Page 4 - HSP-Assure Test Booklet FDA Auth Booklet - FINAL 7_2020RV2
P. 4
The Dataset (New changes to THIS test you need to be aware of:
External Negative and Positive Control Further Explained
Negative Controls: Lypholized human serum samples
Positive Controls: Lypholized IgG and IgM against SARS-CoV-2
2 negative control vials are supplied. Reconstitute each negative control vial with 30 ul purified
water. Transfer one reconstituted 30 ul negative control to the positive control vial to make
ready-to-use positive control. Controls can be used like a serum sample. Store reconstituted
controls at 4°C
