On January 12, 2022, the Biden Administration announced that private health insurance plans will need to cover the costs of up to 8 test kits per month for each of their plan enrollees by their submitting receipts, or else directly provide the free test kits as an alternative. Schools will also give free test kits to teachers and school children so they can go to school safely.
Many in the Asian community have long learned that the rapid testing is not as effective as the PCR tests, and many would not purchase the rapid test kits to use out of their own pockets. The costs of the rapid test kits have been seen as a barrier to have more testing done. Starting on January 15, 2022, however, insurance companies will need to pay for eight test kits per person per month. Now that we can get free test kits, it remains to be seen if the community which has been skeptical about rapid testing will use them. Many people still have questions.
Questions related to the rapid tests
- What is the difference between a PCR test and a rapid test?
- Who can use rapid test kits?
- Where to buy the rapid test kits?
- Which brand should they buy?
- Do rapid test kits expire?
- Are additional supplies needed to conduct the rapid test at home?
- How to find out if the rapid test kits have received FDA’s EUA (Emergency Use Approval)?
- Can vaccinated people do the rapid test?
- Do the rapid tests detect omicron?
- Do the rapid tests detect past CoVID infections?
- When should rapid test kits be used?
- Should rapid test kits be used if no symptoms?
- How long should the wait period be between taking two self rapid tests?
- How to use the test kits?
- How to collect the specimen?
- Should we believe the test results?
- Will doing two tests at once improve the accuracy of the rapid test?
- If a positive test result is received, what should be done next?
- Should results be reported to the department of public health? If so, how?
- How to receive reimbursement for the test kits which they need to pay out-of-pockets first?
Answers to some of the above can be found in the following resource guides:
- CDC website: Click here or copy and paste in browser:
https://www.cdc.gov/coronavirus/2019-ncov/lab/point-of-care-testing.html - Harvard CoVID website: Click here or copy and paste in browser: https://www.health.harvard.edu/diseases-and-conditions/if-youve-been-exposed-to-the-coronavirus
Verification of the FDA approval status of the rapid tests
As of today, CDC has listed 18 rapid test kits (16 antigen tests, 2 molecular tests) that have received the EUA from the FDA, and 9 of the commonly used ones (antigen tests unless stated otherwise) are listed as below for your reference. More can be found at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2.
ADVAITE
- RapCovTM Rapid COVID-19 Test
Cepheid™
- Xpert® Xpress SARS-CoV-2
Abbott
- ID NOW™ COVID-19 test
- BinaxNOW™ COVID-19 Ag Card
Cue™ Health*
- CueTM COVID-19 Test (molecular)
Becton, Dickinson and Company (B.D.)
- Veritor™ System for Rapid Detection of SAR-CoV-2
LumiraDx
- LumiraDx SARS-CoV-2 Ag Test
Quidel
- QuickVue® SARS Antigen Test
- Sofia® 2 Flu + SARS Antigen FIA
California preventing price gouging of rapid test kits
In early January 2022, California Gov. Gavin Newsom’s office announced that he signed an executive order prevent price gouging on at-home COVID-19 test kits. The order prohibits sellers from hiking prices of the test kits by more than 10%.
San Francisco – Department of Public Health’s New Testing Order -1/12/2022
A friend told me that she was exposed to someone with symptoms and a confirmed positive Omicron infection. She was a member of a private health plan and went to the website to sign up for PCR testing on her own. The fastest opening for testing was 10 days later, and the test results would take 4-5 days due to the large volume of testing being conducted daily. Out of frustration, she went to get the testing done as a walk-in at one of the City’s sponsored testing sites. This obviously is not a one-person incident, but has happened to many people, and the City disproportionately bears the costs of testing.
Yesterday, the City announced orders for private healthcare institutions that they need to prove that they provide fast CoVID testing weekly or face heavy fines. More specifically, they need to provide appointments within 24 hours, and results within 48 hours, for 90% of their patients who have symptoms or are close contacts of such patients.
What masks to wear?
Fighting the CoVID pandemic has proven itself to be a dynamic process requiring changes to handle characteristics of variants. With the high transmissibility of Omicron and the variant’s ability to evade antibodies from vaccines and past CoVID infections, N95 or KN95 (the Chinese version of N95) masks, rather than cloth masks, can provide better filtration and protection. CDC is weighing recommending N95/KN95 masks as there is currently no shortages of these masks for healthcare professionals. Some states, such as Milwaukee and Connecticut, have started handing out free N95 masks in vaccination and testing sites, as well as public libraries and schools.
San Francisco’s schools most recent CoVID prevention guidance issued on 12/29/2021 does not require N95 masks. Any masks, including cloth masks, that do not have an exhalation valve can be worn. Masks are required for indoors but not outdoors for children >2 years old.
Some people, knowing that K95/KN95 masks which can filter out 95% of the virus but cannot afford them, has resorted to using double masking using two surgical masks or a surgical mask along with a cloth mask to increase the filtering capacity of masking, even though the City has not required double masking or using the N95 masks. Some people choose to wear different masks for different occasions, using N95 masks for perceived high-risk situations such as crowded places, and other masks for less risky situations.
There are no experiments to my knowledge regarding comparative effectiveness of different types of double masking vs. the N95 masks. But if there are no breathing problems doing double masking, there should be no harm in doing so. The fitted N95 masks have been the gold standard for healthcare professionals working directly with patients.
All masks need to fit snuggly on the face covering the nostrils and mouth, and that remains to be one of the most challenging tasks to achieve for most people.
Another important point to keep in mind is that if face masks get wet with moistures from breathing, it would be uncomfortable to wear them, and their filtering ability will also decrease. Disposable masks need to be changed and cloth masks need to be washed frequently. There are people who keep wearing the same (dirty) mask day in, day out to save money, defecting the purpose of wearing masks and compromising their safety in doing so.
San Francisco has enacted a new Order to control the spread of Omicron through universal masking for some indoor settings. The Order “suspends the indoor universal masking exemption for stable cohorts of 100% fully vaccinated people in select settings including workspaces, gyms, religious gatherings starting at 12:01 a.m. on December 30, 2021 until January 31, 2022.” As the Omicron continues to spike and hospitalization continues to increase for now, more stringent measures may be put in place to put the infection more in control.
Shortage of healthcare workers impacting CoVID care for patients
Despite clinical data showing that Omicron is causing a milder disease in most of the infected patients, it is still menacing to those who have high risks or the unvaccinated. With the high contagiousness of Omicron causing a vertical spike of new cases, hospitalization and death rates have increased across the nation in most areas. Many workplaces, including UCSF, have instituted vaccine mandates for employees to help them not become so sick even if infected.
Due to the shortage of workers, as well as new evidence showing that the incubation period (typically 3 days) for symptom onset for Omicron is shorter than the previous variants (4-5 days), CDC has put out new return-to-work protocols for those with a confirmed positive test, which has caused more confusions.
Mandatory vaccination-or-testing rule
Covid-19 testing was already a hot topic among employers due to OSHA’s mandate-or-testing rule for large private companies. This OSHA rule has been blocked by the Supreme Court (SC) just today, but the SC has partially allowed the rule to apply to medical facilities that take Medicare or Medicaid payments. News reported that the 6-3 votes from the 9 justices against the rule were pretty much in accordance with the conservative vs. liberal party lines.
According to a new survey of about 1,012 workers by business software and invoicing firm Skynova, most employees support their employers requiring proof of a Covid-19 vaccination. This survey found that 78% supported workplaces requiring proof of vaccination, with 12% not supporting it and 10% being unsure.
A separate, unrelated survey by the Kaiser Family Foundation in late October found that about 5% of unvaccinated adults left a job over the mandate.
Vaccination continues to protect us from getting seriously sick and help us to stay out of hospitals and avoid deaths. As antibodies wane over time after the second dose for both the Pfizer and Moderna vaccines, booster shots are highly necessary to increase antibodies to the previous effective level.
We are doing quite well in San Francisco. According to vaccine data in the San Francisco County, of the entire population, >90% has been vaccinated with 1 dose and 85% has completed the series as of 1/13/2022.
80-90% of the hospitalized patients due to CoVID are unvaccinated individuals.
The rate of CoVID infections found in children hospitalized with other medical conditions have doubled.
Summary – Prevention is still key
We are still having a huge CoVID surge worldwide, with a vertical spike of 860,744 new cases yesterday in the U.S. The actual number of new cases is much higher, as the asymptomatic or mild symptom cases usually do not get tested. Home testing will also contribute to higher numbers of unreported positive cases. Total number of counted CoVID cases in the U.S. is over 63.6 million, with over 844,000 deaths. California, with its large population, leads in the total number of CoVID confirmed cases and deaths.
The GISAID database yields the effective (instantaneous) reproduction number of Omicron – 3.19 (95% confidence interval [CI]: 2.82-3.61) times greater than that of Delta under the same epidemiological conditions.
Living with a highly contagious virus, prevention is still the key for us to return to a new normal. The bottom line, as Dr. Peter Chin-Hong has emphasized in the latest UCSF town hall, is that we need to use multiple modalities to prevent infection.
In summary, the following are the key strategies currently:
- Full vaccination
- Frequent testing
- Wear well-fitted masks
- Avoid mass or large gathering in areas with CoVID outbreaks
- Maintain social distancing
- Maintain good ventilation indoors
- Frequent hand washing