Umntu EML4-ALK Fusion Gene Mutation

Inkcazelo emfutshane:

Le khithi isetyenziselwa ukubona ngokusemgangathweni iintlobo ezili-12 zoguqulo lwe-EML4-ALK yofuzo lwemfuza kwiisampulu zezigulane zomhlaza wemiphunga weseli yabantu ezingancinci kwi-vitro.Iziphumo zovavanyo zezereferensi yeklinikhi kuphela kwaye akufanele zisetyenziswe njengesiseko sodwa sonyango lwezigulane.Oogqirha kufuneka benze izigwebo ezibanzi kwiziphumo zovavanyo ngokusekelwe kwizinto ezifana nemeko yesigulane, izibonakaliso zamachiza, impendulo yonyango, kunye nezinye izikhombisi zovavanyo lwebhubhoratri.


Iinkcukacha zeMveliso

Iithegi zeMveliso

Igama lemveliso

I-HWTS-TM006-Human EML4-ALK Fusion Gene Mutation Detection Kit(Fluorescence PCR)

Isatifikethi

TFDA

I-Epidemiology

Le khithi isetyenziselwa ukubona ngokusemgangathweni iintlobo ezili-12 zokuguqula i-EML4-ALK yofuzo lwemfuza kwiisampulu zabantu abangengobancinci abanomhlaza wemiphunga kwi-vitro.Iziphumo zovavanyo zezereferensi yeklinikhi kuphela kwaye akufanele zisetyenziswe njengesiseko sodwa sonyango lwezigulane.Oogqirha kufuneka benze izigwebo ezibanzi kwiziphumo zovavanyo ngokusekelwe kwizinto ezifana nemeko yesigulane, izibonakaliso zamachiza, impendulo yonyango, kunye nezinye izikhombisi zovavanyo lwebhubhoratri.Umhlaza wemiphunga lelona thumba liyingozi lixhaphakileyo kwihlabathi liphela, kwaye i-80% ~ 85% yamatyala ngumhlaza wemiphunga weseli ongeyonxalenye encinci (NSCLC).I-Gene fusion ye-echinoderm microtubule-enxulumene neprotein-efana ne-4 (EML4) kunye ne-anaplastic lymphoma kinase (ALK) yithagethi yenoveli kwi-NSCLC, EML4 kunye ne-ALK ngokulandelelanayo ibekwe emntwini i-P21 kunye ne-P23 bands kwi-chromosome 2 kwaye zahlulwe malunga ne-12.7 izigidi izibini isiseko.Ubuncinci i-20 ye-fusion ye-fusion ifunyenwe, phakathi kwayo i-12 fusion mutants kwiTheyibhile 1 ixhaphakile, apho i-mutant 1 (E13; A20) yeyona ixhaphakileyo, ilandelwa yi-mutant 3a kunye ne-3b (E6; A20), ibala malunga I-33% kunye ne-29% yezigulane ezine-EML4-ALK fusion gene NSCLC, ngokulandelanayo.I-ALK inhibitors emelwe yi-Crizotinib ngamachiza amancinci ajoliswe kuyo aphuhliswe ukuguqulwa kwe-ALK gene fusion.Ngokuthintela umsebenzi wengingqi ye-ALK tyrosine kinase, ivalela iindlela zayo zokubonisa ezingaqhelekanga ezisezantsi, ngaloo ndlela inqanda ukukhula kweeseli zethumba, ukufezekisa unyango olujoliswe kuyo kwiithumba.Izifundo zeklinikhi zibonise ukuba i-Crizotinib inezinga elisebenzayo elingaphezulu kwe-61% kwizigulane ezine-EML4-ALK yokuguqulwa kwe-fusion, ngelixa iphantse ingabi nampembelelo kwizigulane zohlobo lwasendle.Ngoko ke, ukufunyaniswa kwe-EML4-ALK ukuguqulwa kwe-fusion yisiseko kunye nesiseko sokukhokela ukusetyenziswa kweziyobisi zeCrizotinib.

Umjelo

FAM Isithinteli sokuphendula 1, 2
VIC(HEX) Isithinteli sokusabela 2

IiParameters zobuGcisa

Ugcino

≤-18℃

Beka ubomi kwishelufa

Iinyanga ezili-9

Uhlobo loMfanekiso

Iparafini efakwe kwizicubu ze-pathological okanye iisampuli zecandelo

CV

<5.0%

Ct

≤38

LoD

Le khithi inokubona utshintsho lwe-fusion olusezantsi njengeekopi ezingama-20.

Izixhobo Ezisebenzayo:

Iinkqubo ze-Biosystems ezisetyenzisiweyo 7500 Iinkqubo zePCR zeXesha langempela

Iinkqubo ze-Biosystems eziSetyenzisiweyo 7500 Iinkqubo zePCR ezikhawulezayo

I-SLAN ®-96P Iinkqubo ze-PCR zeXesha langempela

IQuantStudio™ 5 Iinkqubo zePCR zeXesha langempela

Inkqubo yePCR yeLightCycler®480 yeXesha langempela

I-LineGene 9600 Plus Real-Time PCR Detection System

MA-6000 Real-Time Quantitative Thermal Cycler

I-BioRad CFX96 Inkqubo yePCR yexesha lokwenyani

BioRad CFX Opus 96 Real-Time PCR System

Ukuhamba komsebenzi

Isixhobo sokukhutshwa esicetyiswayo: RNeasy FFPE Kit (73504) yi-QIAGEN, iParaffin-embedded Tissue Sections Total RNA Extraction Kit(DP439) by Tiangen Biotech(Beijing) Co.,Ltd.


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