15 Minute Point-Of-Care Rapid Antigen Test
ORAL RAPID ™ is an American Laboratory Validated Test
No Special Equipment or Lab Needed
Enhanced with Microsphere Coupling.
Made In America
ORAL RAPID ™ By Covid Antibody Diagnostics
The First Oral Antigen Test
The regulatory landscape for COVID19 testing is complicated and undergoing revision constantly. However, there are two pathways for regulatory approval and clearance of the ORAL RAPID ™ Rapid Antigen
Test. A. EUA
The main body governing diagnostic testing is the FDA under which laboratories are regulated by CLIA (the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments). During the current pandemic, the FDA authorized for Emergency Use (EUA) the initial RT-PCR test for COVID19 which remains the gold-standard for COVID19 diagnostics. They also implemented a process for laboratories and manufacturers to submit clinical performance documentation for EUA approval of other products or variations of existing laboratory protocols for COVID19 diagnosis.
Made In America
In an effort to reduce regulatory burden, on August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidance’s and other Food and Drug Administration (FDA) issuances concerning review of Laboratory Developed Tests (LDTs). HHS said FDA will not require premarket review of LDTs “absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances.” HHS added that those clinical laboratories seeking approval, clearance, or an emergency use authorization (EUA) for an LDT may still submit a premarket approval application/premarket notification/EUA request, but they are not required to do so.
The ORAL RAPID ™ test has undergone clinical validation in the high-complexity CLIA certified laboratory Applied Ingenuity Diagnostics and can be performed as an LDT by Applied Ingenuity Diagnostics. Our clinical validation data is provided below.
The ORAL RAPID ™ test is a lateral flow antigen test for the qualitative detection of the SARS-CoV2 nucleocapsid from either upper or lower respiratory
specimens (such as nasal, nasopharyngeal or oropharyngeal swabs, sputum, or aspirates collected from individuals suspected of COVID19 by a healthcare
provider. Testing is limited to Applied Ingenuity Diagnostics or other laboratories designated by Applied Ingenuity Diagnostics that are also certified under the CLIA regulations.
Results are for the identification of SARS-CoV-2 antigen. The SARS-CoV-2 antigen is
generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 virus; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Testing with the COVID19 ORAL RAPID ™ test is intended for use by trained clinical laboratory or medical personnel specifically instructed and trained in
the techniques of sample collection under medical or CLIA license. The ORAL RAPID ™ test is only for use under the CLIA LDT pathway by Applied
The ORAL RAPID ™ rapid antigen test kit is a lateral flow qualitative immunoassay for the rapid determination of the presence or absence of SARS-CoV-2 in human oropharyngeal specimens. The test kit comes with an oropharyngeal swab with 30 mm break-point, test cartridge, sample dilution buffer, mixing tube, and a package insert. The testing cartridge has two detection bands, including a distal control band that appears when the sample has flowed to the end of the testing strip. The presence of SARS-CoV-2 antigen are indicated by a red/purple line in the specific region indicated on the device
- Analytical Sensitivity
Limit of Detection Study
The LOD study established the lowest concentration of SARS-CoV2 virus that could be detected by the ORAL RAPID ™ test. The preliminary LoD was established by testing clinical samples for which genome copies (cp/ul) were established by RT-PCR. Replicates were tested for reproducibility.
The preliminary LOD was confirmed to be approximately 10000 copies/ul.
- Analytical Specificity
Cross-reactivity of the COVID19 ORAL RAPID ™ test was evaluated using testing clinical samples of whole organisms on the ORAL RAPID ™ test platform.
ORAL RAPID ™
- Clinical Evaluation
A contrived clinical study was performed to evaluate the performance of the ORAL RAPID ™ test. A total of 80 clinical respiratory samples were tested. Negative samples were negative by RT-PCR. Positive samples were chosen at 1X LoD or higher. Samples were in VTM. A nylon swab was placed into each sample and swirled for 15 seconds and then treated according the ORAL RAPID ™ protocol.
CDCEUA Positive (n=30)
CDCEUA Negative (n=50)
ORAL RAPID™ Positive
ORAL RAPID™ Negative
95% Confidence Interval
77 – 99%
The ORAL RAPID ™ test has similar if not better performance (based on published reports) to the Sofia antigen test. Applied Ingenuity Diagnostics has began to offer the test as a Laboratory Developed Test under the CLIA guidance for LDT performance. The test will need to be administered by a healthcare professional trained by Applied Ingenuity Diagnostics. Although results can be read onsite, they are not official until uploaded to our Test platform and validated by the Lab Director.
15 Min Point of care RAPID TEST
ORAL RAPID ™ Antigen Test
Oropharyngeal swab: clean the nasal cavity/oral cavity in advance, swab across the base of the tongue to the posterior pharyngeal wall, tonsil crypts, side walls, etc., wipe it repeatedly 3 to 5 times to collect mucosal cells.
Sputum or saliva: clean up the mouth, cough up sputum or spit out, and suck into the storage tube. The clinical effect of such samples may be lower than that of swab sampling.
Put the swab into the storage medium, the shaft of the swab should fully
immerse to the storage medium, break the flocked swab. Seal up the sample bottle.
A. Reagent preparation: Equilibriate the SPS tube to room temperature for at least 30 mins before testing swabs.
B. The head of the swab(s) should be completely immersed in the SPS.
Stir 3 to 5 times while pressing the head against the bottom and side of
the SPS bottle for l minute. Break the swab head into the Solution.
C. Place lid back on the SPS bottle while gently shaking the bottle 3 to 5 times
Made In America
Mouse monoclonal antibody preparation for Antigen Modeling
Twenty-four anti-N hybridoma cell lines, subtypes IgG1 and κ light chain, were prepared in large quantities by hybridoma cell suspension culture and mouse ascites.
High affinity antibody screening
React with 100ng/mL N protein, antibody titer is greater than 5 ng/mL.
Antibody epitope screening pairing
Preliminary identification of antibody recognition epitopes: E.coil recombinant expression of non-nucleic acid full N protein, nonnucleic acid N-N (1-210aa), non-nucleic acid N (211 ~ 419aa). Comparison of nucleic acid impact activity: E.coil recombinant expression of nucleic acid N protein, and 293F cells recombinan expression of N protein.
Screening and preparation of antibody combination N28/N40 that recognize the N-end and C-end of N protein and are less affected by nucleic acids.
With Rapid Antigen Studies, Nucleocapsid protein (N) plays a key role in the process of viru packaging, replication and protein translation. Protein N is considered a highly conserved sequence which has remained largely unchanged far back up the phylogenetic tree, and hence far back in the geological time scale.
Examples of highly conserved sequences include the RNA components of ribsomes present in all domains of life,
the homeobox sequences which are widespread among Eukaryotes, and the tmRNA in Bacteria.
North American Diagnostic’s Antigen Point of Care Test Kit’s accuracy for early detection is based on the conservative aspect of Virus sequencing whereby binding affinity for recognition of the N protein is pivotal for early detection of the virus.
The N protein contain large amount of Alkaline Phosphatase based protein, including NTD, CTD nucleic acid binding domains, and forms a dimer structure through the CTD region.
After binding the nucleic acid in nucleic acid binding domains of NTD and CTD, the antibody epitopes will be blocked and interfering with the recognition of N protein epitopes by antibodies.
Antigen Lateral Flow Immunoassay
Principle: Using 300 nm red carboxyl microspheres as a carrier, EDC/NHS is covalently coupled to two anti-N protein antibodies that recognize the N-terminal epitope, and the anti-N protein antibody (recognizing the C-terminal epitope) is used as the detection line.
Detection: The swab sample is to be pipetted carefully into the cassette well of the LFI device. Add 4 drops of the sample treatment solution.
Observe the color of the T/C line within 20 minutes.
For qualitative detection of SARS-CoV-2 virus antigen
nucleocapsid (N) protein i human nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum or saliva samples.
The entire test time is about 20 minutes, the shortest time is 10 minutes, the test results are interpreted as shown on the right.
Antigen Rapid LFI Kit components per box
Nitrocellulose membrane, mouse anti-N protein monoclonal antibody, goat anti-mouse antibody, tetrachloroauric acid
Reagent x 20
Colorless transparent plastic bottle dropper, containing sample antigen extract (PBS, Triton, NaDC)
Swab x 20
Multifunctional swab, artificial flocking of swab head, used for sampling of nasal cavity, nasopharynx and oropharynx.
Made In America
Point-of-Care Antigen Kit
1. Red microspheres (spherical microparticles)
Use of red microspheres to replace the color of colloidal gold improves the sensitivity of visual observation
> 10 times compared to the colloidal gold method
2. Double the amount of antibodies captures the N antigen
The self-made high-affinity double antibody (2 strains of N terminal monoclonal antibodies) is used to capture, thereby effectively improving the capture efficiency of antigen tracing. This results in an increase in the detection rate under point-of-care virus conditions;
3. C-terminal antibody color development
N-terminal monoclonal antibody and C-terminal monoclonal antibody detect N antigen in parallel, which significantly enhances the specificity of detection of new coronavirus;
4. High detection sensitivity
It reaches 10 pg/ml, which is close to the sensitivity of
chenmiluminescence method, which is 100 times that of
ordinary colloidal gold method;
5. High accuracy
Compared with PCR control, antigen reagents have 80%-90% positive coincidence rate and > 95% of consistency.
Covid-19 Antigen Testing: Analysis of Antigen Testing & The CDC
The world of COVID-19 involves a daily evolution of changes involving improvements of different types of Covid-19 testing. The CDC’s guidelines page provides critical information on licensing of laboratories, testing requirements, and collecting and handling of specimens.
Since the onset of Covid-19 in December 2019, antigen tests have been used widely to respond to the pandemic. There are CDC guidelines that laboratory professionals and clinicians who perform antigen tests, order antigen tests, receive the test results, and report on the test results. The analysis of antigen testing and the CDC guidance on the same will explore:
- The different types of SARS-COV-2 testing
- The Clinical Laboratory Improvement Amendments (CLIA) regulations on surveillance testing conducted by universities.
- The CLIA Enforcement on Centers for Medicare & Medicaid Services (CMS).
- The general guidance for rapid antigen testing for Covid-19.
The areas pointed out above will give you a clear picture of the CDC guidelines linked to antigen testing.
- Surveillance testing
- Covid-19 diagnostic testing
- Screening testing
- Universities and CLIA licensing
- Detailed CDC guidelines for rapid antigen testing for Covid-19
- Rapid antigen testing for different stages of infection
- Asymptomatic patients
- The general guide for Covid-19 antigen testing
Recommended CDC guidelines for the use and handling of Covid-19 antigen tests
- Surveillance testing
- Screening and diagnostic testing
- Rapid Covid-19 rapid test performance
- Handling of specimen
This Test has not been reviewed or cleared by the FDA. It is a Test Developed in a High Complexity CLIA Licensed Laboratory in the State of Florida, USA.