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First Antigen Rapid Test Revealing 100% Sensitivity Conducted Double Blind With Asymptomatic Patients

Our Oral Rapid Antigen kit is the only Rapid Test in the World which possesses an RT-PCR test option utilizing our ONE-Swab-ONE-Tube testing system.

United States - April 11, 2021 /MarketersMedia/ —

On-Demand confirmation reference testing with RT-PCR just became easier anywhere in the WORLD.

Oropharyngeal Collection

Statistical Analysis of Oral Rapid vs RT-PCR
True Positives 36 True Negative 33
False Negatives 0 False positive 3
Sensitivity 100% Specificity 92%

The reliability of the Oral Rapid test has been analyzed in a true double-blind manner. This approach has not been undertaken by any manufacturer in the world until now. This study conducted by James Chao, MD – California of Spectrum Labs in conjunction with SDI Labs Inc. showed performance of 100.0% sensitivity and 92.0% specificity at a Ct count of 30.9 and below. Ct counts are the number of times a PCR instrument must cycle through to amplify enough genetic material of the SARS CoV-2 virus for it to be detectable. The greater the amount of virus present (viral load), the fewer cycles required to detect the virus. A person with a higher viral load (and lower Ct count) is more likely to be infectious.

Purpose

Retrospective OP swabs collected by a health care professional were tested in a double blinded study with the Oral Antigen device and compared to the RT-PCR results. CT values of RT-PCR on Nasopharyngeal samples was used as the gold standard control to compare the samples tested on the Oral Rapid device sample.

Study setup

In this study NP swab samples were collected in a proprietary buffer at the clinical site following HIPAA regulations by a health care professional. Oropharyngeal samples were also collected from the same individual.

The purpose of this test is to a). determine the sensitivity and specificity of the Oral Rapid kit

Thirty-six each of PCR positive and PCR negative patient samples selected at random in a double blinded manner where the CT value of the sample or the demographics of the subject was not consulted when selecting the samples. To perform the Oral Rapid, the OP swab sample in VTM was mixed and 3 drops of the sample were added to the sample well of the Oral Antigen Lateral Flow device as indicated in the product manual. The Oral Rapid device color development of the control line [C] and the test line [T] were noted after 15 minutes at room temperature. Pictures were taken of all samples tested with ORA device (Figure 2).

RT-qPCR was performed with the EUA certified BioRadTM COVID-19 assay.

Evaluation

A total of seventy-two clinical samples (thirty-six positive and thirty-six negative were tested. Of the thirty-six positive samples, 13 were symptomatic and 23 were asymptomatic and thirty-six negative samples as determined by RT-qPCR. The Oral Antigen test kit data was compared to the RT-qPCR data after the test was performed. No false negative and 3 false positive samples were detected in the 72 samples by Oral Rapid device.

Summary

We tested 72 double blinded retrospective clinical samples were 13 symptomatic positives, 23 asymptomatic positives and 36 negatives as determined by RT-PCR of the NP samples collected from the same patients at the time of collecting OP samples. The samples were stored at 4C for up to three months to evaluate the specificity of the device i.e., detection of false positives and sensitivity of the device i.e., detection of false negatives. This is a true differentiator from many antigen kits on market that have high rate of false positives due to non-specific interactions with the sample or other contaminants present in the sample.

Three-month-old samples gave excellent detection of the test antigen [T] in all thirty size positive samples with RT-PCR CT values ranges from 15 CT to 31 CT giving a sensitivity of 100%.

Three false positives were detected in the eighteen RT-PCR negative samples tested giving a specificity of 92%. This was resolved by a lower volume of sample. This is also indicated by the residual background pink streaks in the device with the first batch of 36 patients. The slight background in the “T” band was eliminated by adding lower volume of the sample.

RT-PCR CT values for the NP clinical samples and corresponding Oral Rapid device (cassette) reading. Three genes of SARS-CoV-2 are targeted by the BioRad COVID-19 assay, RdRp, N gene and E gene. The CT values for the RdRp gene and the N gene are reported for the positive (Table 2A) and negative (Table 2B). Average CT values ranged from 15.3 to 30.9 in the randomized samples selected for performing the antigen test. No false negatives were detected. 3 false positives were detected.

Pictures of the Oral Rapid test for all 72 samples were taken. Three drops of OP sample were added to the Sample well of Oral Rapid cassette. The test was timed for 15 minutes and the pictures were taken and uploaded of the test cassettes.

North American Diagnostics is a global leader in developing, manufacturing, and distributing diagnostic testing for infectious diseases and fertility Lateral flow assays. NAD has collaborated with leading Hospitals and high complexity laboratories to develop its COVID-19 test lines.

Headquartered in Daytona Beach, Florida, North American Diagnostics is a worldwide leader in developing cost-effective point-of-care rapid tests. The company currently employs 100 people at its Daytona research and development facility.

For additional information, please contact: info@NorthAmericanDiagnostics.com

For press inquiries, please contact Paul Singh at Paul@NorthAmericanDiagnostics.com.

SOURCE North American Diagnostics, LLC.

Contact Info:
Name: Paul Singh
Email: Send Email
Organization: North American Diagnostics
Address: 618 Ridgewood Ave, Daytona Beach, FL 32117
Website: http://www.NorthAmericanDiagnostics.com

Source URL: https://marketersmedia.com/first-antigen-rapid-test-revealing-100-sensitivity-conducted-double-blind-with-asymptomatic-patients/89004576

Source: MarketersMedia

Release ID: 89004576

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