Search Results

The Healgen Rapid COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swabs specimens from individuals with signs and symptoms of upper respiratory infection within the first six (6) days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Healgen Rapid COVID-19 Antigen Test and followed with a molecular test
The test does not differentiate between SARS-CoV and SARS-CoV-2.
A negative test result is presumptive and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions.
Positive results do not rule out co-infection with other respiratory pathogens
Performance characteristics for SARS-CoV-2 were established from May 2022 to July 2022 when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.

The Healgen Rapid COVID-19 Antigen Test is a lateral flow immunochromatographic assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 virus in nasal swab collected specimens. The test strip is composed of the following components: sample pad, reagent pad, reaction membrane, and absorbing pad housed within a test cassette. The reagent pad contains colloidal-gold-conjugated monoclonal antibody that recognizes and binds to the nucleocapsid protein of SARS-CoV-2; the reaction membrane in the test line (T) contains the second antibody that recognizes another epitope of the nucleocapsid protein of SARS-CoV-2.
External quality controls are required but not included with the test kit and are sold separately as the COVID-19 Antigen Control Kit. The control swabs should be processed according to the Instructions for Use (IFU) and are intended to be used as quality control samples to demonstrate that the test is performing and is being performed correctly.

The provided text describes the performance characteristics and acceptance criteria for the Healgen Rapid COVID-19 Antigen Test.

Here's an analysis to extract the requested information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds in a table. Instead, it presents the results of various performance studies. The implicit acceptance criteria are that the device performance should be clinically acceptable and comparable to existing devices for substantial equivalence.

Here's a table summarizing the reported device performance, which can be interpreted as having met the (implicit) acceptance criteria:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: 806 evaluable subjects.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, and the virus strain mentioned is "USA-WA1/2020," suggesting a U.S. context.
  • Retrospective/Prospective: Prospective. The clinical performance study collected samples "prospectively collected from symptomatic subjects between May 2022 and July 2022 at six clinical point of care sites."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The ground truth for the clinical test set was established using RT-PCR assays, not expert human readers. Therefore, the concept of "number of experts" for ground truth establishment isn't applicable in the context of this device. The RT-PCR assays are considered the gold standard for detecting SARS-CoV-2 viral nucleic acid.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The adjudication method used for the comparator (RT-PCR) was a "2 out of 3 rules." This means that if the first two FDA-cleared, highly sensitive RT-PCR assays had discordant results, a third FDA-cleared RT-PCR comparator assay was performed, and the final result was determined by the majority.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a rapid antigen test read visually by users (healthcare professionals), not an AI-powered diagnostic imaging device that assists human readers. The study focuses on the diagnostic accuracy of the device itself compared to a molecular gold standard.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone "algorithm" in the sense of a chemical diagnostic assay that produces a visual result. There is no separate "algorithm" being evaluated without human-in-the-loop, as the human (healthcare professional) is part of reading the visually interpreted result. The "performance characteristics" section details the standalone performance of the device (the antigen test) against the RT-PCR comparator, which represents the device's accuracy without a separate human interpretation study impacting the core result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The type of ground truth used for the clinical performance test set was molecular SARS-CoV-2 assay results, specifically composite RT-PCR assays. This is a highly sensitive and specific laboratory-based "diagnostic truth" for the presence of the virus.

8. The sample size for the training set

The document does not mention a training set in the context of machine learning or AI models. This device is a lateral flow immunochromatographic assay, a chemical test, not a software or AI-based diagnostic tool that would typically involve a separate training phase with a distinct dataset. The "development" of such a test involves chemical formulation and design, not typically data training in the AI sense.

9. How the ground truth for the training set was established

As there is no mention of a training set for an AI/ML model, this question is not applicable to the Healgen Rapid COVID-19 Antigen Test.

Ask a specific question about this device