Search Results

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should therefore seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is an immunochromatographic assay that uses highly sensitive monoclonal antibodies to detect nucleoprotein antigens from SARS-CoV-2, influenza virus types A and B in anterior nasal swab (ANS) samples from symptomatic individuals. The test device is composed of a plastic housing, known as a cassette that contains a test strip with the following parts: sample pad, reaction membrane, and absorbing pad. The reagent pad contains colloidal gold conjugated with monoclonal antibodies (mAb) specific to SARS-CoV-2, Influenza A, and Influenza B target proteins. The reaction membrane contains different analyte specific antibodies to capture the target proteingold-mAb complexes at the respective test lines. Excess liquid and reagents are absorbed by the absorbing pad. The Healgen Rapid Check COVID-19/Flu A&B Antigen Test does not use biotin-Streptavidin/avidin chemistry in any of the steps for coupling reagents.

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is a qualitative lateral flow immunochromatographic assay intended for the detection and differentiation of influenza A, influenza B, and SARS-CoV-2 antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. The device is for non-prescription home use.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for clinical performance are based on Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a highly sensitive RT-PCR test. For usability, acceptance criteria are based on the accurate performance of critical and non-critical tasks during self-testing, and accurate interpretation of results.

2. Sample Sizes and Data Provenance for Test Set:

• Clinical Study (Test Set):
  • SARS-CoV-2: 1,097 evaluable subjects.
  • Flu A/B: 1,122 evaluable subjects.
  • Data Provenance: Multi-center, prospective clinical study conducted at ten clinical sites across the U.S. from February to April 2024. This is prospective, real-world data from symptomatic individuals.
• Usability Assessment (Test Set):
  • 51 subjects (26 self-collecting and testing; 25 lay users collecting and testing from another subject).
• Lay User Readability Assessment (Test Set):
  • All 51 subjects from the usability assessment participated. This involved interpreting a panel of 16 mock investigational tests.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

• Clinical Study: The ground truth for the clinical study was established using "highly sensitive RT-PCR tests separately detecting SARS-CoV-2 and Flu A/B." The document does not specify the number or qualifications of experts involved in running or interpreting these RT-PCR tests. However, RT-PCR is generally considered the gold standard and is performed by trained laboratory professionals.
• Usability/Readability Studies: For the usability and readability assessments, the "ground truth" for task performance and mock test interpretation was determined by the study design (i.e., what constituted a correct task or interpretation). The document does not mention external experts establishing ground truth for these aspects, as it primarily assesses user interaction and comprehension.

4. Adjudication Method for the Test Set:

• The document does not explicitly state an adjudication method for the clinical study's comparator (RT-PCR) results or for discrepancies between the candidate device and comparator. Given the direct comparison to RT-PCR as the ground truth, it implies the RT-PCR results were considered definitive for the clinical performance assessment.
• For the usability and readability studies, the "correctness" of tasks and interpretations was likely pre-defined and assessed by study staff based on the device's instructions, rather than requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• A MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not done. This device is a visually interpreted lateral flow immunoassay, and the AI component is not explicitly mentioned as directly linked to interpretation for human readers in a comparative effectiveness study setting. The study evaluated lay user performance in interpreting the test results directly.

6. Standalone Performance Study:

• Yes, a standalone performance study was done. The entire document describes the standalone performance of the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. This includes:
  • Analytical Performance: Precision, Cross-reactivity, Microbial Interference, Competitive Interference, Exogenous and Endogenous Interference, Limit of Detection (LoD), Co-spiked LoD, WHO International Standard comparison, High-dose Hook Effect, Inclusivity.
  • Clinical Performance: Comparison of the device results against RT-PCR (considered the ground truth) for SARS-CoV-2, Flu A, and Flu B.
  • Usability and Readability Assessment: Evaluation of lay users' ability to correctly perform the test and interpret results without external sophisticated aid.

7. Type of Ground Truth Used:

• Clinical Study: Highly sensitive RT-PCR tests for SARS-CoV-2, Influenza A, and Influenza B. This is a molecular diagnostic method generally considered the gold standard for viral detection.
• Analytical Studies: For analytical performance studies (e.g., LoD, cross-reactivity), the ground truth was established by known concentrations of purified viral analytes or specific microorganisms.
• Usability/Readability Studies: The ground truth for these studies was the pre-defined correct procedure or interpretation according to the device's Instructions For Use (IFU) and Quick Reference Instructions (QRI).

8. Sample Size for the Training Set:

• The document does not explicitly mention a "training set" in the context of a machine learning algorithm for the device itself.
• For the analytical performance studies (e.g., LoD, interference), various replicates (e.g., 3 replicates for preliminary LoD, 20-60 replicates for confirmatory LoD, 3 replicates for interference studies) were used to characterize the device's performance across different conditions. These could be considered analogous to data used to "train" or optimize the analytical aspects of the assay development, but not in the context of a machine learning training set.

9. How Ground Truth for Training Set Was Established:

• Not applicable in the context of a machine learning training set, as the device is a lateral flow immunoassay interpreted visually by humans.
• For the analytical characterization, the ground truth was established by precisely preparing samples with known concentrations of viral analytes or interfering substances at specified dilutions, often using quantitative methods (e.g., TCID50/mL, PFU/mL, CFU/mL).

Ask a specific question about this device