Policy and Procedure Manual for BTNX COVID-19 & Influenza A/B Lateral Flow Test
Pre-Testing Patient Screening and Preparation
All patients and staff must undergo systematic screening before entering the testing area to minimize COVID-19 transmission risk. 1
Patient Screening Protocol
- Screen patients by phone prior to appointment for COVID-19 symptoms including fever, cough, difficulty breathing, and unusual fatigue 1
- Re-screen patients upon arrival with the same symptom checklist 1
- Perform temperature screening at facility entrance (threshold >37.5°C) 1
- Document all screening results in patient records 1
- If patient screens positive for symptoms, provide mask immediately and follow local infection control protocols 1
Spatial and Scheduling Considerations
- Maintain 6 feet (2 meters) physical distancing in all waiting areas 1
- Minimize non-essential visitors and limit patients to one caregiver maximum 1
- Schedule one examination at a time to prevent crowding 1
- Separate testing areas from administrative areas when possible 1
Healthcare Worker Protection Requirements
All testing personnel must wear appropriate personal protective equipment (PPE) throughout the testing procedure. 1
Mandatory PPE for Testing Staff
- Surgical mask or FFP2/FFP3 respirator (N95 equivalent) 1
- Eye protection (goggles or face shield) 1
- Disposable gloves (changed between each patient) 1
- Gown when performing tests on suspected or confirmed COVID-19 cases 1
Staff Safety Protocols
- Record staff temperature and symptoms at start of each shift 1
- Maintain strict hand hygiene before and after each patient encounter 1
- Test symptomatic healthcare workers immediately and exclude from work until negative result obtained 1
- Minimize number of staff in contact with each patient 1
Testing Procedure for BTNX Lateral Flow Device
The lateral flow test should be performed following manufacturer instructions with strict infection control measures. 2, 3
Sample Collection
- Use nasopharyngeal swab for optimal sensitivity, as this is the standard specimen type for SARS-CoV-2 detection 1, 4
- Collect sample while wearing full PPE as outlined above 1
- Patient should wear mask during collection, removing only when necessary for swab insertion 1
- Avoid aerosolization during sample collection 1
Test Performance
- Process one test at a time in designated testing area 1
- Follow BTNX manufacturer instructions for sample processing and timing 2, 3
- Read results at specified time interval (typically 15-20 minutes for lateral flow devices) 2, 3
- Document results immediately in patient record 1
Result Interpretation
- Positive result indicates presence of SARS-CoV-2 antigen or influenza antigen depending on test line 2, 3
- Negative result does not definitively rule out infection, particularly in asymptomatic individuals or those with low viral loads 5
- Invalid results require repeat testing with new device 2, 3
Equipment and Environmental Management
All surfaces and equipment must be thoroughly cleaned between each patient to prevent cross-contamination. 1
Between-Patient Cleaning Protocol
- Remove and discard all single-use materials immediately after test completion 1
- Clean all surfaces contacted by patient or staff with EPA-approved disinfectant or 70% isopropyl alcohol 1
- Disinfect keyboards, doorknobs, table surfaces, and all frequently touched areas 1
- Allow minimum 5 minutes between patients for cleaning and air exchange 1
Room Ventilation Requirements
- Keep testing room doors closed during procedures 1
- Open windows for 15-30 minutes between patients if natural ventilation available 1
- For confirmed COVID-19 cases, close room for 30-60 minutes after testing before terminal cleaning 1
- Use negative pressure rooms for suspected or confirmed COVID-19 cases when available 1
Waste Disposal
- Dispose of all used test devices, swabs, and PPE as infectious medical waste per local regulations 1
- Use sealed biohazard containers for contaminated materials 1
- Remove waste from testing area promptly after each session 1
Test Limitations and Clinical Considerations
Lateral flow tests have reduced sensitivity compared to RT-PCR, particularly for Omicron variants and in asymptomatic individuals. 5
Known Performance Limitations
- Sensitivity decreases significantly when viral load is low (PCR cycle threshold >25) 5
- Performance may be reduced for Omicron variants compared to earlier strains 5
- Asymptomatic individuals may have false-negative results despite being infectious 5, 6
- Negative lateral flow test does not exclude COVID-19 diagnosis 5
When to Confirm with RT-PCR
- RT-PCR remains the gold standard for COVID-19 diagnosis with superior sensitivity and specificity 1, 4
- Consider confirmatory RT-PCR for symptomatic patients with negative lateral flow results 5
- RT-PCR confirmation recommended before high-risk procedures or for immunocompromised patients 1
- PCR turnaround time is typically 6-8 hours but can be as rapid as 45 minutes 1, 4
Documentation and Reporting
All test results must be documented and reported according to local public health requirements. 1
Required Documentation
- Patient demographics and contact information 1
- Screening questionnaire responses 1
- Temperature reading if obtained 1
- Test lot number and expiration date 2
- Time of sample collection and result reading 2
- Test result (positive/negative/invalid) 2
- Staff member performing test 1
Reporting Obligations
- Report positive results to local public health authorities per jurisdictional requirements 1
- Notify patient of results promptly 1
- Provide isolation instructions for positive cases 6
- Document all results in electronic health record system 1
Quality Control and Training
Staff must receive proper training on test performance and infection control procedures before conducting testing. 1
Staff Training Requirements
- Training in local infection control recommendations 1
- Proper PPE donning and doffing technique 1
- Correct sample collection technique 4
- Manufacturer-specific device operation 2, 3
- Result interpretation and documentation 2, 3