200亿市场潜力的POCT，能做什么？

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                    <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><section><section><section><section><section data-width="100%"><section><section><p><span>临床检验需求的提升推动着POCT的发展，传统检验方法虽然可以在检验标本量、自动化操作、结果精确度、性能稳定性等方面满足临床检验要求，但在便携性、检测速度、检验流程复杂度等方面却无法得以满足。</span><span>在家庭健康管理及基层医疗机构检验方面，大型检验设备更是难以普及。</span><span>我们以医院市场为例，梳理了医院部分科室对POCT 产品的需求情况：</span></p><p><br  /></p></section></section></section></section></section></section></section><section><section><section><section><section><section><strong><span>心血管内科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><span>可用于心脏损伤标记物检测（包括:肌红蛋白测定、肌钙蛋白I测定、心型脂肪酸结合蛋白测定），心肌酶检测（肌酸激酶-MB 测定），充血性心力衰竭的诊断（NT-proBNP测定），对心肌梗塞、心衰的早期诊断有重要意义。</span></section></section></section></section></section><section><br  /></section><section><p><img src="image/20201014/c74b2f93af086f1cc943e9d30e8d431d_3.jpg" /></p></section><section><br  /></section><section><span></span></section><section><strong><span>呼吸内科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>可进行动脉血气分析（包括：</span><span>动脉血酸碱度、动脉血二氧化碳分压、动脉血氧分压、血浆实际碳酸氢盐和标准碳酸氢盐、动脉血二氧化碳总量、缓冲总碱、剩余碱、动脉血氧饱和度、乳酸）。</span><span>还可用于甲型和乙型流感病毒测定，呼吸道合胞病毒抗原测定，对于“非典”和甲型禽流感病毒也可进行快速检测。</span></p></section></section></section></section><section><br  /></section><section><strong><span>消化内科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>可进行肝功能检查（具体包括：</span><span>血清酶学检查、血清总蛋白、清蛋白测定、血清总胆红素测定、血氨测定），胰腺外分泌功能检查（淀粉酶测定），粪便隐血检查（具体包括：</span><span>便隐血检测、便转铁蛋白检测）。</span></p></section></section></section></section><section><br  /></section><section><strong><span>血液内科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>可进行血红蛋白定量，红细胞沉降率测定，血细胞计数，传染性单核细胞增多症测定，抗人球蛋白测定、人细小病毒B19测定等。</span><span>通过简单的床旁检测，也可初步判断患者是否需要及时输血治疗。</span></p></section></section></section></section><section><br  /></section><p><p><img src="image/20201014/40a78cf147ec70ab1e753bea548f4f3f_7.jpg" /></p></p><section><br  /></section><section><strong><span>内分泌科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>可用于糖代谢紊乱检查（具体包括：</span><span>空腹血糖检测、口服糖耐量试验、糖化血红蛋白测定、β-羟丁氨酸测定、乳酸测定），血脂代谢异常检查（具体包括：</span><span>总胆固醇测定、三酰甘油测定、高密度脂蛋白、低密度脂蛋白测定），血液电解质检查（具体包括：</span><span>钾测定、钠测定、氯测定、钙测定、总二氧化碳测定、阴离子间隙），甲状腺功能测定（具体包括：</span><span>促甲状腺激素、四碘甲状腺原氨酸、游离T4、三碘甲状腺原氨酸、游离T3测定），垂体激素测定（具体包括：</span><span>促卵泡激素测定、黄体生成素测定），人绒毛膜促性腺激素检测。</span></p></section></section></section></section><section><br  /></section><section><strong><span>感染内科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>可进行细菌感染检测（具体包括：</span><span>快速C-反应蛋白检测、降钙素原检测、血清淀粉样蛋白A检测，结核杆菌检测、幽门螺杆菌检测、嗜肺军团菌检测，A 群链球菌测定、金黄色葡萄球菌测定、白色念球菌检测），病毒感染检测（具体包括：</span><span>人类巨细胞病毒抗体测定、风疹病毒抗体检测、单纯疱疹病毒-II抗体检测、人类轮状病毒抗原的测定、腺病毒抗原测定、登革热病毒抗体测定），寄生虫感染检测（具体包括：</span><span>弓形虫抗体检测、恶性疟原虫检测），病毒性肝炎感染检测（具体包括：</span><span>甲型肝炎病毒、乙型肝炎病毒、丙型肝炎病毒、戊型肝炎病毒），性传播疾病检测（具体包括：</span><span>梅毒测定、HIV、淋球菌、沙眼衣原体）</span></p></section></section></section></section><section><br  /></section><section><strong><span>肿瘤内科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>可诊断多种肿瘤标志物（具体包括：</span><span>血管内皮生长因子VEGF测定、甲胎蛋白测定、癌胚抗原测定、前列腺抗原测定、糖类抗原125测定、糖类抗原19-9测定、糖类抗原15-3测定测定、胃蛋白酶原测定、胃泌素17测定、S100蛋白测定）</span></p></section></section></section></section><section><br  /></section><section><strong><span>泌尿科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>可进行尿液常规分析（具体包括：</span><span>尿液理学检查、尿液化学检查），肾小球滤过功能检查（具体包括：</span><span>血肌酐检测、血尿素测定、血尿酸测定），肾小管功能检测（β2微球蛋白测定、α1微球蛋白测定、视黄醇结合蛋白（RBP）测定、N-乙酰-β-D氨基葡萄糖苷酶NAG测定），早期肾损伤检测（尿微量白蛋白测定、胱抑素C测定、中性粒细胞明胶酶相关脂质运载蛋白NGAL测定）。</span></p></section></section></section></section><section><br  /></section><section><strong><span>妇产科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>可用于TORCH-IgM 五项检测、抗卵巢抗体检测、抗透明带抗体检测、抗子宫内膜抗体检测、抗β-HCG的早孕检测、人细小病毒B19检测、沙眼衣原体检测、解脲支原体检测。</span></p></section></section></section></section><section><br  /></section><section><strong><span>儿科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>儿童与成人的就诊方式不同，适合儿童的诊断行为需要轻便，易用，样本需求量少，样本无需预处理，快速得出结论等等。</span><span>项目主要有呼吸道病原体检测系列，像流感病毒、肺炎支原体、肺炎衣原体、腺病毒等；</span><span>炎症检测系列，如CRP、SAA、PCT等。</span><span>POCT 除了结果快速可靠外，父母还可以一直陪伴在孩子身边，随时了解孩子的病情，更好的与医护人员交流，增强了治愈疾病的信心。</span></p></section></section></section></section><section><span></span></section><section><br  /></section><section><strong><span>免疫内科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>可用于变态反应性疾病检查（具体包括：</span><span>过敏原检测、血清总IgE 测定、血清特异IgE 测定、食物不耐受检测），自身免疫性疾病检测（具体包括:类风湿因子检测、抗双链DNA 抗体检测、抗可提取性核抗原抗体检测、抗脱氧核糖蛋白抗体检测、抗核抗体检测、抗CCP检测）。</span></p></section></section></section></section><section><span></span></section><section><br  /></section><section><strong><span>普外科</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>常规凝血功能指标如PT、APTT、Fib、INR、血小板功能、D- 二聚体都能使用POCT 设备检测，可以为急诊手术患者节省时间。</span></p></section></section></section></section><section><br  /></section><section><strong><span>ICU</span></strong></section><section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><p><img src="image/20201014/936d375461487bb9be7487c386ebce38_2.gif" /></p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span>POCT 检测显著缩短了检测周转时间，赢得了对急诊重症患者的治疗决策时间。</span><span>急诊患者的入院前处理关系到患者的抢救与恢复。</span><span>&nbsp;&nbsp;</span></p></section></section></section></section><section><br  /></section><section><section><span>我们以急诊需求为例，简述临床医疗需求对POCT 发展的影响。</span><span>在急诊应用中，医生需要对患者进行紧急评估和再评估，以确定合理治疗措施或分诊。</span><span>与其他科室不同的是，急诊的时间观念极其重要，对治疗时间有着严格要求，早期识别、及早干预对改善患者康复质量、降低致死率和致残率非常关键。</span></section></section><section><br  /></section></section></section></section></section></section><section><section><span>根据卫计委《急诊科建设与管理指南》，急诊科应与检验科室、放射科室毗邻，但传统检验方式仍有可能造成送检不及时、检验人员缺乏不能及时进行、检验结果不能第一时间回复临床等难题。</span></section><section><br  /></section><section><span>以血气生化检测为例，传统实验室检测所需时间可达30分钟以上，而目前的POCT检测时间只需要2分钟左右，因此急诊科室开展POCT 是解决上述困难的重要路径，可大幅缩短检测周转时间，为急诊患者提供黄金抢救时间。</span></section><section><br  /></section><section><span>再以恶性肿瘤为例，作为人类死亡杀手之一，由于病因与发病机制复杂且早期诊断不足，导致诊断和治疗滞后，死亡率高居不下。</span></section><section><br  /></section><section><span>目前，肿瘤检测多数依赖于专业实验室诊断，耗时长且价格昂贵，给患者在时间和经济上带来诸多困难，术后的肿瘤标记物监测不及时，且在医疗资源匮乏地区更难以普及。</span></section><section><br  /></section><section><span>POCT作为一种新的检验模式正在不断发展，因其设备便携，获得结果迅速，可在社区等基层医疗机构以及经济落后地区开展，有利于肿瘤标志物的早期筛查，以期实现对肿瘤早发现、早诊断、早治疗，降低死亡率，并且可对术后患者的肿瘤标记物进行及时的监测。</span></section><section><br  /></section><section><span>早期出现的特异性高的标记物对肿瘤的早期发现至关重要，随着基础研究的深入，越来越多的肿瘤特异性标志物被发现并应用于临床。</span><span>常规的AFP、CEA、PSA项目已在POCT设备上实现，更为广谱的肿瘤早期筛查标志物VEGF项目也已蓄势待发。</span></section><section><br  /></section><section><span>21世纪健康领域的先进理念是“以患者为中心”，是对“以标本为中心”的实验室模式的重大突破。</span></section><section><br  /></section><section><span>临床检验不但要求检验人员与临床医师交流，更要求与患者直接互动，真正实现检测人性化的医疗模式，POCT区别于传统检验最明显的特点是可以与受检者直接沟通交流，更利于了解临床情况，更好地满足临床需求。</span></section><section><br  /></section><section><span>随着医疗模式的转变，家庭保健模式的发展和个体化医疗也提升了对POCT的依赖，由单纯治疗向预防保健、治疗和康复转变。</span></section><section><br  /></section></section><p><span>来源：</span><span>IVD产品速递</span></p><p><span>图片来源：网络</span></p><p><span><br  /></span></p><section 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