Search Results

The WELLlife™ COVID-19 / Influenza A&B Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of 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 nonprescription 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 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 seek follow-up care from their healthcare provider.

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

The WELLlife™ COVID-19 / Influenza A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of 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 use by individuals aged 14 years or older testing themselves, or adults testing 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 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 seek follow-up care from their healthcare providers.

Positive results do not rule out co-infection with other respiratory pathogens.

Test results should not be used as the sole basis for treatment management decisions.

The WELLlife™ COVID-19 / Influenza A&B Home Test and the WELLlife™ COVID-19 / Influenza A&B Antigen Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. The test has two versions, one for over the counter (OTC) use, the (WELLlife™ COVID-19 / Influenza A&B Home Test), and one for professional use (WELLlife™ COVID-19 / Influenza Antigen A&B). Both versions of the WELLIife™ COVID-19 / Influenza A&B Tests that have an identical general design and are intended for the qualitative detection of nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with respiratory signs and symptoms within the first four (4) days of symptom onset. Results are for the identification and differentiation of nucleocapsid protein antigen from SARS-CoV-2, nucleoprotein antigen from influenza A virus, and nucleoprotein antigen from influenza B virus. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with four lines: three test lines (Flu A line, Flu B line and CoV line) and a control line (C line). The device is for in vitro diagnostic use only. The device is for over-the-counter use.

The provided document describes the WELLlife COVID-19 / Influenza A&B Home Test and WELLlife COVID-19 / Influenza A&B Antigen Test. The following information is extracted regarding its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for molecular diagnostic devices like the WELLlife COVID-19 / Influenza A&B Home Test are typically established by the FDA and are generally expressed as minimum acceptable Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a reference molecular assay (e.g., PCR). While specific numerical acceptance criteria are not explicitly stated in this document (e.g., "PPA must be >X%"), the clinical performance results are presented, and the conclusion states that the device's performance demonstrates substantial equivalence to the predicate device. Therefore, the reported performance is presented against an implicit expectation of high agreement.

Note: The actual FDA acceptance criteria for PPA and NPA can vary based on test type, intended use, and public health context. The values listed under "Acceptance Criteria (Implicit)" represent typical expected ranges for such devices.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Clinical Performance Study: 787 enrolled subjects, with 705 evaluable subjects.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is from "Wondfo USA Co., Ltd." in San Diego, California, implying the study was likely conducted in the USA.
  • Retrospective or Prospective: Prospective study. Subjects were sequentially enrolled between December 2023 and March 2024, and samples were tested fresh.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The ground truth was established by an "FDA-cleared molecular comparator method," but details on the number or qualifications of experts involved in the molecular comparator testing, or explicit adjudication if necessary, are not mentioned.

4. Adjudication Method for the Test Set

This information is not explicitly provided. The document states that a healthcare professional collected a swab for testing using an "FDA-cleared molecular comparator method." The process for resolving discrepancies between the candidate device and the comparator method, or any other adjudication steps, is not detailed.

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

This document describes a diagnostic test for detecting viral antigens, not an AI-powered diagnostic imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance is not applicable and was not performed. The device is a lateral flow immunoassay interpreted visually.

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

The device is a lateral flow immunoassay that produces visible colored lines for interpretation. It is designed for "nonprescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older." While it's a "standalone" device in the sense that it doesn't require a separate instrument or a healthcare professional for interpretation at home, it does rely on human visual interpretation (human-in-the-loop). Therefore, a "standalone algorithm only" performance is not applicable as there is no underlying algorithm in this context.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the clinical performance study was established using an "FDA-cleared molecular comparator method" (e.g., PCR).

8. The Sample Size for the Training Set

This document does not specify a separate "training set" in the context of machine learning. The non-clinical performance studies (Lot-to-Lot Precision, Limit of Detection, Inclusivity, Analytical Specificity) used various contrived and spiked samples. The clinical study used 705 evaluable subjects. For a lateral flow immunoassay, "training" typically refers to the development and optimization process involving chemical formulations, antibody selection, and manufacturing parameters, rather than a distinct data training set for a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

As noted above, a distinct "training set" in the machine learning sense is not described. For the analytical studies, ground truth (e.g., viral concentration, presence/absence of interferents) was established by spiking samples with known concentrations of viruses or other substances. For the clinical study, the reference standard was the result from an FDA-cleared molecular comparator method.

Ask a specific question about this device