255 Primera Blvd., Lake Mary, FL 32746

(855) 752-6879

15 minute Point-Of-Care USA Antigen Rapid Test

Approval for Sale in 31 countries - 10/21/20

No Special Equipment or Lab Needed

Made In USA

Sensitivity  93.3%
Specificity  98.0%

Oral Test

Global Validations 
 USA 

Oral Rapid™ SARs-CoV-2 Antigen Rapid Test

1. Austria
2. Belgium
3. Bulgaria
4. Czech Republic
5. Cyprus
6. Denmark
7. Estonia
8. Finland

9. France
10. Germany
11. Greece
12. Hungary
13. Iceland
14. Ireland
15. Italy
16. Latvia

17. Lithuania
18. Liechtenstein
19. Luxembourg
20. Malta 
21. Norway
22. The Netherlands
23. Poland 
24. Portugal
25. Romania 
26. Slovakia 
27. Slovenia 
28. Spain
29. Sweden 
30. United Kingdom (Great Britain)
31. Croatia 

Please check back often since additional countries are being added weekly

Approved for sale 

 31 countries

No Special Equipment Or Laboratory Needed

Made In America

15  minute Rapid Test   

The First Oral Antigen Test 

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.

Intended Use

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 Ingenuity Diagnostics.

Device Description

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

 

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 Ingenuity Diagnostics.

Device Description

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

 Performance Evaluation

  1. 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.

  1. 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.

Organism

RT-PCR

COVID RTPCR

ORAL RAPID ™

Influenza B

Positive

Negative

Negative

Strep Pneumonia

Positive

Negative

Negative

E. Coli

Positive

Negative

Negative

K. Pneumoniae

Positive

Negative

Negative

Citrobacter

Positive

Negative

Negative

Human Rhinovirus

Positive

Negative

Negative

Coronavirus 229E

Positive

Negative

Negative

Mycoplasma Pneumoniae

Positive

Negative

Negative

       
  1. 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

28

1

ORAL RAPID™ Negative

2

49

Total

30

50

 

Statistic

Value

95% Confidence Interval

Sensitivity

93.3

77 – 99%

Specificity

98.0

89-99%

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 - Made in USA

Made In America

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

Detection card x 20
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.

USA Manufactured 

Point-of-Care Antigen Kit 

Data is transmitted by WIFI to the CDC or any other portal. At this time, we are under development with smart phone capabilities. 

iPeak is FDA listed, CE marked & ISO 13485 compliant

Our LFD Reader has BOTH Antigen & Antibody capabilities

Approved for sale in 31 countries

Sales Professionals

Call 855-752-6879