Consent Form for BTNX COVID-19, Influenza A + B Test
A comprehensive informed consent form for the BTNX lateral flow assay must include explicit disclosure of test purpose, specimen collection procedures, performance limitations (particularly reduced sensitivity compared to RT-PCR), risks of false negative results, voluntary participation rights, and result management processes, with all information presented at a 6th-8th grade reading level and translated as needed. 1
Essential Test Information and Clinical Indication
Document the specific clinical reason for testing, including whether the patient is symptomatic, has known exposure history, requires pre-procedural screening, or is part of surveillance protocols. 1
Specify the exact specimen type that will be collected (nasopharyngeal, anterior nares, or midturbinate swab) and explain the collection procedure to the patient. 1
State the test methodology clearly: The BTNX test is a rapid antigen lateral flow assay that detects SARS-CoV-2, Influenza A, and Influenza B antigens simultaneously. 2
Critical Performance Limitations That Must Be Disclosed
Explicitly state that rapid antigen tests have reduced sensitivity compared to RT-PCR, particularly for detecting Omicron variants and in asymptomatic individuals, and that RT-PCR remains the gold standard for COVID-19 diagnosis. 1
Document the specific sensitivity ranges: 95.1%-98.2% for SARS-CoV-2,88.9%-95.2% for Influenza A, and 91.7%-100% for Influenza B. 1
Explain the risk of false negative results in clear language, emphasizing that symptomatic patients or those with high clinical suspicion may still have infection despite a negative rapid test result. 1
State that confirmatory RT-PCR testing may be necessary for symptomatic patients with negative lateral flow results, with turnaround times of 6-8 hours or as rapid as 45 minutes depending on the laboratory. 1
Benefits and Clinical Utility
Direct patient benefits include: Rapid diagnosis enabling timely treatment decisions (particularly important for influenza antiviral therapy within 48 hours of symptom onset), appropriate isolation guidance to prevent transmission, and contact tracing initiation. 1
Public health benefits include: Contributing to disease surveillance systems and pandemic control efforts through mandatory reporting of positive COVID-19 results to local public health authorities. 1
Alternative Testing Options
RT-PCR testing should be presented as an alternative, explaining that it offers superior sensitivity and specificity (described as "very high" sensitivity and "very high" specificity by IDSA guidelines), though with longer turnaround times. 2, 1
Immunofluorescence testing (direct or indirect fluorescent antibody staining) represents another alternative with moderately high sensitivity and high specificity, with results available in 2-4 hours. 2
Results Management and Reporting Requirements
Specify exactly how and when results will be communicated to the patient (e.g., phone call, patient portal, in-person). 1
State that results will be documented in the electronic health record. 1
Explain mandatory public health reporting: Positive COVID-19 results must be reported to local public health authorities per jurisdictional requirements, which may involve sharing patient identifiable information. 1
Define decision limits clearly: Explain what constitutes positive, negative, and indeterminate results, and state the protocol for managing indeterminate results (typically repeat testing). 2
Voluntary Participation and Patient Rights
Include an explicit statement that testing is voluntary and that refusal to participate will not affect the patient's receipt of medical care or disaster assistance. 1
State clearly that patients have the right to refuse testing without penalty or negative consequences to their care. 1
Explain that patients may withdraw consent at any point before specimen collection without providing a reason. 1
Language and Accessibility Requirements
Ensure all written materials are at 6th-8th grade reading level to maximize comprehension across literacy levels. 1
Provide translations of all consent materials into languages anticipated in your patient population. 1
Use plain language explanations rather than medical jargon (e.g., "nose swab" rather than "nasopharyngeal specimen"). 1
Documentation and Verification Requirements
Verify patient capacity to consent or identify the legally authorized representative if the patient lacks decision-making capacity. 1
Ensure adequate disclosure of all pertinent information listed above has been provided. 1
Assess comprehension through teach-back method (ask patient to explain key points in their own words) or by asking specific questions about the test. 1
Obtain written or electronic signature with date from the patient or legally authorized representative. 1
Common Pitfalls to Avoid
Do not minimize the limitations of rapid antigen testing - patients must understand that negative results do not definitively rule out infection, particularly in symptomatic individuals. 1
Do not use technical terminology without explanation - terms like "sensitivity," "specificity," and "false negative" should be defined in plain language. 1
Do not assume patients understand public health reporting requirements - explicitly state that positive COVID-19 results will be shared with government health authorities. 1
Do not present the consent as a formality - ensure genuine informed decision-making by allowing time for questions and confirming understanding. 1