仔细翻了一下美国FDA给Abbott AdviseDx SARS-CoV-2 IgG II的仿单与EUA letter
https://www.fda.gov/media/146368/download
https://www.fda.gov/media/146371/download 有以下字句
Prescription Use only
The product is intended for use as an aid in identifying individuals with an
adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
At this time, it is unknown for how long antibodies persist following infection
and if the presence of antibodies confers protective immunity.
Semi-quantitative results from your product should not be interpreted as an
indication or degree of immunity or protection from reinfection.
Samples should only be tested from individuals that are 15 days or more post
symptom onset.
医师开单使用
本产品的结果是拿来指示 最近的SARS-CoV-2病毒感染或先前有感染过
目前并不知道感染后抗体能持续多久,以及抗体是否代表了保护性免疫力
半定量的结果不应该被解释成免疫力或避免再次感染的保护力
只应该拿来检测有症状后15天或以后的人的检体
(另外,通篇找不到vaccine的字样)