Getting much needed data on local COVID-19 cases to the people and professionals
We are offering this authenticated FDA-cleared medical device to gather DNA used for antibodies detection with no co-pay for insured patients (HR 6201)
*We are just the sample collectors leave the rest to MDs and pathologists, here's pictures and details on the device. This device is cleared for antibodies detection. It is most commonly used in neonatal care centers to screen babies for rare-genetic disease antibodies, today we are offering it for use in the crisis response; it's fast, gentle, and easy to administer:
Is this FDA approved?
The SARS-CoV-2 (COVID-19) assay in use at our sites has been issued Emergency Use Authorization by the FDA is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA has made high-complexity pathologic screenings available under an emergency access mechanism called an Emergency Use Authorization (EUA) under CLIA certification.
This genomic sampling assay offered by TestMe2.org has been validated for use prior to the emergency declaration on Coronavirus Disease because the laboratory meets high-complexity testing standards for the United States. It has been verified to detect even the smallest amount of Coronavirus antibodies titer. This collection method is currently in use for other applications by the FDA and has been approved by Medicare CMS in 2019 for the detection of other pathogens and bodily irritants.
TestMe2 is offering patients a blood-card genomic sampling SARS-CoV2 (COVID-19) IgE, IgM, IgG Antibody Assay. This high complexity pathologic screening assay has been issued Emergency Use Authorization by the FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). Our laboratory and screening method meet the strictest criteria for detecting SARS-CoV2 (COVD-19) IgE antibodies.
Citing FDA statement issued on February 29,2020 “Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff : Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under a CLIA certification (Clinical Laboratory Improvement Amendments) prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency” It is verified to be accurate at Coronavirus detections and authorized for use by the FDA during an emergency such as this pandemic.
What is High-Complexity Pathologic Screening?
TestMe2 testing sites are offering minimally invasive finger stick “blood-card” antibodies assay with high complexity genomic sampling for the discovery of SARS-CoV-2 IgE antibodies analyzed using high-speed robotics equipment in a protected CLIA Certified laboratory in California.
Blood-card genomic sampling is a cutting edge detection method created to take the pressure off of frontline workers and lab technicians by using high-speed robotics. Your small blood card sample is sealed on-site and delivered for analysis to Bay Area laboratory that's fully licensed and in good standing with quality standards (College of American Pathologists) the rigorous safety guidelines of CDPH-LFS (California Department of Public Health, Laboratory Fields Services)
The testing method has been used to accurately detect the activity of other viruses, pathogens, and harmful bodily irritants in the blood and is made available under an emergency access mechanism called an Emergency Use Authorization (EUA). A blood sample is collected via a blood draw from the patient’s finger tip and results are typically emailed by to the patient within 3 days.
What should I expect from the medical staff?
We take this responsibility very seriously. The blood-card assay is administered while in your car by the on-site medical staff. Once you drive in, you’ll be parked, then directed towards the medical site.
We do this to limit the amount of viral exposure, confirm patient identity, and just check in about your health if needed. Our staff prides itself on the best clinical policies, safe testing environment, and good door-side manner while offering this service to the community.
What do I need to do next?
Click here to pre-enroll before arriving at the site and select a location and time. Even if you feel healthy, it is important to know if you have been exposed to or potentially spreading Coronavirus. Typically a patient can expect to book, pre-enroll in about 15 minutes. then drive-in, verify their IDs and be ready within 5-10 minutes of arriving.
*We'll teach you the procedures for the test site during pre-enrollment, remember always remain in your car with windows up.
What is Pre-Enrollment?
Pre-enrollment establishes your medical needs and is monitored by our medical team remotely, it also gives the onsite medical staff knowledge of pre-existing conditions. You make your appointment, provide medical information while monitored by our medical staff on-line and the physician e-prescribes your screening. Pre-enrollment will save you 15-30 minutes per person off of your estimated drive in medical visit time.
Do you do a nasal swab test too, what is the difference?
The nasal swab test is for those who believe they may be currently infected with Coronavirus SARS-CoV2 (COVID-19) because they are experiencing symptoms or have been exposed to someone confirmed to have Coronavirus. Nasal swabs are only used If deemed medically necessary or indicated by on-site medical team.
You are within your rights to deny testing at or before the genomic sampling site, or opt for the high-complexity blood-card genomics assay instead of a nasal swab. Our drive-in medical testing site staff has great “door-side” manner.
The blood-card genomics sampling test is for those who are healthy, as well as have underlying conditions such as seasonal allergies or autoimmune conditions that want to find out if they are not infected or have previously been infected and recovered from SARS-CoV2 (COVID-19) or are battling it off currently.
How come I haven't heard of this, are you guys real?
Yes, We've been operational for several months in good standing with local health departments. Currently our only challenge now is getting the word out to communities and local organizations fast enough. We are here to help you and your loved ones at our site locations, just book an appointment and drive-in.
All blood-card genomic samples that have evidence of any Coronavirus infection are reviewed multiple times, so you can be assured your results will be accurate. The lab uses a high-speed robotics analysis method which has a faster run rate with much higher accuracy for SARS-CoV2 (COVID-19) Antibodies detection. They are also more durable and blood specimens break down slower than a nasal swab test resulting in better data for physicians, patients and public health departments.
We are just a genomic sampling site with medical staff, sending out samples to a CLIA certified laboratory to test for SARS-CoV-2 (COVID-19). Our physicians get you your results as soon as they're processed.
Where are the specimens processed?
Our testing centers merely act as specimen collection sites and results are given directly to our physician and medical team for follow-up. By using high-speed robotics our third-party lab partners can identify the smallest amount of Coronavirus activity accurately detectable while protecting reference lab workers and medical staff from potential exposure as much as possible.
Who will the test results be reported to?
All results will be reported daily to the health department in the patient’s county of residence, active infections will be reported within 1 hour of discovery.
Is TestMe2 operating under CA state law?
TestMe2 Sites are fully compliant, your screening is e-prescribed during pre-enrollment and the ordering physician licenses are on hand at the test site. All medical staff are operating in accordance to California state law.
If I was already tested by TestMe2, can I be retested?
TestMe2 has always administered valid tests. If you were previously tested by us you can remain confident in your results. If your situation has changed or you would like a different test, feel free to register online and come back. Private Pay-Pricing can be found on our website. We do not limit the number of times people can be tested.
How can else can I help other people?
We offer this service for employers with over 50 workers, government procurement departments, agencies and non-government organizations. If you know of a great site or community in need please contact the site hosting team here. We can accommodate the screening needs of senior care facilities and skilled nursing facilities in California.
Can’t I do this at my home?
During this pandemic, screenings covered by insurance with no co-pay need to be supervised by a medical professional at a drive-in testing site so please drive-in and keep your vehicle windows rolled up. You can arrange to pay for screening out of pocket if un-insured or want to do it in your home although it is not recommended due to higher costs and slower turn-around times with laboratory partners.
I pre-enrolled but didn't get screening, Is there a charge?
If you did not get tested, you did not get charged. We would never charge any patient if services were not rendered.
I want to bring others but they aren't able to pre-enroll?
Paper forms are generated on site for patients who do not pre-register but it is highly discouraged. Your pre-enrollment forms are printed and used on-site with photos to match the ones gathered during your pre-enrollment. A valid email/phone is required for getting results, multiple people can register under the same email or phone number if shared. We won’t turn you down, test sites are ADA accessible because you remain in the vehicle.
Do you allow screening of dogs, cats, or other animals?
No, only humans. We love pets, we know you see them as members of the family too. With the exception of service animals, we ask that they remain at home due to potential overheating in the car and interference to drive-in testing site procedures. If you are traveling with family members in the same car, we suggest everyone gets tested but please leave pets at home.
What if there’s a delay to get my results?
A SARS-CoV2 (COVID-19) infection must be reported within a maximum time period of 96hrs. If it takes longer than 4 days to get your results, we have not detected any activity of SARS-CoV2 (COVID-19) in your blood and there is no presence of infection at the time of testing. Sometimes our doctors are at capacity and it takes slightly longer to give the ancillary test results or do follow-ups on negative results, please keep that in mind.
I was at a site and they ran out of tests, what happens?
Only way to prevent that is always pre-enroll, we order supplies based on being at our full capacity. If there is one single time slot available on the site appointment page, we have supplied enough SARS-CoV2 (COVID-19) blood-card genomic sampling assays to accommodate up to 8 individuals for that timeslot. It is not uncommon for patients to see a site and visit us without pre-enrolling and be rescheduled, A valid ID, insurance card, and pre-enrollment forms are required before seeing the medical staff, we must turn down patients without these items and are able to submit your phone pictures as valid.
In the past, we have run out of supplies on several occasions so please book an appointment, pre-enroll inside the secure patient virtual waiting room so we ensure that we have enough supplies for you and your community.
Will my insurance cover SARS-CoV-2 (COVID-19) Ig/E Assay?
Screening is offered at no cost, covered by insurance. All insurances are accepted under HR 6201, IF you’re uninsured please register for the Affordable Care Act or any related federal healthcare programs before pre-enrolling with valid insurance information.
Is there a cost for a Coronavirus Screening?
WITH CURRENT INSURANCE, THERE IS NO CO-PAY FOR COVID-19 TESTING UNDER THE LAW HR 6201 INSURANCE MANDATES FOR SARS-COV2 (COVID-19). Please read the fine print below, we do not allow hidden or back billing from insurance disputes but only can protect against it with proof of valid insurance ID at site check-in.
*Specimens collected at TestMe2 are sent to a third-party lab for processing. These labs will bill the patients for their services. TestMe2 strongly encourages all patients to provide any insurance information so patients may be able to avoid being billed directly by our lab partners.
*Testing specimens collected at TestME2 are sent to third-party labs for processing. These labs will bill insurances for their services. TestME2 strongly encourages all patients to provide any insurance information to avoid being billed directly by our lab partners. We work directly with the lab that bills insurance and does not do hidden charges during insurance disputes (aka back billing). When testing for COVID-19 there is no-copay for tests or related telemedicine follow-up visits. Patients may receive a notice in the mail, this is NOT an invoice to pay. This is a receipt of testing and healthcare services, DO NOT MAKE ANY PAYMENTS TO THIS NOTICE, it is generated for your records in compliance with HIPAA (Health Insurance Portability and Accountability Act) Law. Your privacy is extremely important we never share your health information with a third-party except when required by law.