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美国紧急上市32种试剂盒,它们有什么区别?

美国紧急上市32种试剂盒,它们有什么区别?

Sy Mukherjee 2020年04月15日
专家称,这些不同的试剂盒在科学上和用法上存在一些重要的差异。

短短一个月前,美国市面还只有两种可用的新冠肺炎检测试剂盒。

而现在,美国已经有了32种检测试剂盒。美国食品与药品管理局(FDA)的网站上已经列出了获得紧急授权的全部32种试剂盒的名录,而且授权的步伐还在加快。

美国的疫情之所以发展到如此严重的地步,也是靠一连串失败“作”出来的。美国疾控中心(CDC)研发的第一种复合试剂盒也是个失败品,有可能导致检测结果不准。不过美国也不知道是怎么想的,非要选择自己开发检测试剂盒,而不是使用其他国家已经在使用的产品。

美国卫生与公众服务部(HHS)也发现了疾控中心的试剂盒不靠谱,它也意识到,在疾控中心解决自研试剂盒的检测准确度问题之前,美国将不得不依赖于其他检测手段。所以这种责任只能落在私营企业身上,好让它们利用自己的技术来开发商用的检测手段。

随后,FDA对多家私营企业和州立卫生部门开发的试剂盒颁发了紧急授权。严格来说,这种授权并非技术上的批文——通常情况下,一种新的检测手段要获得FDA的批文,往往需要一年到一年半的时间。但考虑到疫情的严重性,FDA已经允许多家机构先行部署他们的测试手段。

2月4日,美国疾控中心研发的那款有缺陷的试剂盒获得了FDA的授权。接下来,纽约州卫生部门研发的一款试剂盒也于2月29日获得了FDA的授权。

两个星期之后,几乎每天都有新的试剂盒获得紧急授权。首先中奖的是罗氏公司,这次授权对于该公司具有里程碑式的意义,该公司在大约6周的时间里就完成了第一支商用新冠肺炎试剂盒的研发。罗氏公司向《财富》杂志表示,该公司目前每周可生产40万支试剂盒。

其他生产试剂盒的著名企业还包括:塞默飞世尔科技、LabCorp、Quest Diagnostics、雅培、Cepheid、仙丽施、Becton Dickinson等等。就在4月8日,还有帝基生物(Diacarta)开发的一款试剂盒获批上市。

医疗用品经销商巨头汉瑞祥(Henry Schein)也有一款由合作商研发的试剂盒,但由于检测类型不同,因此并不需要FDA的紧急授权。

雅培公司诊断部门的研发副总约翰·弗雷尔斯对《财富》杂志介绍道,这些不同的试剂盒在科学上和用法上也存在一些重要的差异。很多试剂盒都是基于所谓的“聚合酶链式反应”(简称PCR技术),比如美国疾控中心和罗氏公司研发的试剂盒。还有一些是所谓的“血清检测分析”试剂盒,也就是靠验血。还有一些试剂盒使用的是这两种技术的某种变体。

弗雷尔斯说:“商业公司已经开始在他们的平台上推出基于PCR技术的试剂盒了。”他还表示,美国各个联邦实验室、州立实验室和地方实验室必须有合适的设备,才可以处理各种检测。虽然检测试剂盒能够发现新冠病毒,但如果实验室(不管是医院、急救中心还是其他医疗机构的实验室)没有合适的基础设备,它也起不到多大的用处。

一套PCR系统每天可以做几百次检测,鉴于美国目前的检测数量严重不足,提高检测量已经成了急需解决的一个问题。另外,PCR技术还能够检测多种传染病,所以很多大型医院都已经有了这种设备。

但PCR技术也不是没有缺点。它必须提取患者的鼻咽拭子送检,这个过程可能会耗时几个小时甚至几天。

不过,雅培公司现在已经推出了一种名叫ID NOW的新型试剂盒,它也是一种基于PCR技术的分子检测手段,并且已经于3月27日获得了FDA的紧急授权。使用这种试剂盒,只需要5分钟就能检测出阳性,13分钟就可以检测出阴性,而且就算在地区医院、紧急诊所乃至医生的办公室里也能做检测,真正起到了“即时检测”的效果。检测所需的试备也更加便携。

在谈到分子检测技术时,弗雷尔斯表示:“下一波的检测手段还是以检测病毒的遗传物质和感染活性为重点,它将可以实现‘即时检测’。不过在实际中,大概每小时可以进行4次检测。”

那么,不同的试剂盒为什么在测试时间上有这么大的差异?为了检测病毒,首先要对患者样本中病原体的基因序列进行扩增。要做到这一点,PCR测试必须在多个温度下循环进行,也就是要对样本先加热再冷却。而ID NOW使用了一种“等温”技术,它可以在一个较稳定的温度下进行基因序列的扩增过程,从而更快地获得检测结果。

弗雷尔斯表示,雅培公司在短短4到6周的时间里就开发出了它的检测手段。“我从来没有见过这样的事。”雅培表示,公司计划进一步扩大产能,目标是每天提供5万个试剂盒。

另外,市面上还有不少“血清”试剂盒,也就是通过验血,检测血清中是否有感染了新冠病毒后产生的抗体。血清测试还有另一种用途,就是可以判断某人是否已经感染了新冠病毒,并且已经恢复了,哪怕他们是轻症甚至是无症状者。据报道,美国疾控中心已经从4月4日起部署这种试剂盒了。汉瑞祥公司的“即时检测”试剂盒也属于一种血清检测,仙丽施公司开发的试剂盒也属于这一类。

这些测试手段的目的虽然不同,但都很重要。它们很可能会多管齐下地用于新冠病毒的检测。

贝勒医学院的医学教授、病毒学专家佩德罗·皮德拉说:“要使用哪种试剂盒,很大程度上取决于你的设备,或者你的实验室里有什么。”

但是,市面上突然出现了这么多种试剂盒,我们怎么知道自己用的是哪一种,又怎么知道它是不是有效呢?皮德拉本人也负责一家新冠病毒检测实验室,他比这种情况比作炒意面,最终产品才是最重要的,至于制作它的原料是什么,则并不重要。

他表示:“你所接受的测试很大程度上是在幕后进行的。比方说,除非你是一位真正的意面专家,否则你也并不真正了解它的成份是什么。”

要想辨别哪种检测手段最有效,是需要一些时间的——这不仅是对新冠病毒,对任何疾病都是如此。不过皮德拉表示,目前关于疫情的信息在医学界的传播速度很快,医疗供应商们会知道他们应该采购哪种试剂盒。

他说:“任何获得紧急授权的东西,都需要一些数据支持。随着时间的推移,人们会知道哪种试剂盒的表现更好,哪种表现较差。早在新冠病毒出现之前,这种情况就经常发生了——你的医疗服务供应商是非常精明的。”

不过,检测能力的提高,并不代表什么人都能得到检测。随着美国确诊病例不断攀升,美国各地的医院都承受着巨大压力,而且各州根据当前的感染者人数都制订了不同的公共卫生政策,因此,一个人如果想获得新冠病毒检测,可能得表现出严重的新冠肺炎症状才行。

尽管美国疾控中心已经发布了关于检测主体资格的指导意见,不过疾控中心同时也指出,“是否进行检测的决定,应由各州和地方卫生部门及/或临床医生个人作出。”

在一些疫情最严重的州,比如加利福尼亚和纽约,一些医院正在限制对医护人员、重症患者以及高危人群(比如老年人)做检测。

特朗普政府曾计划取消联邦政府对全美41个新冠肺炎检测点的支持,不过在收到了投诉后,美国卫生与公众服务部已表示,将继续为这些检测点提供资金。此外,特朗普政府本周还出台了新的指导意见,将允许执业药剂师采购和执行新冠病毒测试,并指出老百姓去当地药房做测试,要比开车去医院或指定检测点更方便。

随着抗体血清检测试剂盒供给的增加,美国的检测方法有可能再次调整。这一点也是很重要的,原因有很多:首先,如果美国的疫情持续居高不下,那至少要筛查出哪些人已经康复了,并产生了免疫力,好让他们尽快重返工作岗位,重振美国经济。因为他们再次感染的风险是比较低的。

虽然关于新冠肺炎的康复过程,医学界还有很多事搞不清楚,不过美国国家热带医学院院长彼得·霍特兹认为,新冠肺炎康复者获得免疫力是很有可能的。“从以前的SARS(由另一种冠状病毒引起)疫情看,康复者都产生了两年以上的抗体。所以我并不担心那些已经被感染并且产生了抗体反应的人。”

新冠病毒检测另一个令人困惑的问题,就是它的成本到底是多少。接受《财富》杂志采访的多家公司都拒绝就试剂盒的定价和分销策略发表评论。

理论上来说,很多这些检测对患者都应该是免费的。但是对于患者本人究竟应该为一次测试花多少钱,在美国依然没有定论。有好几家公司指出,这既取决于患者的医保状况,也取决执行检测的实验室。当然,此外还得取决于千创百孔的美国医疗体系里的很多其他复杂因素。

一些主要的健康保险公司,包括Cigna和Humana已经同意免除新冠肺炎治疗的自付费用,CVS健康(CVS Health)旗下的安泰保险(Aetna)也做出了类似的承诺,但力度有限。

但对于那些买了其他类型的保险,或者根本没有医保的人来说,情况就不那么明朗了。目前在民主党党内初选中呼声最高的美国前副总统拜登已经呼吁国会通过一项法案,允许所有新冠肺炎患者免费接受检测和治疗。特朗普政府也宣布了一项计划,将帮助医院支付那些无医保新冠肺炎患者的治疗费用。不过美国在此次疫情中的表现已经表明,这些目前都不靠谱。

还有一个问题是,如果一个人生病了,想要寻求治疗,但检测的结果是没有感染新冠病毒,那检测费谁出呢?如果他们在接受检测前已经住院了,住院费又由谁来出?

“病人仍然可能从医生那里收到大额的医药费账单。那些寻求治疗但却没有确诊新冠病毒的人,可能还得支付全部费用。”上周,无党派的凯撒家庭基金会(KFF)常务副会长拉里·莱维特在推特上这样写道。

译者:隋远洙

短短一个月前,美国市面还只有两种可用的新冠肺炎检测试剂盒。

而现在,美国已经有了32种检测试剂盒。美国食品与药品管理局(FDA)的网站上已经列出了获得紧急授权的全部32种试剂盒的名录,而且授权的步伐还在加快。

美国的疫情之所以发展到如此严重的地步,也是靠一连串失败“作”出来的。美国疾控中心(CDC)研发的第一种复合试剂盒也是个失败品,有可能导致检测结果不准。不过美国也不知道是怎么想的,非要选择自己开发检测试剂盒,而不是使用其他国家已经在使用的产品。

美国卫生与公众服务部(HHS)也发现了疾控中心的试剂盒不靠谱,它也意识到,在疾控中心解决自研试剂盒的检测准确度问题之前,美国将不得不依赖于其他检测手段。所以这种责任只能落在私营企业身上,好让它们利用自己的技术来开发商用的检测手段。

随后,FDA对多家私营企业和州立卫生部门开发的试剂盒颁发了紧急授权。严格来说,这种授权并非技术上的批文——通常情况下,一种新的检测手段要获得FDA的批文,往往需要一年到一年半的时间。但考虑到疫情的严重性,FDA已经允许多家机构先行部署他们的测试手段。

2月4日,美国疾控中心研发的那款有缺陷的试剂盒获得了FDA的授权。接下来,纽约州卫生部门研发的一款试剂盒也于2月29日获得了FDA的授权。

两个星期之后,几乎每天都有新的试剂盒获得紧急授权。首先中奖的是罗氏公司,这次授权对于该公司具有里程碑式的意义,该公司在大约6周的时间里就完成了第一支商用新冠肺炎试剂盒的研发。罗氏公司向《财富》杂志表示,该公司目前每周可生产40万支试剂盒。

其他生产试剂盒的著名企业还包括:塞默飞世尔科技、LabCorp、Quest Diagnostics、雅培、Cepheid、仙丽施、Becton Dickinson等等。就在4月8日,还有帝基生物(Diacarta)开发的一款试剂盒获批上市。

医疗用品经销商巨头汉瑞祥(Henry Schein)也有一款由合作商研发的试剂盒,但由于检测类型不同,因此并不需要FDA的紧急授权。

雅培公司诊断部门的研发副总约翰·弗雷尔斯对《财富》杂志介绍道,这些不同的试剂盒在科学上和用法上也存在一些重要的差异。很多试剂盒都是基于所谓的“聚合酶链式反应”(简称PCR技术),比如美国疾控中心和罗氏公司研发的试剂盒。还有一些是所谓的“血清检测分析”试剂盒,也就是靠验血。还有一些试剂盒使用的是这两种技术的某种变体。

弗雷尔斯说:“商业公司已经开始在他们的平台上推出基于PCR技术的试剂盒了。”他还表示,美国各个联邦实验室、州立实验室和地方实验室必须有合适的设备,才可以处理各种检测。虽然检测试剂盒能够发现新冠病毒,但如果实验室(不管是医院、急救中心还是其他医疗机构的实验室)没有合适的基础设备,它也起不到多大的用处。

一套PCR系统每天可以做几百次检测,鉴于美国目前的检测数量严重不足,提高检测量已经成了急需解决的一个问题。另外,PCR技术还能够检测多种传染病,所以很多大型医院都已经有了这种设备。

但PCR技术也不是没有缺点。它必须提取患者的鼻咽拭子送检,这个过程可能会耗时几个小时甚至几天。

不过,雅培公司现在已经推出了一种名叫ID NOW的新型试剂盒,它也是一种基于PCR技术的分子检测手段,并且已经于3月27日获得了FDA的紧急授权。使用这种试剂盒,只需要5分钟就能检测出阳性,13分钟就可以检测出阴性,而且就算在地区医院、紧急诊所乃至医生的办公室里也能做检测,真正起到了“即时检测”的效果。检测所需的试备也更加便携。

在谈到分子检测技术时,弗雷尔斯表示:“下一波的检测手段还是以检测病毒的遗传物质和感染活性为重点,它将可以实现‘即时检测’。不过在实际中,大概每小时可以进行4次检测。”

那么,不同的试剂盒为什么在测试时间上有这么大的差异?为了检测病毒,首先要对患者样本中病原体的基因序列进行扩增。要做到这一点,PCR测试必须在多个温度下循环进行,也就是要对样本先加热再冷却。而ID NOW使用了一种“等温”技术,它可以在一个较稳定的温度下进行基因序列的扩增过程,从而更快地获得检测结果。

弗雷尔斯表示,雅培公司在短短4到6周的时间里就开发出了它的检测手段。“我从来没有见过这样的事。”雅培表示,公司计划进一步扩大产能,目标是每天提供5万个试剂盒。

另外,市面上还有不少“血清”试剂盒,也就是通过验血,检测血清中是否有感染了新冠病毒后产生的抗体。血清测试还有另一种用途,就是可以判断某人是否已经感染了新冠病毒,并且已经恢复了,哪怕他们是轻症甚至是无症状者。据报道,美国疾控中心已经从4月4日起部署这种试剂盒了。汉瑞祥公司的“即时检测”试剂盒也属于一种血清检测,仙丽施公司开发的试剂盒也属于这一类。

这些测试手段的目的虽然不同,但都很重要。它们很可能会多管齐下地用于新冠病毒的检测。

贝勒医学院的医学教授、病毒学专家佩德罗·皮德拉说:“要使用哪种试剂盒,很大程度上取决于你的设备,或者你的实验室里有什么。”

但是,市面上突然出现了这么多种试剂盒,我们怎么知道自己用的是哪一种,又怎么知道它是不是有效呢?皮德拉本人也负责一家新冠病毒检测实验室,他比这种情况比作炒意面,最终产品才是最重要的,至于制作它的原料是什么,则并不重要。

他表示:“你所接受的测试很大程度上是在幕后进行的。比方说,除非你是一位真正的意面专家,否则你也并不真正了解它的成份是什么。”

要想辨别哪种检测手段最有效,是需要一些时间的——这不仅是对新冠病毒,对任何疾病都是如此。不过皮德拉表示,目前关于疫情的信息在医学界的传播速度很快,医疗供应商们会知道他们应该采购哪种试剂盒。

他说:“任何获得紧急授权的东西,都需要一些数据支持。随着时间的推移,人们会知道哪种试剂盒的表现更好,哪种表现较差。早在新冠病毒出现之前,这种情况就经常发生了——你的医疗服务供应商是非常精明的。”

不过,检测能力的提高,并不代表什么人都能得到检测。随着美国确诊病例不断攀升,美国各地的医院都承受着巨大压力,而且各州根据当前的感染者人数都制订了不同的公共卫生政策,因此,一个人如果想获得新冠病毒检测,可能得表现出严重的新冠肺炎症状才行。

尽管美国疾控中心已经发布了关于检测主体资格的指导意见,不过疾控中心同时也指出,“是否进行检测的决定,应由各州和地方卫生部门及/或临床医生个人作出。”

在一些疫情最严重的州,比如加利福尼亚和纽约,一些医院正在限制对医护人员、重症患者以及高危人群(比如老年人)做检测。

特朗普政府曾计划取消联邦政府对全美41个新冠肺炎检测点的支持,不过在收到了投诉后,美国卫生与公众服务部已表示,将继续为这些检测点提供资金。此外,特朗普政府本周还出台了新的指导意见,将允许执业药剂师采购和执行新冠病毒测试,并指出老百姓去当地药房做测试,要比开车去医院或指定检测点更方便。

随着抗体血清检测试剂盒供给的增加,美国的检测方法有可能再次调整。这一点也是很重要的,原因有很多:首先,如果美国的疫情持续居高不下,那至少要筛查出哪些人已经康复了,并产生了免疫力,好让他们尽快重返工作岗位,重振美国经济。因为他们再次感染的风险是比较低的。

虽然关于新冠肺炎的康复过程,医学界还有很多事搞不清楚,不过美国国家热带医学院院长彼得·霍特兹认为,新冠肺炎康复者获得免疫力是很有可能的。“从以前的SARS(由另一种冠状病毒引起)疫情看,康复者都产生了两年以上的抗体。所以我并不担心那些已经被感染并且产生了抗体反应的人。”

新冠病毒检测另一个令人困惑的问题,就是它的成本到底是多少。接受《财富》杂志采访的多家公司都拒绝就试剂盒的定价和分销策略发表评论。

理论上来说,很多这些检测对患者都应该是免费的。但是对于患者本人究竟应该为一次测试花多少钱,在美国依然没有定论。有好几家公司指出,这既取决于患者的医保状况,也取决执行检测的实验室。当然,此外还得取决于千创百孔的美国医疗体系里的很多其他复杂因素。

一些主要的健康保险公司,包括Cigna和Humana已经同意免除新冠肺炎治疗的自付费用,CVS健康(CVS Health)旗下的安泰保险(Aetna)也做出了类似的承诺,但力度有限。

但对于那些买了其他类型的保险,或者根本没有医保的人来说,情况就不那么明朗了。目前在民主党党内初选中呼声最高的美国前副总统拜登已经呼吁国会通过一项法案,允许所有新冠肺炎患者免费接受检测和治疗。特朗普政府也宣布了一项计划,将帮助医院支付那些无医保新冠肺炎患者的治疗费用。不过美国在此次疫情中的表现已经表明,这些目前都不靠谱。

还有一个问题是,如果一个人生病了,想要寻求治疗,但检测的结果是没有感染新冠病毒,那检测费谁出呢?如果他们在接受检测前已经住院了,住院费又由谁来出?

“病人仍然可能从医生那里收到大额的医药费账单。那些寻求治疗但却没有确诊新冠病毒的人,可能还得支付全部费用。”上周,无党派的凯撒家庭基金会(KFF)常务副会长拉里·莱维特在推特上这样写道。

译者:隋远洙

Just one month ago, there were only two available COVID-19 tests in the country.

Now, that number stands at 32. The FDA's website lists all of the various COVID-19 diagnostics which have been granted emergency authorization—the pace of authorizations has ramped up rapidly.

A perfect storm of failures brought the U.S. to this point. The first coronavirus test, a complex diagnostic developed by the Centers for Disease Control (CDC), simply didn't work, leading to the possibility of inaccurate results. The U.S. chose to develop its own diagnostic rather than use the tests other countries were already using, although the reasoning behind why is unclear.

The Department of Health and Human Services (HHS), cognizant of the CDC test's problems, realized that other tests would have to hit the scene as the agency fixed its own diagnostic. That responsibility would fall to organizations like private firms which could develop commercial tests using their own technologies.

Then came the cascade of FDA emergency use authorizations for such private firms and state health departments. These aren't technically approvals—the approval process for a new diagnostic usually takes somewhere from 12 to 18 months. But given the scope of the coronavirus crisis, multiple firms have been given permission to deploy their own tests.

The CDC's flawed test was authorized on February 4. Next, a test from the New York State Department of Health on February 29.

Two weeks later, emergency authorizations were being granted on a nearly daily basis. First came a milestone authorization for Roche, which developed the first commercially available COVID-19 test in just about six weeks. The company told Fortune it could fuel 400,000 tests per week.

Other prominent companies with tests include: Thermo Fisher Scientific, LabCorp, Quest Diagnostics, Abbott, Cepheid, Cellex, Becton Dickinson, and many others. The latest authorization came on April 8 for a testing kit developed by DiaCarta.

Medical distributor giant Henry Schein also has a test, manufactured by a partnering firm, that didn't require emergency authorization due to the type of test that it is.

There are key scientific—and practical—differences among these various diagnostics. Many of the tests, such as the CDC's and Roche's, are so-called "PCR chain technology" tests. Some are "serology" tests, or blood tests. Some use different variations of these technologies. John Frels, vice president of R&D at Abbott Diagnostics, explained the science to Fortune.

"Commercial companies started coming out with PCR tech-based tests on their platforms," he said, referencing the fact that various federal, state, and local labs need to have the proper equipment to process various kinds of tests. While a test may be able to sniff out the coronavirus, it wouldn't do much good if a laboratory—whether in a hospital, urgent care clinic, or other points of care—doesn't have the right base equipment.

PCR systems are able to churn out hundreds of tests per day—a critical issue to address given America's dearth of coronavirus testing. They're also extremely versatile in being able to detect multiple kinds of infectious diseases, which is why so many major centers already have the equipment.

But there are tradeoffs. Such tests typically require throat and nasal swabs which must be sent off for testing. That can be a time-consuming process taking hours or days.

But with tests such as Abbott's ID NOW COVID-19 diagnostic—a molecular test along the lines of PCR tests, which was given emergency authorization on March 27—you might be able to get a positive result within five minutes and a negative result within 13 minutes at a regional hospital, a physician's office, or an urgent care clinic, which is what the industry dubs as "point-of-care" testing. The equipment required to run the test is also much more portable.

"The next tranche of tests, which are still tests meant to detect the virus' genetic material and active infections, can be done at point of care. But that may be more along the lines of four tests per hour," said Frels of molecular tests.

Why such a big difference in testing time? In order to detect a virus, a test needs to amplify the genetic sequence of the pathogen in a patient's sample. To do that, PCR tests must cycle through multiple temperatures, heating up and then cooling down the sample. ID NOW uses something called "isothermal" technology, which can conduct this amplification process at a more consistent temperature and thus deliver results much faster.

Frels said that Abbott developed its test in a four-to-six week timeframe: "I've never seen anything like this." The company said it plans to ramp up manufacturing to facilitate the delivery of 50,000 tests per day.

And then there's the slew of "serology" tests—blood tests which detect antibodies that were created in response to a coronavirus infection. A serological test has a different use case since it can reveal whether or not someone has contracted COVID-19 in the past and recovered from it, even if they were largely asymptomatic. The CDC reportedly begun deploying such tests as of April 4. Henry Schein's point of care diagnostic is also a serology test, as is a test developed by the biotechnology firm Cellex.

These various tests serve distinct, but important, purposes. And they'll likely have to be used in a multi-pronged approach to coronavirus diagnostics.

"A lot is based on what your facility or your lab has," Pedro Piedra, a Baylor College of Medicine professor and virology specialist, said.

But what can we make of all these tests suddenly coming on to the market—and how would you know which one you're getting, and whether or not it's effective? Piedra, who runs a lab conducting COVID-19 tests, compares the situation to the specter of, well, lasagna. The most important element is the end product, not necessarily the ingredients which go into making it.

"The kind of test you’re getting is largely behind the scenes," he said. "Unless you’re a true connaisseur of lasagna, you don’t really know what the ingredients are."

It can take some time to discern which tests are most effective—not just for coronavirus, but for any disease. But Piedra said that information spreads quickly amongst the medical community and informs health care providers about which tests they should be stocking up on.

"Anything given an emergency authorization needs some data," he said. "Over time, it will be known which ones perform better and which ones perform worse. That situation happened routinely long before this coronavirus came around—your health care provider will be very astute."

But just because testing capacity is ramping up doesn't mean that just anyone can get a test. With the growing number of reported U.S. cases putting a strain on hospitals—as well as divergent public health policies among states based on their number of current infections—one may have to be seriously ill with COVID-19 in order to be given a coronavirus test.

Although the CDC has issued guidance for who should qualify for testing, the agency has also stated that "decisions about testing are at the discretion of state and local health departments and/or individual clinicians."

In some of the hardest hit states such as California and New York, some hospitals are limiting testing to health care workers, those with advanced cases of the disease, and highest-risk populations such as the elderly.

The Trump administration had planned to end federal support for 41 COVID-19 testing sites around the country, but after complaints, the Department of Health and Human Services said it would continue funding. Additionally, the Trump administration issued new guidance this week that would allow licensed pharmacists to order and administer COVID-19 tests, noting that a local pharmacy would be easier to access than having to drive to a hospital or testing site.

Testing access may change as the availability of antibody blood tests ramps up, which is important for a number of reasons. Should the wave of serious COVID-19 cases continue, it would be important to identify those who have recovered and developed an immunity so that they might be able to go back into work and rev up the U.S. economy since they may have a lower chance of re-infection.

While there are still plenty of unknowns about what recovery looks like, Peter Hotez, dean for the National School of Tropical Medicine at Houston's Baylor College of Medicine, believes immunity is likely the case. "From the previous SARS epidemic [caused by a different strain of coronavirus] it was pretty clear people would have antibodies for up to two years and possibly even longer than that. So I’m not as worried about people who have been infected and have developed an antibody response."

The other confusing element behind COVID-19 testing is how much it costs. Multiple firms Fortune spoke with declined to comment on their pricing and distribution strategies.

Theoretically, many of these tests should be free for patients, but there are open questions about how much a patient may be forced to pay out of pocket for a test. Several companies pointed out that it would depend on a patient's insurance status, the specific lab conducting their test, and a host of other complex factors driven by America's fragmented health system.

A number of major health insurance firms including Cigna and Humana have agreed to waive out-of-pocket costs for COVID-19 treatment; Aetna, owned by CVS Health, has made a similar, though more limited, commitment.

But the situation is more unclear for those with other kinds of insurance or no insurance at all. Former Vice President Joe Biden, the overwhelming favorite to win the Democratic nomination for president, has called for Congress to pass a bill that would shield any coronavirus patient from having to pay out of pocket for testing or medical care. The Trump administration has released a plan to help hospitals pay for the cost of treating uninsured coronavirus patients—but, as with everything COVID-19, there are caveats abound.

And then there's the question of when someone is sick and seeks care but turns out not to have coronavirus, or who bears the burden of the costs of a hospital stay before they receive testing.

"Patients could still get big bills from doctors. People who seek care and end up not having COVID-19 could still end up owing full charges," wrote Larry Levitt, executive vice president at the nonpartisan Kaiser Family Foundation (KFF), in a tweet last week.

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