Intwaro Nshya yo Gusuzuma Igituntu no Gutahura Ubudahangarwa bw'Imiti: Uburyo bushya bwo Gukurikirana Ibisekuruza (tNGS) Buhujwe n'Ikoranabuhanga ryo Kwiga Igituntu mu Gusuzuma Ubudahangarwa bw'Igituntu
Raporo y'ibitabo: CCa: icyitegererezo cyo gusuzuma gishingiye kuri tNGS na machine learning, gikwiriye abantu bafite igituntu gike cya bagiteri na meningitis y'ibibyimba.
Umutwe w'inyandiko: Gukurikirana indwara y'igituntu gishya hamwe n'uburyo bwo kwiga imashini: ingamba zo gusuzuma indwara z'imiyoboro y'ibihaha idahagije na meningite y'imiyoboro y'ibitunguru.
Igihe cyagenwe: 《Clinica Chimica Acta》
NIBA: 6.5
Itariki yo gusohorwa: Mutarama 2024
Bihujwe na Kaminuza y’Ubushinwa Ishuri Rikuru ry’Ubumenyi n’Ibitaro bya Beijing Chest bya Kaminuza y’Ubuvuzi ya Capital, Macro & Micro-Test byashyizeho uburyo bwo gusuzuma igituntu bushingiye ku ikoranabuhanga rishya ryo gusesengura (tNGS) n’uburyo bwo kwigira ku mashini, byatanze ubushobozi bwo kumenya igituntu cyane hamwe na bagiteri nke na meningite y’igituntu, bitanga uburyo bushya bwo gusuzuma indwara y’igituntu mu gusuzuma ubwoko bubiri bw’igituntu, kandi byafashije mu gusuzuma neza igituntu, kumenya imiti idakira no kuvura igituntu. Muri icyo gihe, byagaragaye ko plasma cfDNA y’umurwayi ishobora gukoreshwa nk’ubwoko bukwiriye bwo gupima igituntu mu gusuzuma TBM.
Muri ubu bushakashatsi, ingero 227 z'amaraso mu maraso n'ibice by'amazi yo mu bwonko byakoreshejwe kugira ngo hamenyekane amatsinda abiri y'abaganga, aho ingero z'amatsinda yo gusuzuma indwara ya laboratwari zakoreshejwe kugira ngo hamenyekane icyitegererezo cyo gusuzuma igituntu mu mashini, naho ingero z'amatsinda yo gusuzuma indwara zakoreshejwe kugira ngo hamenyekane icyitegererezo cy'indwara cyashyizweho. Ingero zose zabanje kwibandwaho n'icyiciro cyihariye cyo gufata Mycobacterium tuberculosis. Hanyuma, hashingiwe ku makuru ajyanye n'ikurikiranwa rya TB-tNGS, icyitegererezo cy'igiti cy'imyanzuro gikoreshwa mu gukora igenzura ry'inshuro 5 ku matsinda y'amahugurwa n'igenzura ry'umurongo w'isuzuma rya laboratwari, hanyuma haboneka ingero z'isuzuma ry'ibice by'amaraso mu maraso n'ibice by'amazi yo mu bwonko. Ingano yabonetse ishyirwa mu byiciro bibiri by'ibizamini byo gusuzuma indwara kugira ngo hamenyekane, kandi imikorere y'umunyeshuri mu gusuzuma indwara ipimwa hakoreshejwe umurongo wa ROC. Amaherezo, icyitegererezo cyo gusuzuma igituntu cyabonetse.
Ishusho ya 1 y'igishushanyo mbonera cy'ubushakashatsi
Ibisubizo: Dukurikije ibipimo byihariye bya ADN ya CSF (AUC = 0.974) n'icyitegererezo cya cfDNA muri plasma (AUC = 0.908) byagaragajwe muri ubu bushakashatsi, mu bipimo 227, ubushobozi bwo kumenya CSF bwari 97.01%, umwihariko wari 95.65%, naho ubushobozi bwo kumenya no kumenya umwihariko wa ADN ya plasma bwari 82.61% na 86.36%. Mu isesengura ry'ibipimo 44 bya ADN ya plasma na ADN y'amazi yo mu bwonko bivuye ku barwayi ba TBM, ingamba zo gusuzuma ubu bushakashatsi zifite uburinganire bungana na 90.91% (40/44) muri ADN ya cfDNA muri plasma na ADN y'amazi yo mu bwonko, kandi ubushobozi bwo kumenya ni 95.45% (42/44). Ku bana barwaye igituntu cy'ibihaha, ingamba zo gusuzuma ubu bushakashatsi zirushaho gusobanukirwa neza ingero za plasma kuruta ibisubizo bya Xpert byo kumenya ingero z'umutobe w'igifu bivuye ku barwayi bamwe (28.57% VS 15.38%).
Ishusho ya 2 Isesengura ry'imikorere y'icyitegererezo cyo gusuzuma igituntu ku bipimo by'abaturage
Igishushanyo cya 3 Ibisubizo byo gusuzuma ingero zihujwe
Umwanzuro: Muri ubu bushakashatsi hashyizweho uburyo bwo gusuzuma igituntu bushobora kugaragara cyane, bushobora gutanga igikoresho cyo gusuzuma gifite ubushobozi bwo kumenya abarwayi barwaye igituntu cya oligobacillary (cyangwa imiterere mibi). Gupima igituntu gikabije hashingiwe kuri plasma cfDNA bishobora kuba ubwoko bwiza bwo gusuzuma igituntu gifatika na meningitis y’ibibyimba (ibipimo bya plasma biroroshye gukusanya kurusha amazi yo mu bwonko ku barwayi bakekwaho igituntu cyo mu bwonko).
Umurongo w'umwimerere: https://www.sciencedirect.com/science/article/pii/s0009898123004990? via%3Dihub
Incamake y'ibicuruzwa byo gupima igituntu mu buryo bwa Macro & Micro-Test
Bitewe n’imiterere y’ingero zigoye z’abarwayi ba igituntu n’ibyo bakeneye bitandukanye, Macro & Micro-Test itanga seti yuzuye y’ibisubizo bya NGS byo gukuramo amazi mu mashanyarazi, kubaka no gukurikirana isomero rya Qualcomm, no gusesengura amakuru. Ibi bikoresho bikubiyemo gusuzuma vuba abarwayi ba igituntu, kumenya igituntu kidakira imiti, kwandika igituntu cya mycobacterium na NTM, gusuzuma igituntu kidaterwa na bagiteri n’abantu barwaye igituntu, n’ibindi.
Ibikoresho byo gupima igituntu n'udukoko twa mycobacteria:
| Umubare w'Igikoresho | izina ry'igicuruzwa | ibikubiye mu igerageza ry'ibicuruzwa | ubwoko bw'icyitegererezo | icyitegererezo gikurikizwa |
| HWTS-3012 | Urugero rw'umukozi urekura | Yakoreshejwe mu kuvura ibisebe byatewe n'amazi, yabonye inomero ya mbere, Sutong Machinery Equipment 20230047. | inkorora | |
| HWTS-NGS-P00021 | Kit yo gupima ingano ya Qualcomm ku gituntu cy’igikatu (uburyo bwo gufata ubushakashatsi) | Gupima indwara y’igituntu cy’ibihaha idakwirakwira (biopsy y’amazi) ku ndwara y’igituntu cy’ibihaha n’uturemangingo two mu bwonko; Ingero z’abantu bakekwaho kwandura igituntu cy’ibihaha cyangwa mycobacteria idakwirakwira mu gituntu zasesenguwe hakoreshejwe uburyo bwimbitse bwo gusuzuma amakuru, ndetse n’amakuru yo kumenya niba mycobacteria ikwirakwira mu gituntu cyangwa idakwirakwira mu gituntu yatanzwe ndetse n’amakuru y’ingenzi ajyanye no kwirinda imiti ya mycobacteria. | Amaraso yo ku nkengero z'umugongo, amazi yo koza alveolar, hydrothorax na ascites, icyitegererezo cyo gutobora, amazi yo mu bwonko. | Itsinda rya kabiri |
| HWTS-NGS-T001 | Mycobacterium type and drug detection kit (uburyo bwo gutondekanya uburyo bwo kongera ingufu mu mikorere) | Ikizamini cyo kwandika Mycobacterium, harimo MTBC na 187 NTM；Gusuzuma indwara ya Mycobacterium tuberculosis irwanya imiti bikubiyemo imiti 13 n'ahantu 16 h'ingenzi hahinduka ingirabuzimafatizo zirwanya imiti. | Amashoka, amazi yo koza alveolar, hydrothorax na ascites, icyitegererezo cyo gutobora, amazi yo mu bwonko. | Urubuga rwa kabiri/rwa gatatu rw'ibikoresho bibiri |
Ibintu by'ingenzi: HWTS-NGS-T001 Mycobacterium typing and drug detection detection (uburyo bwo kongera imbaraga mu buryo bwinshi)
Intangiriro y'ibicuruzwa
Uyu muti ushingiye ku miti y’ingenzi yo ku rwego rwa mbere n’urwa kabiri ivugwa mu mabwiriza ya OMS yo kuvura igituntu, macrolides na aminoglycosides bikunze gukoreshwa mu mabwiriza ya NTM yo kuvura, kandi ahantu hadakoreshejwe imiti hakubiyemo itsinda rimwe ry’ahantu hafitanye isano no kudakoresha imiti muri kataloge ya WHO Mycobacterium tuberculosis complex mutation, ndetse n’ahandi havugwamo genes na mutations nk’uko iperereza n’imibare by’ibitabo byanditse mu nyandiko zanditse mu gihugu no mu mahanga.
Gutahura ubwoko bwa NTM bishingira ku bwoko bwa NTM bukubiye mu mabwiriza ya NTM yasohotse mu kinyamakuru cy’Abashinwa cy’indwara z’igifu n’ubuhumekero ndetse n’impuguke z’inzobere. Udukoresho twakozwe mu kwandika dushobora kongera, gutunganya no gusobanura ubwoko bwa NTM burenga 190.
Binyuze mu ikoranabuhanga ryo kongera ubushobozi bwa PCR mu gutera indwara, imiterere y’uturemangingo tw’uturemangingo n’uturemangingo twa Mycobacterium twongerewe ubushobozi bwo kongera ubushobozi bwa PCR, kandi habonetse uburyo bwo guhuza amplicon n’uturemangingo tw’uturemangingo tugomba kuboneka. Ibicuruzwa byongerewe ubushobozi bishobora kubakwa mu bubiko bw’ibisekuruza by’icyiciro cya kabiri cyangwa icya gatatu, kandi urubuga rwose rwo gukuramo uburyo bw’icyiciro cya kabiri n’icya gatatu rushobora gukorerwaho ubushakashatsi bwimbitse kugira ngo haboneke amakuru y’uruhererekane rw’uturemangingo tw’uturemangingo tw’uturemangingo. Mu kugereranya n’impinduka zizwi ziri muri database yubatswemo (harimo na kataloge ya WHO ya Mycobacterium tuberculosis complex mutation hamwe n’isano ifitanye n’impinduka ziterwa n’imiti), impinduka zijyanye no kudakira imiti cyangwa kwihanganira imiti irwanya igituntu zaragaragaye. Hamwe n’uburyo bwo kuvura indwara ya Macro & Micro-Test bwifunguye, ikibazo cyo kudakora neza kwa aside nucleic muscles y’ibice by’amatako byo mu buvuzi (inshuro icumi kuruta uburyo gakondo) cyakemutse, kugira ngo uburyo bwo kumenya uburyo imiti ishobora gukurikizwa mu buryo butaziguye ku bipimo by’amatako yo mu buvuzi.
Uruhererekane rwo kumenya ibicuruzwa
34jeni zifitanye isano no kudakira imiti za18imiti irwanya igituntu n'imiti6Imiti ya NTM yabonetse, ikubiyemo297ahantu hadakoreshwa imiti; Ubwoko icumi bwa Mycobacterium tuberculosis n'ibindi birenga190ubwoko bwa NTM bwarabonetse.
Imbonerahamwe ya 1: Amakuru ku biyobyabwenge 18+6 +190+NTM
Akamaro k'ibicuruzwa
Uburyo bwo kwihutisha ubuvuzi: ingero z'amatembabuzi zishobora kuboneka mu buryo butaziguye hakoreshejwe umuti wica amazi udafite ubwiyongere bw'amatembabuzi.
Igikorwa cyo kugerageza cyoroshye: icyiciro cya mbere cy'ibikorwa byo kongera ingufu ni cyoroshye, kandi kubaka isomero birangira mu masaha 3, ibyo bikanoza imikorere myiza.
Kwandika no kurwanya imiti mu buryo bwuzuye: gusesengura ahantu hatandukanye ha MTB na NTM hagaragara ibibazo byo kwandika no kurwanya imiti, ari na byo bintu by'ingenzi bihangayikishije ubuvuzi, kwandika no kumenya neza uburyo imiti ikoreshwa, gushyigikira porogaramu zigenga zo gusesengura, no gukora raporo z'isesengura ukoresheje akantu kamwe gusa.
Guhuza: guhuza ibicuruzwa, guhuza na platform zisanzwe za ILM na MGI/ONT.
Ibisobanuro by'ibicuruzwa
| Kode y'igicuruzwa | izina ry'igicuruzwa | Urubuga rwo gutahura | ibipimo |
| HWTS-NGS-T001 | Mycobacterium type and drug detection kit (uburyo bwo kongera imbaraga mu buryo bwinshi) | ONT 、 Illumina 、 MGI 、 Salus pro | 16/96rxn |
Igihe cyo kohereza: Mutarama-23-2024