仔細翻了一下美國FDA給Abbott AdviseDx SARS-CoV-2 IgG II的仿單與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.
醫師開單使用
本產品的結果是拿來指示 最近的SARS-CoV-2病毒感染或先前有感染過
目前並不知道感染後抗體能持續多久,以及抗體是否代表了保護性免疫力
半定量的結果不應該被解釋成免疫力或避免再次感染的保護力
只應該拿來檢測有症狀後15天或以後的人的檢體
(另外,通篇找不到vaccine的字樣)