I have a niece Jodi (Medical Technologist and Lab Information Manager)who sent me a note on test kits.
Please forgive this long narrative but it may help people understand the delay in getting testing available. They use the term "kits" and it makes people think the COVID-19 testing is like a home pregnancy test or the little flu or strep test your doctor does in the exam room while you sit there. It is nothing even close.
It normally takes 3 years to get a test developed, vetted, approved by the FDA and mass produced enough to be available to an average lab for testing. 3 years!! This was done in 3 MONTHS! That means many things.
1. It is a very manual method. It isn't on a cute little analyzer or a home pregnancy kit. It requires A LOT of manual steps and detail.
2. Because it is a manual method, it needs a special "clean" environment (a BSL 3 or 4) lab space to do it in. Most hospital labs do not have even a BSL 3 certification and if they do, they are performing TB testing in it and it cannot be used for other testing. Cross contamination of the environment is a BIG problem. We also have to mention the safety of the technologist performing the test with the live virus.
3. Training of the personnel to run the manual testing. PCR extractions are very sensitive and if the person has been quickly trained and thrown into this testing, doesn't use the right technique and is rushing, the results can be flawed. "We have 14,000 more specimens when you are done with those 20!"
4. The sudden mass production of the necessary reagents and supplies to perform the test lends itself to a lower product standard level. (There was already a big problem with this in the beginning)
Even one of these variables would cause the FDA to not approve the testing. Add them all up and this is what we get and why the regular approval process takes so long.
The tests the other countries are using are NOT any better and have an even higher false positive and false negative rates.
The certified Medical Technologists and Clinical Laboratory Scientists are waiting on pins and needles for the FDA to release the big vendor's closed, SAFE, ACCURATE testing systems for our analyzers so we can start the large scale testing. BAD RESULTS ARE MORE DANGEROUS THAN NO RESULTS. We are here to save lives with accurate testing.