What information should be included in a consent form for the BTNX (Biotechnology Network Exchange) lateral assay COVID-19 (Coronavirus Disease 2019) & influenza A + B test, following current guidelines?

Consent Form for BTNX Lateral Assay COVID-19 & Influenza A + B Testing

A consent form for the BTNX lateral flow assay testing COVID-19 and influenza A/B must include comprehensive disclosure of test purpose, procedures, limitations, risks, and voluntary participation, with language accessible at appropriate reading levels and translated as needed for the patient population. 1

Essential Components of Informed Consent

Patient Information and Test Description

• Test name and purpose: Clearly state that the BTNX lateral flow assay simultaneously detects SARS-CoV-2 (COVID-19), influenza A virus, and influenza B virus from a single specimen 2
• Clinical indication: Document why testing is being performed (symptomatic presentation, exposure history, pre-procedural screening, or surveillance) 1, 3
• Specimen type: Specify that a nasopharyngeal, anterior nares, or midturbinate swab will be collected 1, 3

Procedure Details

• Collection method: Describe the swab collection process, including that the patient may experience brief discomfort during nasopharyngeal sampling 3
• Testing timeline: State that lateral flow assays provide results within 15-30 minutes at point-of-care 4, 2
• Personnel performing test: Identify that trained healthcare workers wearing appropriate PPE will conduct the test 3

Test Performance and Limitations

The consent form must explicitly state that lateral flow tests have reduced sensitivity compared to RT-PCR, particularly for Omicron variants and asymptomatic individuals, and that RT-PCR remains the gold standard for COVID-19 diagnosis. 3, 5

• Sensitivity ranges: Document that rapid antigen tests for SARS-CoV-2 show sensitivity of 95.1%-98.2%, influenza A 88.9%-95.2%, and influenza B 91.7%-100%, with specificity of 100% for all targets 2
• False negative risk: Explain that negative results do not completely rule out infection, especially in symptomatic patients or those with high clinical suspicion 1, 3
• Confirmatory testing: State that RT-PCR confirmation may be necessary for symptomatic patients with negative lateral flow results 3
• Co-infection detection: Note that the test can identify simultaneous COVID-19 and influenza infection, which occurs in 0.54%-2% of cases and may be associated with increased severity 6, 7, 8

Risks and Discomforts

• Physical discomfort: Brief nasal irritation, sneezing, watery eyes, or minor bleeding during swab collection 3
• Infection control risks: Minimal risk of COVID-19 transmission to healthcare workers when proper PPE protocols are followed 3
• Privacy considerations: Potential for confidentiality breaches, though de-identified data handling minimizes this risk 1

Benefits and Alternatives

• Direct benefits: Rapid diagnosis enabling timely treatment decisions, isolation guidance, and contact tracing 1, 3
• Public health benefits: Contributing to disease surveillance and pandemic control efforts 1
• Alternative testing: RT-PCR testing available with 6-8 hour turnaround (or as rapid as 45 minutes), offering superior sensitivity 3, 5
• Option to decline: Testing is voluntary and declining does not affect access to disaster aid or standard medical care 1

Results Management and Reporting

• Result notification: Specify how and when results will be communicated to the patient 3
• Documentation: State that results will be recorded in the electronic health record 3
• Public health reporting: Explain that positive COVID-19 results must be reported to local public health authorities per jurisdictional requirements 3
• Follow-up recommendations: Outline isolation protocols, treatment options, and when to seek additional care based on results 1, 3

Voluntary Participation and Withdrawal

The consent process must ensure voluntary decision-making without coercion, with explicit statement that participation does not affect receipt of medical care or disaster assistance. 1

• Right to refuse: Patient may decline testing without penalty 1
• Withdrawal option: Patient may withdraw consent at any point before specimen collection 1
• Re-consent considerations: For ongoing surveillance programs, periodic re-consent may be appropriate to maintain robust informed consent 1

Language and Accessibility Requirements

• Reading level: Written materials must be at appropriate literacy level for the patient population (typically 6th-8th grade) 1
• Translation: All study materials must be translated into languages anticipated in the patient cohort 1
• Oral communication: Written consent should be coupled with effective verbal explanation throughout the informed consent process 1
• Remote consent options: For pandemic safety or patient relocation, consider teleconferencing, videoconferencing, electronic signatures, or photographed signed documents 1

Documentation Requirements

• Competent decision-maker: Verify patient capacity to consent or identify legally authorized representative 1
• Adequate disclosure: Ensure all pertinent information has been provided 1
• Comprehension assessment: Confirm patient understanding through teach-back or questions 1
• Signature and date: Obtain written or electronic signature with date 1, 3
• Witness signature: Include healthcare provider signature confirming consent process 3

Special Considerations for Disaster/Pandemic Settings

• Sufficient time: Provide adequate opportunity for patients to consider participation despite transient nature of disaster settings (mass sheltering, relocation, long assistance lines) 1
• Physical distancing: Maintain infection control during consent process, using technology when appropriate 1
• Distinction from clinical care: Clearly explain difference between research testing and standard medical care if applicable 1
• Privacy protections: Address enhanced confidentiality concerns in disaster field settings, particularly when using local researchers or translators 1