COVVID- 19 Testing – Current Problems
From a QA/QC chemist/biochemist perspective , I have been following expressed concerns about the quality, precision ( repeatability/reproducibility at 95% confidence limits) and accuracy of the COVID-19 testing. There is little to no round robin testing on known and unknown samples, no standardized test procedure; we have many different manufactured tests with known stated precision and accuracy problems.
Questions to be Answered about Current Test Procedures
Before running out and getting tested some questions I have asked Test Manufacturers regarding the above parameters and the following issues:
A test result only represents a moment in time.
False Negative: How much time after a person is infected by CoV19 does it take the PCR-RNA test to indicate a positive result? What is the lower detection limit of this test? If it requires a sufficient amount of time for enough virion particles to reproduce to obtain sufficient RNA concentration, what is that time and how much virion must be present to elicit a positive result?
If these parameters have not been determined and compared and standardized between all manufacturers of this “method”, the test results from using this method are unreliable and suspect.
Example: I am asymptomatic or pre-symptomatic carrier and suspect that I was exposed to a known carrier who tested positive because he exhibited all known symptoms and is self-quarantined.
I get tested and initial result is (false) negative because a sufficient concentration of virions was not present at the time the nose or saliva test was taken. I leave with a smile, thinking I’m safe but I begin experiencing symptoms 2-14 days later. Are “negative” samples retained to be reanalyzed at later date to verify/refute “negative results”?
Antibody IgG/IgM test – Has this test been standardizated, 95% precision been determined?
Is repeatability within a specific lab or reproducibility between labs utilizing the same test procedure given there are now 8 accepted CDC tests.
We need to determine 95% confidence and accuracy via round robin testing on a standardized test procedure before we can put any confidence in test results.
I realize that our health and economy rests on establishing who’s got the active virus and who’s built immunity but until we establish the error associated with these two tests procedures, we are fooling ourselves into a false sense of security.
Other Proposed Test Solutions
I believe that we could develop a fast/reliable blood serum, saliva or hair, zinc test to assess zinc concentration (i.e., underlying conditions as well as survivability to viral infection)
Proposal: Compare Zinc test results of infected CV19 hospitalized patients who survive vs die vs “healthy?” (0.6-1.1mcgZn/ml).
Utilize Alkaline phosphatase enzyme zinc blood serum zinc test for better precision/accuracy
Develop MRI circuit for in vivo zinc plus developer (ligand/chelators ionophore- Zinc carrier molecule) . Administer zinc developer (injection or liquid/tab by mouth,)
Develop MRI office scanner – circuit board MRI not huge MRI – could eventually be implemented to a health wrist monitor.
Correlate these zinc blood tests to established standardized RNA/Antibody tests. The benefit being one zinc test result to assess infection, immunity, and survivability from CV19 and other coronaviruses.
Your thoughts on this proposal please.