TBG Biotechnology Corp.
TBG SARS-CoV-2 IgG / IgM Rapid Test Controls Set
Version 1.2
1 of 20
TBG Biotechnology Corp.
TBG SARS-CoV-2 IgG / IgM Rapid Test Control Set
Catalog No. 20010-C
Format: 2 vials with 0.1ml per vial.
1.
Intended Use:
The TBG SARS-CoV-2 IgG / IgM Rapid Test Controls set are intended for
use as quality controls to ensure proper performance of the TBG SARS-CoV-2 IgG / IgM
Rapid Test Kit (Cat. No. 20010, TBG Taiwan).
2.
Specifications:
This product contains 2 vials with 0.1ml of volume and for single use.
3.
Components Included:
3.1.
Positive Control x 1 vial. 0.1ml per vial. This vial contains IgG and IgM antibodies
against SARS-CoV-2 diluted in pooled COVID-19 free human serum. The
concentration of each antibody is 10ng/µL.
3.2.
Negative Control x 1 vial. 0.1ml per vial. This vials contains COVID-19 free human
serum.
3.3.
Instruction For Use: 1 copy of the instruction for use is included with each kit.
4.
Storage and Handling Conditions:
This product is stable for 1 month, when stored at 2-
8
℃
.
5.
Protocols:
5.1.
Remove the product from storage and allow thawing at room temperature (25
±
5
℃)
.
5.2.
Once thawed, use the product within 15 minutes, according to the instructions
provided in the TBG SARS-CoV-2 IgG / IgM Rapid Test Kit (Cat. No. 20010, TBG
Taiwan).
5.3.
These products are meant for single use and should be used within 15 minutes
after thaw.
5.4.
The Positive Control should result in a TBG SARS-CoV-2 IgG / IgM Rapid Test
positive reaction with visible IgG, IgM, and Control Lines.
5.5.
The Negative Control should result in a TBG SARS-CoV-2 IgG / IgM Rapid Test
reaction with only a visible Control Line.
5.6.
After use, dispose of any remaining product as biological hazardous waste.
6.
Precaution
6.1.
For Emergency Use Authorization only.
6.2.
For in vitro diagnostic use only. This product has not been FDA cleared or
approved; This product has been authorized by FDA under an EUA for use by