Predictive Technology Group Inc (PRED)

[Brian903]

We all good on composite test!!!!!!!!!!!!!!!!!!!!!!

Agreement with a composite reference method
The performance of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test
was compared to a composite reference method that includes a RT-PCR method
and a chemiluminescence immunosorbent assay (CLIA). A total of 900 serum
samples (287 positive and 613 negative) were tested with the Assurance AB™
COVID-19 IgM/IgG Rapid Antibody Test and compared to a composite reference
method. The agreement results are presented in the table below.
Comparator
(Composite Method) Subtotal
Pos Neg
Assurance
AB™ COVID19 IgM/IgG
Rapid
Antibody Test
Pos
IgG+/IgM+ 15 0 15
IgG-/IgM+ 31 0 31
IgG+/IgM- 221 0 221
Neg IgG-/IgM- 20 613 633
Subtotal 287 613 900
Positive Percent Agreement (PPA): 267/287 (93.0%); (95% CI: 89.4 - 95.7%)
Negative Percent Agreement (NPA): 613/613 (100.0%); (95% CI: 99.4 -100.0%)


Agreement with a chemiluminescence immunosorbent assay (CLIA)
A total of 900 samples were tested comparing the Assurance AB™ COVID-19
IgM/IgG Rapid Antibody Test to a reference antibody test. The agreement results
of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test to an antibody
reference assay are presented below.
IgM Agreement
Comparator (CLIA) Subtotal Pos Neg
Assurance
AB™ COVID-19
IgM/IgG Rapid
Antibody Test
Pos 44 2 46
Neg 5 849 854
Subtotal 49 851 900
Positive Percent Agreement (PPA): 44/49 (89.8%); (95% CI: 77.8-96.6%)
Negative Percent Agreement (NPA): 849/851 (99.8%); (95% CI: 99.2-100%)
IgG Agreement
Comparator (CLIA) Subtotal Pos Neg
Assurance
AB™ COVID-19
IgM/IgG Rapid
Antibody Test
Pos 230 6 236
Neg 21 643 664
Subtotal 251 649 900
Positive Percent Agreement (PPA): 230/251 (91.6%); (95% CI: 87.5-94.8%)
Negative Percent Agreement (NPA): 643/649 (99.1%); (95% CI: 98.0-99.7%)