Covid-19 Antigen
Rapid Home Test
Contract manufacturing of up to 1,500,000 test kits per week with about 3 week lead time
Clinical Study
New York City, 2023
Clinical Trial: Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
Our clinical study has been completed this past year and attained 87.1% sensitivity in a study of over 170 participants.
Clinical Trial: Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
Enrolled 172 participants, in Queens New York Walk-in Clinic center.
RT-PCR was used as Comparator
HIPPA Compliant Clinical Trial Researchers
Symptomatic and asymptomatic patients
Clinical Trial Data
High Specificity 97.7%
The assay showed > 97.7% specificity for specimens from 160 patient nasal swab donors for SARS-CoV-2. Specificity is proportion of samples that are genuinely negative that give a negative result using the test. People who do not have the target disease will test negative.
No Cross Reactivity
The assay showed no cross-reactivity to four of the most common coronaviruses, along with Influenza A, B, Parainfluenza, Chlamydia pneumonia, Mycoplasma pneumoniae, Respiratory Syncytial virus, HIV, CMV, Mumps virus
High Sensitivity 87.1% < 7days
The assay achieved 87.1% sensitivity for patients tested ≤ 7 days after onset of symptoms between ages of 18-70 years of age. A total of 160 patients were tested. Sensitivity is the proportion of samples that tests truly positive using the test. People who have the target disease will test positive.
Swab
Gently insert swab into lower nostril and rotate three times. Do this with other nostril
Mix
Dip the swab into tube and rotate 5 times. Insert cap into tube
Test
Pour few drops into cassette
15 min
Results ready in just 15
Results
If positive, 2 lines will appear. You can perform an additional test the next day to confirm
Results
If positive, 2 lines will appear. You can perform an additional test the next day to confirm
Who We Are
Founded in 2021, Testing Done Simple consists of a team of experts in statistics, infectious disease, medicine, and marketing who collectively work as team to bring you affordable, safe, and high quality diagnostic testing. We are an American based company that believes in empowering people to take charge of their own health. Our business partner, AIVD Biotech, will be manufacturing the actual test kit and have many years of experience and expertise in this area.
Manufactured by
AIVD Biotech Manufacturer
R&D laboratory, complete biochemical, immune, and molecular diagnostic product lines
FDA Compliant, GMP certified facility, and ISO certified facility - ISO 9001 & ISO 13485
Professional registration team with many years of registration inspection experience
Production license of Class II and Class III in vitro diagnostic reagents
Detects Omicron and Delta variants
FAQs
The test kit was evaluated for performance separately by the manufacturer and us, the distributor. The manufacturer obtained a 95% sensitivity in their study. In our own American clinical trial, we confirmed their findings with a 87% sensitivity in a study of 170 patients. The test kit was shown to be safe in our clinical trial as there were no reported side effects or adverse events.
We only sell bulk amounts. By doing so, this will ensure that you obtain the most cost savings.
At the present time, you must be a currently employed governmental official from either a governmental health agency, governmental health department, or governmental ministry of health. We also accept orders from government officials that have the authority to order test kits on behalf of their citizens.
We can print the box in any language requested. We can add any phrasing or text on the sides as needed.
We provide affordable and high quality testing that has been scientifically validated several times. Because we are a small company with less overhead expenditures, this allows us to charge less than other larger companies
A PCR test checks for viral RNA and usually takes 1-2 days to obtain results as more sophisticated laboratory equipment and technicians are required. Our test checks for viral proteins and produces results in 15 minutes without the need of special equipment.
Yes. We offer bulk production, assembly, and packaging of test kits. Turnaround times of about 2-3 weeks.
Although the Covid pandemic is not as widespread and severe as it originally was, there are still ongoing cases. As Covid-19 produces similar symptoms to Cold/Flu, there may be a need to get Covid testing as a form of routine and preventative care at least for sometime.
All plans to make it available in USA have been postponed for now due to complex medical device regulations. We may pursue this at a later time.
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- Testing Done Simple
- 8 The Green Suite 13458 Dover, DE 19901 USA
- 1-888-714-3114