The antibody pairs are the critical reagents for antigen test kits. However, for the antigen test development, the current dilemma is how to choose a sample for the assay development. Most of the scientists use recombinant antigen proteins as spiked in samples for the assay development due to the limitation caused by biosafety reasons for getting access to patient samples in the early discovery stage. The deficiency of this method is that the recombinant proteins may not best represent the structure of the virus. Additionally, the lysis of the swab samples will cause unwanted breakage of the proteins, which is the recombinant protein won’t be able to replicate. In summary, the recombinant protein is not sufficient enough when screening for the antibody pairs.
The most reliable way to evaluate your antigen test is using inactivated virus for the assay development. In order to support the IVD product development, ACRO developed a series of high-quality recombinant protein reagents, especially the antibody pairs. ACRO’s antibody pairs have been verified using inactivated virus samples. The sensitivity of the sandwich ELISA can be as low as 12pg/mL. The titer, which was determined using our LFA assay, is as low as 100 CCID50.
The titer determined by using our LFA assay is as low as 100 CCID50.
>> Verified by inactivated virus
Fig 1 Inactivated virus verified results
The sensitivity of the sandwich ELISA can be as low as 12pg/mL.
>> Verified by Recombinant Antigen Using ELISA
Fig 2 Immobilized Anti- SARS-CoV-2 Nucleocapsid antibody, mouse Mab (Cat. No. NUN-S60) at 4 μg/mL, add increasing concentrations of SARS-CoV-2 Nucleocapsid protein and then add Biotinylated Anti- SARS-CoV-2 Nucleocapsid antibody, mouse Mab (Cat. No. NUN-S47). Detection was performed using HRP-conjugated streptavidin with sensitivity of 12 pg/mL
Fig 3 Demonstration of the specificity of Anti-SARS-CoV-2 N antibody pairs (Cat. No. NUN-S60 & Cat. No. NUN-S47) to the Nucleocapsid protein.