感染性疾病嚴重威脅人類健康 一
病原微生物快速鑑定亟待解決
Infectious diseases seriously threaten human health - rapid identification of pathogenic microorganisms needs to be solved
近年來，感染性疾病(infectious disease)已成為一種嚴重威脅人類健康的疾病。造成人類感染的病原微生物種類繁多，臨床亟待一種經濟、高效的檢測手段，快速確認感染病原體並檢測抗藥基因，對於感染患者，尤其是病危患者，是後續對症治療的關鍵。
感染性疾病形勢
日益嚴峻
- 至2018年，下呼吸道感染已上升至死亡原因第三位(319萬人死亡，占所有死亡人數的5.6%)
- 據統計，感染性疾病占所有疾病的50%以上
- 有研究顯示，預計感染性疾病引起的死亡人數在2050年將達到1000萬
臨床病原感染
情況複雜
- 不明原因發熱
- 臨床症狀不典型
- 多種病原體合併感染
- 新發或罕見病原體
- 移植等高危險病人大範圍感染
傳統培養鑑定
缺點明顯
- 檢出陽性率低（＜30%），難以明確找出病原
- 週期長（最長能達21天），延誤治療，尤其是危重病患者
- 只適合少數病原，覆蓋度極低
- 依賴臨床醫師做先驗判斷
用藥難精確
易延誤病情
- 用藥依賴臨床經驗
- 病原複雜，抗藥性率高
高通量定序一病原微生物檢測的最優解答
高通量定序, 通過病原微生物核酸物質序列檢測, 可實現病原快速鑑定以及抗藥基因檢測。目前高通量定序已進入病原鑑定臨床實踐。
AccuGen® 臨床常見病原微生物檢測 — 快速鑑定病原微生物及抗藥基因
AccuGen® 臨床常見病原微生物檢測採用康健自主研發的多重PCR+NGS專利技術，對臨床常見的病原微生物進行高通量定序，通過生物資訊學方法將定序數據與病原微生物專用資料庫進行比對，獲得疑似致病微生物種屬以及相關抗藥資訊，為感染患者提供快速精準診斷依據，指導藥物的合理應用。
| 產品名稱 | 檢測範圍 | 臨床意義 |
|---|---|---|
| AccuGen® 特定感染病原基因檢測 | 30種常見致病微生物及3種抗藥性 | 常見感染病原微生物鑑定 |
| AccuGen® 330感染病原基因檢測 | 330種常見致病微生物及抗藥基因 | 泛感染病原微生物鑑定及抗藥檢測 |
AccuGen® 系列包含150種抗藥基因檢測，輔助精準用藥
| 產品名稱 | 檢測範圍 |
|---|---|
| 糖肽類抗生素 | vanA,vanB,vanD |
| 氟喹諾酮類抗生素 | patA,patB,pmrA,QnrA1,QnrB4,qacA,lsaE |
| 氟喹諾酮類抗生素 | ANT(2'')-Ia,armA,AAC(2')-Ib,AAC(6')-Ib,aadA3,APH(3'')-Ib,APH(6)-Id,AAC(2'),ANT(4'),APH(3')-Ia,AAC(3),AAC(6') |
| 大環內酯類抗生素 | mphB,EreA,EreB,macA,mefE,mel,mtrC,mtrE |
| 氯黴素類抗生素 | catB3,Paer_catB6,catB8,cmlA5,floR,CAT |
| 青黴素類抗生素 | cNDM-1,mecA,mtrD,TEM-12,mecC,OXA-1,OXA-2,OXA-7,OXA-9,OXA-23,OXA-66,OXA-69,OXA-82,OXA-181,OXA-198,CMY-2,KPC-2 |
| 鏈黴素類抗生素 | ErmC,msrA,ErmA,ErmB,mel |
| 四環素類抗生素 | tet(A),tet(B),tet(C),tet(D),tet(E),tet(K), tet(L),tet(M),tet(O),tet(Q),tet(S),tet(T),tet(W), TolC,adeB,Ecol_mdfA,tetR,oqxA,oqxB,rpsJ |
*僅展示部分抗藥基因
AccuGen® 系列優勢
AccuGen® 臨床常見病原微生物檢測通過標靶富集樣本中極微量的病原微生物核酸，結合高通量定序和生物資訊分析，高精度快速鑑定細菌、真菌、病毒和寄生蟲等多種病原微生物。同時，可對病原微生物的抗藥基因進行分析，實現抗藥預判，輔助臨床精準用藥。
| 傳統病原體檢驗-培養 | mNGS檢測 | 康健微準源® AccuGen®tNGS檢測 |
|---|---|---|
| 檢出率低 | 易受人類基因組及背景菌干擾 | 靈敏度較高 不受人類基因組及背景菌的影響 |
| 週期長：3-21天 | 24-48小時出報告 | 最快24小時出報告 |
| 少數特定病原 | 全覆蓋無限多種 | 覆蓋常見99%以上病原 大幅強化RNA病毒原體檢測 上百種種耐藥基因檢測 |
| 需先驗判斷 | 無需先驗性判斷 | 基本不需先驗性判斷 |
| 金標準 | 無限制 | 需求爆發 |
| 便宜 | 定序量及價格高 | 性價比高 擁有更低的檢測成本及耗時 |
經濟
多重PCR+NGS相比宏基因組定序成本優勢明顯，綜合性價比高。
精準
通過多重PCR富集，可精準檢測高宿主背景下低拷貝的病原體。
全面
對各類疑似感染樣本中的臨床常見病原體進行全面檢測。
專業
完善的病原微生物資料庫和專業醫學團隊出具報告。
快捷
嚴謹規範的實驗流程，最快24小時完成檢測並出具報告。
AccuGen® 產品應用
適用範圍
兒童感染性疾病
呼吸系統感染
關節感染
免疫抑制人群不明
中樞系統神經感染
移植術後感染
不明原因發熱
公共突發傳染病
血流感染
AccuGen® 送樣要求
AccuGen® 特定感染病原基因檢測
| 樣本類型 | 最低送樣量 | 採檢容器 | 運輸條件 |
|---|---|---|---|
| 血液 | ≥3ml | EDTA採血管 | 冷藏運送，７天內送達 |
| 支氣管沖洗液 | ≥2ml | 無菌螺紋管/離心管 | 冷藏運送，７天內送達 |
| 肺泡灌洗液 | ≥2ml | 無菌螺紋管/離心管 | 冷藏運送，７天內送達 |
| 痰液 | ≥2ml | 無菌螺紋管/離心管 | 冷藏運送，７天內送達 |
AccuGen® 330感染病原基因檢測
| 樣本類型 | 最低送樣量 | 採檢容器 | 運輸條件 |
|---|---|---|---|
| 血液 | ≥2ml | cfDNA採血管 | 常溫運輸 |
| 骨髓 | ≥2ml | cfDNA採血管 | 常溫運輸 |
| 病理切片 | ≥5片 | 切片盒 | 常溫運輸 |
| 尿液、腦脊液、胸腹水、關節積液、膿腫抽液、膽汁 | ≥2ml | 無菌螺紋管/離心管 | 冷藏運送，７天內送達 |
| 其他穿刺液 | ≥1ml | 無菌螺紋管/離心管 | 冷藏運送，７天內送達 |
| 組織 | ≥3mm³ | 無菌螺紋管/離心管 | 冷藏運送，７天內送達 |
| 房水 | ≥0.1ml | 無菌螺紋管/離心管 | 冷藏運送，７天內送達 |
| 玻璃體 | ≥0.5ml | 無菌螺紋管/離心管 | 冷藏運送，７天內送達 |
| 鼻咽拭子、傷口滲出液 | ≥2拭子 | 拭子保存管 | 冷藏運送，７天內送達 |
AccuGen® 檢測流程
諮詢與知情同意
樣本採集
多重PCR及建庫
高通量定序
資料分析
報告解讀
臨床常見病原微生物清單 (部分)
細菌
Acinetobacter baumannii, Acinetobacter calcoaceticus, Acinetobacter johnsonii, Acinetobacter lwoffii, Acinetobacter radioresistens, Actinomyces israelii, Aeromonas caviae, Aeromonas hydrophila, Aggregatibacter actinomycetemcomitans, Alcaligenes faecalis, Aliarcobacter butzleri, Arcanobacterium haemolyticum, Bacillus anthracis, Bacillus cereus, Bacillus pumilus, Bacillus thuringiensis, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bifidobacterium animalis, Bifidobacterium breve, Bifidobacterium dentium, Bifidobacterium longum, Bordetella bronchiseptica, Bordetella hinzii, Bordetella holmesii, Bordetella parapertussis, Bordetella pertussis, Brucella intermedia, Burkholderia cenocepacia, Burkholderia cepacia, Burkholderia mallei, Burkholderia pseudomallei, Campylobacter coli, Campylobacter concisus, Campylobacter fetus, Campylobacter jejuni, Campylobacter upsaliensis, Capnocytophaga gingivalis, Capnocytophaga granulosa, Capnocytophaga haemolytica, Capnocytophaga ochracea, Capnocytophaga sputigena, Citrobacter freundii, Clostridioides difficile, Clostridium butyricum, Clostridium perfringens, Clostridium septicum, Clostridium tetani, Corynebacterium accolens, Corynebacterium afermentans, Corynebacterium diphtheriae, Corynebacterium jeikeium, Corynebacterium kutscheri, Corynebacterium pseudotuberculosis, Corynebacterium silvaticum, Corynebacterium striatum, Corynebacterium ulcerans, Coxiella burnetii, Cutibacterium acnes, Dolosigranulum pigrum, Elizabethkingia anophelis, Elizabethkingia meningoseptica, Enterobacter asburiae, Enterobacter cloacae subsp. Cloacae, Enterobacter hormaechei, Enterococcus avium, Enterococcus casseliflavus, Enterococcus faecalis, Enterococcus faecium, Erysipelothrix rhusiopathiae, Escherichia coli, Fusobacterium necrophorum, Fusobacterium nucleatum, Fusobacterium periodonticum, Gardnerella vaginalis, Haemophilus influenzae, Haemophilus parainfluenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Lactobacillus gasseri, Lactococcus garvieae, Legionella pneumophila, Leifsonia aquatica, Listeria monocytogenes, Micrococcus luteus, Moraxella catarrhalis, Morganella morganii, Mycobacterium avium subsp. paratuberculosis MAP4, Mycobacterium canettii, Mycobacterium colombiense, Mycobacterium gordonae, Mycobacterium haemophilum, Mycobacterium intracellulare, Mycobacterium kansasii, Mycobacterium leprae, Mycobacterium tuberculosis, Mycobacteroides abscessus, Mycobacteroides abscessus subsp. massiliense, Mycolicibacterium fortuitum, Mycolicibacterium iranicum, Neisseria flavescens, Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria subflava, Nocardia abscessus, Nocardia farcinica, Nocardia pneumoniae, Nocardia veterana, Nocardiopsis dassonvillei, Orientia tsutsugamushi, Paenibacillus mucilaginosus, Parvimonas micra, Pasteurella multocida, Phocaeicola vulgatus, Plesiomonas shigelloides, Porphyromonas gingivalis, Prevotella bivia, Prevotella buccae, Prevotella buccalis, Prevotella denticola, Prevotella enoeca, Prevotella intermedia, Prevotella loescheii, Prevotella melaninogenica, Proteus mirabilis, Proteus vulgaris, Providencia alcalifaciens, Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas mosselii, Pseudomonas putida, Ralstonia solanacearum, Salmonella bongori, Salmonella enterica, Salmonella enterica subsp. enterica serovar Weltevreden, Schaalia odontolytica, Serratia marcescens, Shewanella putrefaciens, Shigella dysenteriae, Shigella flexneri, Staphylococcus aureus subsp. aureus MW2, Staphylococcus capitis subsp. Capitis, Staphylococcus epidermidis, Staphylococcus equorum, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus lugdunensis, Stenotrophomonas maltophilia, Streptobacillus moniliformis, Streptococcus agalactiae, Streptococcus anginosus, Streptococcus constellatus, Streptococcus dysgalactiae, Streptococcus gallolyticus, Streptococcus gordonii, Streptococcus intermedius, Streptococcus milleri, Streptococcus mitis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus salivarius, Streptococcus sanguinis, Streptococcus suis, Stutzerimonas stutzeri, Tropheryma whipplei, Veillonella dispar, Veillonella parvula, Vibrio cholerae, Vibrio harveyi, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia frederiksenii, Yersinia intermedia, Yersinia pseudotuberculosis
病毒
Betapolyomavirus hominis, Coxsackievirus A4, Coxsackievirus A9, Coxsackievirus B2, Coxsackievirus B3, Coxsackievirus B4, Coxsackievirus B5, Coxsackievirus B6, Echovirus E11, Echovirus E18, Echovirus E2, Echovirus E30, Echovirus E6, Echovirus E9, enterovirus A, Enterovirus A114, Enterovirus A71, enterovirus B, enterovirus D, Enterovirus D68, Hantaan orthohantavirus, Hepatitis B virus, Human adenovirus 1, Human adenovirus 35, Human adenovirus 54, Human adenovirus 7, Human adenovirus B1, Human adenovirus B2, Human alphaherpesvirus 1, Human alphaherpesvirus 2, Human alphaherpesvirus 3, Human astrovirus, Human astrovirus BF34, Human betaherpesvirus 5, Human betaherpesvirus 6, Human betaherpesvirus 6A, Human betaherpesvirus 6B, Human betaherpesvirus 7, Human bocavirus, Human bocavirus 2c, Human bocavirus 3, Human bocavirus 4, Human coronavirus 229E, Human coronavirus HKU1, Human Coronavirus NL63, Human coronavirus OC43, Human gammaherpesvirus 4, Human gammaherpesvirus 8, Human mastadenovirus A, Human mastadenovirus C, Human mastadenovirus D, Human mastadenovirus E, Human mastadenovirus F, Human metapneumovirus, Human orthorubulavirus 2, Human orthorubulavirus 4, Human parvovirus B19, Human respirovirus 1, Human respirovirus 3, Human rotavirus A, Influenza A virus (A/California/07/2009(H1N1)), Influenza A virus (A/goose/Guangdong/1/1996(H5N1)), Influenza A virus (A/Hong Kong/1073/99(H9N2)), Influenza A virus (A/Korea/426/1968(H2N2)), Influenza A virus (A/New York/392/2004(H3N2)), Influenza A virus (A/Puerto Rico/8/1934(H1N1)), Influenza A virus (A/Shanghai/02/2013(H7N9)), Influenza B virus (B/Lee/1940), Influenza C virus, Japanese encephalitis virus, JC polyomavirus, Measles morbillivirus, Middle East respiratory syndrome-related coronavirus, Mumps orthorubulavirus, Norovirus GI, Norovirus GII, Norovirus GIII, Norovirus GIV, Norovirus GV, Paslahepevirus balayani, Poliovirus 1, Respiratory syncytial virus, Rhinovirus A, Rhinovirus B, rhinovirus C, Rubella virus, Saint Louis encephalitis virus, Sapovirus C12, Sapovirus Hu/Dresden/pJG-Sap01/DE, Sapovirus Hu/Nagoya/NGY-1/2012/JPN, Sapovirus Mc10, Severe Acute Respiratory Syndrome Coronavirus, Severe acute respiratory syndrome coronavirus 2, Tick-borne encephalitis virus, West Nile virus, WU Polyomavirus
真菌
Aspergillus clavatus, Aspergillus flavus, Aspergillus fumigatus, Aspergillus nidulans, Aspergillus niger, Aspergillus oryzae, Aspergillus terreus, Aspergillus ustus, Aspergillus versicolor, Blastomyces parvus, Candida albicans, Candida auris, Candida glabrata, Candida parapsilosis, Candida tropicalis, Coccidioides immitis, Cryptococcus gattii VGI, Cryptococcus neoformans, Emmonsia crescens, Histoplasma capsulatum, Malassezia furfur, Pneumocystis jirovecii, Rhizopus arrhizus, Rhizopus microsporus, Saccharomyces cerevisiae, Scedosporium apiospermum, Schizophyllum commune, Sporothrix schenckii, Talaromyces marneffei
寄生蟲
Angiostrongylus cantonensis, Babesia microti, Bartonella bacilliformis, Bartonella henselae, Bartonella quintana, Bartonella vinsonii, Borrelia recurrentis, Borreliella burgdorferi, Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Entamoeba histolytica, Leptospira interrogans, Metamycoplasma hominis, Mycoplasmoides genitalium, Mycoplasmoides pneumoniae, Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, Plasmodium vivax, Rickettsia akari, Rickettsia felis, Schistosoma japonicum, Toxoplasma gondii, Treponema pallidum subsp. pertenue, Ureaplasma parvum, Ureaplasma urealyticum