog Sansure Biotech assay. Tsis tas li ntawd, tus nqi qis qis tau raug txheeb xyuas hauv Sansure Biotech assay piv rau CRS (p <0.05). Tsis tas li ntawd, tus nqi qis qis tau raug txheeb xyuas hauv Sansure Biotech assay piv rau CRS (p <0.05). Кроме того, в тесте Sansure Biotech был выявлен низкий процент положительных результатов по сравнению с CRS (p <0). Tsis tas li ntawd, Sansure Biotech xeem tau pom qhov feem pua ​​​​ntawm cov txiaj ntsig zoo piv rau CRS (p <0.05).此外, CRS 相比, Sansure Biotech 检测的阳性率较低(p <0.05).此外, 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). Tsis tas li ntawd, Sansure Biotech assay muaj tus nqi qis dua piv rau CRS (p <0.05).Sansure Biotech nCoV-2019 (RUO) tsom xam ntawm PPA, NPA thiab tag nrho cov lus pom zoo tshaj 93.5% nrog Cohen Kappa lub zog ntawm daim ntawv cog lus tus nqi ntawm 0.925. Thaum kawg, Sansure Biotech Assay (RUO) xav tau kev lees paub ntxiv rau kev siv hauv Ethiopia, thiab kev tshawb fawb ntxiv yuav tsum raug txiav txim siab los ntsuas kev thov los ntawm cov neeg tsim khoom.
Kev sib piv kev kawm tsim tau ua nyob rau ntawm plaub lub tsev kho mob hauv Addis Ababa, Tsev Kho Mob Eka Kotebe, Millennium Church Treatment Center, Zewooditu Memorial Hospital, thiab St. Peter's Tuberculosis Specialist Hospital. Cov ntaub ntawv tau sau thaum lub Kaum Ob Hlis 1 thiab 31, 2020. Cov chaw kho mob rau txoj kev tshawb no tau raug xaiv los ntawm lub hom phiaj raws li lawv cov neeg mob coob thiab muaj cov chaw kho mob loj hauv nroog. Ib yam li ntawd, cov twj paj nruag, suav nrog ABI 7500 thiab Abbott m2000 cov cuab yeej PCR lub sijhawm tiag tiag, raug xaiv raws li cov lus pom zoo ntawm NAAT reagent manufacturers, thiab plaub PCR kuaj cov khoom siv tau raug xaiv rau txoj kev tshawb no, raws li feem ntau lub chaw soj nstuam hauv Ethiopia siv yam tsawg kawg nkaus. plaub ntawm lawv. Gene test, Abbott SARS-CoV-2 test, Sansure Biotech test, and SARS-CoV-2 BGI test ua thaum kawm).
Kev kuaj rau SARS-CoV-2 tau ua txij li 1 txog 30 Lub Kaum Ob Hlis 2020 siv 3 ml ntawm Viral Transport Medium (VTM) (Miraclean Technology, Shenzhen, Tuam Tshoj) los ntawm cov tib neeg hauv kev tshawb nrhiav COVID-19 xa mus rau EPHI. Cov qauv nasopharyngeal tau sau los ntawm cov kws sau cov qauv uas tau kawm thiab xa mus rau EPHI hauv peb lub pob. Ua ntej nucleic acid cais tawm, txhua tus qauv raug muab tus lej cim tshwj xeeb. Extraction yog ua los ntawm txhua tus qauv tam sim ntawd thaum tuaj txog siv phau ntawv thiab tsis siv neeg rho tawm txoj kev. Yog li, rau kev rho tawm tsis siv neeg ntawm Abbott m2000, 1.3 ml (xws li 0.8 ml tuag ntim thiab 0.5 ml extraction inlet ntim) ntawm cov qauv raug muab rho tawm los ntawm txhua tus qauv thiab dhau los ntawm Abbott DNA Sample Preparation System (Abbott Molecular Inc. des Plaines, IL, USA). ) Ib pawg ntawm 96 [92 cov qauv, ob qhov kev kuaj xyuas thiab ob qhov kev tswj tsis yog qauv (NTC)] tau suav nrog hauv cov txheej txheem tag nrho (retrieval thiab detection) ntawm ob lub voj voog ntawm SARS-CoV-2 (EUA) hauv lub sijhawm. mining. Ib yam li ntawd, rau phau ntawv rho tawm, siv tib cov qauv (rau kev rho tawm tsis siv neeg thiab nrhiav pom). Yog li, thoob plaws hauv cov txheej txheem, 140 µl cov qauv raug aliquoted thiab muab rho tawm siv QIAamp Viral RNA Mini Cov Khoom Siv (QIAGEN GmbH, Hilden, Lub teb chaws Yelemees) hauv batch ntawm 24 (suav nrog 20 cov qauv, ob qho kev ntsuam xyuas thiab ob NTCs) dhau cuaj puag ncig. Manually extracted eluates tau nthuav dav thiab kuaj pom siv ABI 7500 thermal cycler siv SARS-CoV-2 BGI assay, Daan Gene assay, thiab Sansure Biotech assay.
Automated cais thiab purification ntawm SARS-CoV-2 viral RNA ua raws li lub hauv paus ntsiab lus sib nqus hlaws siv Abbott DNA qauv npaj reagents. Inactivation ntawm cov qauv thiab solubilization ntawm cov kab mob yog nqa tawm siv ib tug detergent uas muaj guanidine isothiocyanate rau denature protein thiab inactivate RNase. Tom qab ntawd RNA raug cais tawm ntawm cov protein los ntawm cov theem sib cais siv silica, piv txwv li cov ntsev guanidinium thiab alkaline pH ntawm cov lysis tsis pab txhawb kev khi ntawm nucleic acids rau silica (SiO2). Cov kauj ruam yaug tshem tawm cov protein uas tseem tshuav thiab cov khib nyiab los tsim cov tshuaj ntshiab. Pob tshab RNA yog cais los ntawm silica-raws li microparticles siv lub ntsuas ntsuas magnetic teb 20,21. Ntawm qhov tod tes, kev sib cais ntawm phau ntawv thiab kev ua kom huv ntawm RNA yog ua los ntawm txoj kev tig kab siv centrifugation es tsis txhob siv cov hlau nplaum sawv ntsug thiab sib cais ntawm microparticles los ntawm eluent.
Abbott Real-Time SARS-CoV-2 Detection Test (Abbott Molecular, Inc.) tau ua raws li cov chaw tsim khoom cov lus qhia, uas tau txais EUA19,22 los ntawm WHO thiab FDA. Nyob rau hauv cov txheej txheem no, cov qauv inactivation ua ntej extraction tau ua nyob rau hauv ib da dej ntawm 56 ° C rau 30 min. Tom qab tus kab mob inactivation, nucleic acid extraction tau ua rau ntawm Abbott m2000 SP ntsuas los ntawm 0.5 ml VTM siv Abbott m2000 DNA qauv npaj system. raws li cov neeg tsim khoom. Amplification thiab kuaj pom tau ua los ntawm kev siv Abbott m2000 RT-PCR ntsuas, thiab kev tshawb nrhiav dual tau ua rau RdRp thiab N noob. ROX) thiab VIC P (cov khoom siv zas xim) rau kev tsom thiab tshawb xyuas cov kev tswj hwm sab hauv, tso cai rau kev tshawb nrhiav ib txhij ntawm ob qho khoom lag luam amplification 19 .
Txoj kev kuaj pom kev nthuav dav ntawm cov khoom siv no yog ua raws li ib-kauj ruam RT-PCR thev naus laus zis. Lub ORF1a / b thiab N noob tau raug xaiv raws li thaj chaw khaws cia los ntawm Daan Gene Technology txhawm rau txheeb xyuas lub hom phiaj kev nthuav dav hauv cheeb tsam. Cov primers tshwj xeeb thiab fluorescent probes (N gene probes labeled with FAM, ORF1a/b probes labeled with VIC) tau tsim los kuaj SARS-CoV-2 RNA hauv cov qauv. Qhov kawg eluent thiab master mixes tau npaj los ntawm kev ntxiv 5 µl ntawm eluent rau 20 µl ntawm tus tswv mix mus rau qhov kawg ntim ntawm 25 µl. Amplification thiab nrhiav tau ib txhij ntawm ABI 750024 PCR ntsuas lub sijhawm.
ORF1a/b thiab N noob tau kuaj pom siv Sansure Biotech nCoV-2019 Nucleic Acid Diagnostic Kit (fluorescent PCR detection). Npaj cov kev sojntsuam tshwj xeeb rau txhua lub hom phiaj los ntawm kev xaiv FAM channel rau thaj tsam ORF1a/b thiab ROX channel rau N gene. Rau cov khoom siv tshuaj ntsuam no, eluent thiab master mix reagents tau ntxiv raws li hauv qab no: npaj 30 µl master mix reagent thiab 20 µl eluted qauv rau kev kuaj pom / ua kom nrov. Real-time PCR ABI 750025 tau siv rau kev nthuav dav / kuaj pom.
SARS-CoV-2 BGI test yog fluorescent real-time rRT-PCR kit for the diagnosis of COVID-19. Lub hom phiaj cheeb tsam yog nyob rau hauv cheeb tsam ORF1a/b ntawm SARS-CoV-2 genome, uas yog ib txoj kev tshawb nrhiav noob caj noob ces. Tsis tas li ntawd, tib neeg kev tu vaj tse hauv tsev β-actin yog ib qho kev tswj hwm hauv lub hom phiaj. Tus tswv mix yog npaj los ntawm kev sib tov 20 µl ntawm tus tswv mix reagent thiab 10 µl ntawm cov qauv RNA rho tawm hauv lub phaj zoo26. ABI 7500 fluorescent quantitative real-time PCR ntsuas tau siv rau kev nthuav dav thiab kuaj pom. Tag nrho cov nucleic acid amplification, PCR khiav tej yam kev mob rau txhua qhov kev ntsuam xyuas, thiab kev txhais cov txiaj ntsig tau ua raws li cov chaw tsim khoom cov lus qhia (Table 3).
Hauv kev txheeb xyuas qhov sib piv no, peb tsis tau siv cov qauv siv los txiav txim siab feem pua ​​kev pom zoo (zoo, tsis zoo, thiab tag nrho) thiab lwm yam kev sib piv rau plaub qhov kev ntsuam xyuas. Txhua qhov kev sib piv tau ua tiav nrog CRS, hauv txoj kev tshawb no CRS tau teeb tsa los ntawm txoj cai "ib yam zoo" thiab cov txiaj ntsig tau txiav txim siab, tsis yog los ntawm ib qho kev xeem, peb siv tsawg kawg yog ob qhov kev xeem sib tw. Tsis tas li ntawd, nyob rau hauv cov ntaub ntawv ntawm COVID-19 kis tau tus mob, cov txiaj ntsig tsis zoo yog qhov txaus ntshai dua li cov txiaj ntsig tsis zoo. Yog li ntawd, kom hais "zoo" kom raug raws li qhov ua tau los ntawm CRS qhov tshwm sim, tsawg kawg yog ob qhov kev ntsuam xyuas yuav tsum yog qhov zoo, txhais tau hais tias tsawg kawg ib qho txiaj ntsig zoo yuav yog los ntawm EUA kev soj ntsuam. Yog li, tawm ntawm plaub qhov kev xeem, ob lossis ntau qhov kev xeem uas muab cov txiaj ntsig zoo ib yam yog suav tias yog qhov zoo lossis tsis zoo18,27.
Cov ntaub ntawv tau sau los ntawm cov ntaub ntawv rho tawm cov ntaub ntawv, cov ntaub ntawv nkag thiab tshuaj xyuas tau ua los ntawm Excel cov ntaub ntawv txheeb xyuas software thiab SPSS version 23.0 rau kev piav qhia txheeb cais. Qhov zoo, qhov tsis zoo, thiab tag nrho cov feem pua ​​​​kev pom zoo tau txheeb xyuas, thiab cov qhab nia Kappa tau siv los txiav txim siab qib kev pom zoo ntawm txhua txoj hauv kev nrog CRS. Kappa tus nqi raug txhais raws li hauv qab no: 0.01 txog 0.20 rau kev pom zoo me me, 0.21 txog 0.40 rau kev pom zoo dav dav, 0.41-0.60 rau kev pom zoo nruab nrab, 0.61-0.80 rau kev pom zoo loj thiab 0.81-0.99 rau kev pom zoo tiav 28.
Kev lees paub kev ncaj ncees tau txais los ntawm University of Addis Ababa thiab tag nrho cov txheej txheem sim rau txoj kev tshawb fawb no tau pom zoo los ntawm Ethiopian Public Health Institute's Scientific Ethics Review Board. Tus lej siv rau EPHI Ethics License yog EPHI/IRB-279-2020. Txhua txoj hauv kev tau siv raws li cov lus pom zoo thiab cov kev cai ntawm Ethiopian National Comprehensive Guidelines for the Treatment of COVID-19. Tsis tas li ntawd, sau ntawv tso cai tau txais los ntawm txhua tus neeg koom nrog kev kawm ua ntej kev koom tes hauv txoj kev tshawb fawb.
Tag nrho cov ntaub ntawv tau los yog tshuaj xyuas hauv qhov kev tshawb fawb no suav nrog hauv tsab xov xwm no. Cov ntaub ntawv txhawb nqa cov txiaj ntsig ntawm txoj kev tshawb fawb no muaj los ntawm tus kws sau ntawv raws li qhov kev thov tsim nyog.
Koom Haum Saib Xyuas Kev Noj Qab Haus Huv Thoob Ntiaj Teb. Cov lus pom zoo rau Laboratory Test Strategies for COVID-19: Interim Guidance, March 21, 2020 No. WHO/2019-nCoV/lab_testing/2020.1 (WHO, 2020).
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Ethiopian Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv, Tsoom Fwv Tebchaws Ministry of Health. Ib ntus National Strategy and Guide for Laboratory Diagnosis of COVID-19. https://ephi.gov.et/images/novel_coronavirus/EPHI_PHEOC_COVID-19_Laboratory_Diagnosis_Eng.pdf ( nkag mus rau 12 Lub Yim Hli 2020) (EPHI, 2020).
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