SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02786381

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Idylla Respiratory (IFV-RSV) Panel Clinical Testing and Sample Collection Protocol in Support of 510(k) Premarket Submission

This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.

NCT02786381 Respiratory Tract Infections Influenza, Human Respiratory Syncytial Virus Infections
MeSH: Infection Communicable Diseases Virus Diseases Respiratory Tract Infections Respiratory Syncytial Virus Infections Influenza, Human
HPO: Respiratory tract infection


Primary Outcomes

Description: Product Performance will be assessed based on samples collected in 2015/2016 season (average of 6 months) and archived samples.

Measure: Product performance as measured by positive and negative agreement to a predicate

Time: Specimen collected during the IFV-RSV season 2015/2016 will be tested within 1 day of enrollment. The Product Performance will be assessed at study completion, an average of 6 months.

Time Perspective: Cross-Sectional


There is one SNP

SNPs


1 H275Y

The IFV-RSV Panel is an in vitro PCR-based molecular diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A (including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal swabs (NP) in viral transport media (VTM) in adults, adolescents, and children. --- H275Y ---



HPO Nodes


HPO:
Respiratory tract infection
Genes 441
NHLRC1 TPM2 TPM3 PIGN TPP2 SCN11A SLC29A3 ERCC2 ERCC3 CFAP300 RNF168 ERF MANBA HLA-B AICDA HLA-DPA1 PYROXD1 ORC6 HLA-DPB1 USP9X SLC35C1 CCDC114 CTSC TRAIP ACP5 CFTR NCF1 ACTA1 TRPS1 PEPD BLNK SLC5A7 CCNO CLEC7A TCIRG1 PEX13 MCM4 CHAT IKZF1 TSC1 TSC2 LRRC6 TMEM173 ARID1A ADA COLQ TRIP11 IL17F LYST CHRM3 MECP2 TRIP4 ZNHIT3 MYSM1 NME8 RYR1 PGM3 TBC1D24 RNU4ATAC TYK2 CRELD1 ARID1B SAMD9L PANK2 ICOS SFTPA2 MBTPS2 MGP CLCN7 ZMYND10 CIITA FCGR3A PIK3CD AGA PIK3R1 EDARADD RAB3GAP2 NPAP1 SNX10 SCN9A SCN10A SCNN1A SCNN1B SCNN1G GTF2H5 AK2 UMPS UNG NOP10 IL17RA PLCG2 PWAR1 PLEC PLG PLOD1 PLP1 KDM6A NIPBL CCDC151 RSPH9 ALG12 COG4 ALOX12B ALPL PMM2 SLC25A24 FLI1 COL6A1 COL6A2 FLNA COL6A3 EXOSC9 CLCA4 FBLN5 COL11A2 MAGEL2 FMO3 CCDC22 COL13A1 LAMTOR2 WAS CCDC103 WIPF1 OFD1 ADAMTS3 CLIP2 SFTPC CTC1 NSD2 SGCG NELFA POLA1 SGSH POLE GNPTAB SLC35A1 IRF8 IKBKG ELP1 BIRC3 XIAP LIPN CHD7 GTF2IRD1 IDUA CFI FCN3 NHP2 CR2 SP110 CREBBP CFAP298 ZAP70 CRKL EPG5 DNAH1 MSN SDR9C7 WDR19 IFNGR1 DNAI1 TNFSF11 ARSB CSF2RA CSF2RB G6PC3 IGH MTHFD1 ASAH1 SLC18A3 SLC25A1 RFXANK IGHM IL21R SETBP1 DLL3 MPLKIP SMARCA4 SMARCB1 SMARCC2 CYP4F22 SMARCD2 PRKCD SMARCE1 FOXP1 SMN1 CARD11 SMPD1 MESP2 CTLA4 FUCA1 IGLL1 PRKDC ATM NGLY1 SNAP25 MAPK1 TBC1D23 IKBKB CCDC65 IL2RA IL2RG SNRPN HYDIN GAA AFF4 IL7R MASP2 DNAH11 CYBA PRPS1 CYBB MKRN3 SNORD115-1 TRAF3IP2 SOX11 TCTN3 STK36 MYH3 SPAG1 MYL2 SAMD9 PRTN3 GALNS PSAP RIPK1 KIF1A MYO5A TNFSF12 RTEL1 MYO9A ABCA12 JAGN1 MCIDAS NADK2 INPPL1 SDCCAG8 CYBC1 B2M RNF113A KIAA0586 VPS33A INSR NAGLU GAS8 MAP3K20 GATA2 GATA4 GATA6 CD55 GBA IPW PWRN1 SRP54 NBN DRC1 SIK1 PTPN22 NCF2 NCF4 SLC46A1 TTC25 NDN TNFRSF11A DNAL1 ITGA3 ITGA7 BCR GFI1 ZBTB24 SNORD116-1 STAT1 CFB STAT3 SLC52A3 BLM DNAJB13 JAK3 DNAAF5 IFIH1 DNAAF3 MALT1 TIMM8A STX1A RNF125 GLB1 ALMS1 SULT2B1 RSPH1 TINF2 TECPR2 WASHC5 NFE2L2 CXCR4 NFIX GLI3 KCNJ6 NFKB1 BTK NFKB2 NFKBIA NECTIN1 IL21 VAMP1 VPS13A LRRC56 DKC1 KIAA0556 BCL10 TAF1 HERC2 DNAH5 TAP1 TAP2 TAPBP AP3D1 GNS CFAP410 NOTCH2 NOTCH3 TBCE PNP CCDC40 DNMT3B SPINK5 FOXP3 TBX6 KRAS SLC12A6 CACNA1C RAG1 RAG2 NIPAL4 FAT4 TCF3 EPM2A CARMIL2 NRAS RSPH4A WDR34 USB1 DSG1 DOCK8 SLC26A2 DNAAF4 ROR2 DDR2 HGSNAT LAMA2 BAZ1B CASP8 LAMB2 OAS1 IL17RC RELB OCRL SYT2 DPF2 ARMC4 RUNX2 LCK RFC2 WRAP53 NSMCE3 TERC ECM1 CHAMP1 SELENON TERT NXN RFX5 RFXAP GMNN LEP CCDC39 LEPR LETM1 NR2F2 POLR3A MKRN3-AS1 TFRC TGFB1 DNAAF2 UNC119 SLC25A22 RMRP TGM1 LIG4 CORO1A LIMK1 GTF2E2 CD3D CD3E RSPH3 CD3G KMT2D GTF2I CD8A CD19 MS4A1 EGFR DCLRE1C CDCA7 ZNF341 NKX2-1 TK2 GUSB CCBE1 ARID2 IER3IP1 HPS6 DNAI2 IRAK4 TNFRSF13C EHMT1 LRRC8A ELANE TNFRSF13B CD79A CD79B PIH1D3 CD81 ALOXE3 PARN ELN LTBP3 RPGR LRBA DCTN4 TNFRSF1A DNAAF1 KAT6B SH2D1A CSPP1 AGRN HACD1 TBL2 EP300 ATP6V0A2 PCNT HELLS