A fast(er) multiplex test is coming:
Should get a few birds with one stone: Flu, RSV, and SARS-CoV 2 , and only one swab.
More on Kittyvir:
https://www.businessinsider.com/coronavirus-treatment-cats-fip-sold-10k-black-market-2020-6
This study was evaluated in great detail the other day by Dr. Chris Martenson (PhD in Pathology) on his CV 19 updates YouTube channel. Heâs been covering CV 19 since early January and raised the alarm early on about what was happening in Wuhan and that this could become a global pandemic. Hereâs the condensed version below.
The good: randomized, double-blind, placebo controlled (folate), started treatment as early as was possible from start of self-reported symptoms (within 4 days).
The limitations: recruited online mainly through social media (young, median age of 40), all data self-reported online (no doctors seen to verify symptoms or adherence), the biggest limitation - less than 3% of participants were actually tested to verify if they had CV 19 or not.
From the Discussion section of the study above:
ââŠgiven the small number of PCR tests, it remains theoretically possible that hydroxychloroquine therapy limits proven infection.â
Good to see this acknowledgment given such a huge limitation of actual CV 19 testing in the majority of the study participants.
âThe dosing regimen for hydroxychloroquine was 800 mg (4 tablets) once, then 600 mg (3 tablets) 6 to 8 hours later, then 600 mg (3 tablets) daily for 4 more days for a total course of 5 days (19 tablets total).â
âTwo hospitalizations were reported (one in each group). No arrhythmias or deaths occurred.â
What I found interesting is that even with such high dosing of HCQ, well above whatâs normally recommended for use in CV 19, no arrhythmias or deaths occurred. After the first day taking 1400 mg of HCQ within 6 to 8 hours! and if they experienced GI side effects, I wonder how many stopped taking the medicine but reported they were still adhering to the study?
Nothing in the release on accuracy.
Apparently this machine is already at many doctors offices. Wonder if this will be used at colleges.
âOur largest GeneXpert System is configured with up to 80 modules â meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day*.â
They canât say anything about the accuracy of the test until it gets the FDA green light. This co were not the first to market their Covid test because they wanted to get it right before releasing it (per some earlier interviews of the CTO quoted in this link), and their test has proven to be quite accurate. We will know the data soon. The test datasheets are posted on their website.
The 2,000 number is likely to be more like 1,000 under real, busy central lab conditions, but it is still quite impressive. Plus, from what I understand, the modular design allows the large system to run any combination of GX cartridges at the time (flu, MRSA, HPV, etc.). Just scan the cartridge and stick in in the queue. The machine will figure out what PCR program to run and will spit out the results.
This makes me very happy! Hopefully colleges will be getting these. Crossing fingers for FDA approval and good accuracy.
I wish there was more (good) medical news on the Covid front. This thread is quietâŠ
For a college or any other entity to run a test, the test needs to be truly POC, CLIA-waived (not just under EUA); otherwise, it has to be run in a CLIA-certified lab (meaning a medical facility). The FDA has been very slow to allow such tests in the past⊠maybe this will give a needed push. Plus there is the issue with sample collection. As long as the nasal swab method is used, it will require lots of PPE. Need a better sample collection method.
A while back I remember reading a blurb about a saliva test. Is this even in development, or is it actually a âwouldnât it be greatâ kind of thing?
Yes! Wasnât some group doing the saliva tests on the West Coast?
Large-scale testing would be boosted immensely if there such a test (or the breathalyzer-type test).
Yes, Rutgers came up with the test. I havenât heard a followup. Could be there is a reliability issue. The easier a test is, the less reliable it seems.
For the purpose of reducing the spread of the virus, a breath test may be helpful in testing for contagiousness (which is different from infection).
If its cheap and easy, it would be fantastic. It canât come soon enough.
All Iâve heard (post phone call) is that the same Covid doctors and health care workers who were optimistic about reopening if it were done safely because they know more and have more equipment than before are now concerned and have a few choice names + a swear word or two for some of the population out there.
So far there isnât a current problem. Time will tell if there will be one or not.
@BunsenBurner from the FDA website
: Q: When FDA authorizes under an EUA a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived? (Updated 5/9)
A: Yes. The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA authorizes tests for use at the point of care (including SARS-CoV-2 point of care test systems) under an EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Most medical centers have a certificate of accreditation , many college health centers have a waived certificate . You are correct about the PPE.
@Mabelsmom - yes, the key word is POC. âPoint of careâ. Must be a clinic or a lab that is CLIA-waved and still requires swabbing and qualified medical personnel to run the tests. Having the test at the Point of care means a hospital, clinic, etc. does not have to send the samples to a central lab. Not necessarily a test that is currently authorized to be run in an airport or college admissions office or such. So for colleges this would mean the college clinic or health center.
I am well aware of what POC means. You comment that an EAU test could not be done at a college was incorrect. College medical center/ clinics have Clia certification ( waived) so could do the test . Most college health center clinical employees are already trained to do NP and throat swabs for other test including mono, and MRSA. They would need access to PPE.
Dr Brix talked about a test like a pregnancy test. Easy to administer. I think accuracy is the stumbling block for now.
Sorry to late to correct, I meant strep. , not mono In my previous o post.