COVID-19 At-Home Test: Healthcare Provider Instructions for Use
Introduction and Authorization
This document provides instructions for use for the COVID-19 At-Home Test, distributed by Roche. It is intended for Healthcare Providers.
Authorization: For In Vitro Diagnostic Use. For use under an FDA Emergency Use Authorization (EUA) only. For use with anterior nasal swab specimens.
For more information on EUAs, visit: FDA EUA Information.
For the most up-to-date information on COVID-19, visit: cdc.gov/COVID19.
Intended Use
The COVID-19 At-Home Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen.
- Non-prescription home use:
- Self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 6 days of symptom onset.
- Adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 6 days of symptom onset.
- Self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19. Testing should be performed twice over three days with at least 24 hours (and no more than 48 hours) between tests.
The test does not differentiate between SARS-CoV and SARS-CoV-2.
Result Interpretation: Positive results indicate the presence of viral antigens. Clinical correlation with patient history and other diagnostic information is necessary. Positive results do not rule out bacterial infection or co-infection with other viruses. Individuals testing positive should self-isolate and seek follow-up care. Negative results are presumptive and may require confirmation with a molecular assay. Negative results do not rule out SARS-CoV-2 infection and should not be the sole basis for treatment or infection control decisions. Consider recent exposures, history, and clinical signs. Serial testing may require confirmatory molecular tests for both positive and negative results, especially in high-prevalence settings or if symptoms persist.
Individuals who test negative but continue to experience COVID-19-like symptoms should seek follow-up care. All results should be reported to a healthcare provider for public health reporting.
Principle of the Test
The test utilizes a nitrocellulose membrane with pre-coated lines: a "C" Control line and a "T" Test line. Mouse monoclonal anti-SARS-CoV-2 antibody is coated on the test line region, and mouse monoclonal anti-Chicken IgY antibody is coated on the control line region. A conjugated antibody acts as a detector. When a sample containing SARS-CoV-2 antigen is applied, it forms a complex with the conjugated antibody. This complex migrates to the test line, where it is captured by the anti-SARS-CoV-2 antibody, resulting in a visible colored test line.
Reagents
- mAb anti-COVID-19 antibody
- mAb anti-chicken-IgY
- mAb anti-COVID-19 antibody-gold conjugate
- Purified chicken-IgY-gold conjugate
Materials Provided
- Test device: A small rectangular device with labeled areas "C" and "T".
- Tube with liquid: A plastic tube containing a clear liquid reagent.
- Nozzle cap: A cap for the reagent tube.
- Sterile swab: A swab with a foam tip.
- Tube holder: A plastic stand for the reagent tube.
- Quick Reference Instructions: A folded leaflet with visual guides.
Available in 1-test (09620702160), 4-test (09666672160), or 25-test (09620729160) quantities.
Materials Required (Not Provided)
- Timer
Warnings and Precautions
- This product is authorized by FDA under an EUA; it is not FDA cleared or approved.
- Authorization is for the detection of SARS-CoV-2 proteins only.
- Authorization is for the duration of the declaration justifying emergency use.
- Follow directions for use.
- Use the test kit once only. Do not use with multiple specimens.
- The test aids in diagnosing current SARS-CoV-2 infection; consult a healthcare professional for results and further testing.
- Keep test kit and materials out of reach of children and pets. Seek medical advice if ingested.
- Children below 14 should be swabbed by an adult.
- Wear a face mask if swabbing others.
- Do not use on anyone under two years of age.
- Do not open kit contents until ready for use.
- Do not use after the expiry date.
- Do not use if the pouch is damaged or open.
- Ensure sufficient light when testing.
- Visual reading only; users with impaired vision may have difficulty.
- Do not use nasal sprays for at least 30 minutes before sample collection.
- Clean spills with a suitable disinfectant.
- Use only kit components.
- If blood is present on the swab, discard, ensure bleeding has stopped, and repeat with a fresh swab.
- Remove nasal piercings before testing.
- Control line may appear within minutes; test line may take up to 20 minutes.
- Do not use on individuals prone to nosebleeds or with recent facial/head injuries/surgery.
- Inadequate sample collection may yield false negative results.
- Do not touch the soft pad of the swab.
- Read test at 20 minutes; reading before 20 or after 30 minutes may cause inaccurate results.
- Do not ingest kit components.
- Avoid contact of extraction tube solution with skin, eyes, nose, or mouth.
- Reagent solution chemicals may be hazardous; consult table for safety. No PPE is currently recommended.
Chemical Hazards
| Chemical Name/CAS | Hazard Category (mixture) | Hazard Statement for Mixture | Labeling of Harm(s) |
|---|---|---|---|
| Sodium chloride / L-Arginine | Category 2 | Eye irritation | May cause eye irritation |
| Polidocanol / ProClin® 300 | Category 3 | Skin irritation | Causes mild skin irritation |
If reagent solution contacts skin or eye, flush with water. Seek medical advice if irritation persists (poison.org or 1-800-222-1222).
Limitations
- Not for use on individuals under 2 years of age.
- Children aged 2-13 should be tested by an adult.
- Higher chance of false negative results with antigen tests compared to molecular tests.
- For testing direct human anterior nasal swab specimens only. Viral transport media (VTM) should not be used.
- Antigen levels may decrease with illness duration; specimens after 6 days are more likely to be negative.
- A negative result may occur if antigen levels are below the detection limit or due to improper sample collection.
- Performance evaluated using provided IFU; modifications may alter performance.
- Detects both viable and non-viable SARS-CoV-2. Performance correlates with viral antigen amount, not necessarily viral culture.
- Test results must be evaluated with other clinical data. Failure to follow procedures may invalidate results.
- Positive results do not rule out co-infections.
- Negative results do not rule out SARS-CoV-2 infection, especially for those in contact with the virus. Follow-up molecular testing is recommended.
- Negative results are not intended to rule in other non-SARS viral or bacterial infections.
- Negative results should be treated as presumptive and confirmed with molecular assay if necessary.
- Asymptomatic individuals should test at least twice over three days (24-48 hours between tests).
- Higher chance of false negatives with home use tests than laboratory molecular tests.
- Serial testing (daily or every other day) is more likely to detect COVID-19, especially without symptoms.
- Performance based on specimens collected in December 2021; performance may vary with circulating variants.
Storage and Stability
Store kit at 36–86 °F / 2–30 °C, protected from direct sunlight. Do not freeze. Expiry date is on external packaging.
Test Procedure
Prepare to Perform the Test
- Bring test kit to room temperature (59–86 °F / 15–30 °C).
- Wash hands with soap and water or use hand sanitizer. Rinse thoroughly and dry hands.
- Check test expiry date on foil pouches. Do not use if expired. Testing should commence immediately after opening sealed pouches.
- Open foil pouch 1, tear along the line. Remove test device and desiccant package. Place test device on a flat surface.
- Ensure test device is intact. Desiccant package should contain white and yellow beads (no green beads). Do not open desiccant package.
Test Procedure Steps
- Open foil pouch 2. Place one tube and one nozzle cap on a table. Carefully open the tube seal without spilling liquid. Place the tube in the tube holder. If liquid spills, do not use the tube.
- Remove swab from packaging, touching only the handle.
- Gently insert the foam end of the swab into the nostril approximately ¼ inch (approx. 1.5 cm).
- Swab Both Nostrils: Rotate swab at least 5 times against the inside walls of the nostril for a total of 15 seconds. Do not just spin. Gently remove the swab and repeat in the second nostril with the same end. (WARNING: Inaccurate results may occur if nasal swab specimen is not properly collected. For children, insertion depth may be less than ¼ inch; a second person may be needed to hold the child's head.)
- Insert swab into the tube until the soft pad is in the liquid. Squeeze the tube at the bottom and hold tight. Stir the swab more than 10 times to transfer material.
- Remove swab while squeezing the tube sides to extract liquid. (WARNING: Failure to squeeze the tube can lead to incorrect results.)
- Dispose of swab and seal tube securely with the nozzle cap. Ensure cap is fitted before next step.
- Hold tube upright above the sample well. Drop 4 drops onto the sample well. (Do not apply liquid in the rectangular result window.)
- Set timer and read the test result at 20 minutes. Do not read before 20 minutes or after 30 minutes. (WARNING: Do not move or lift the test device during this time.) Dispose of used test in household trash; do not flush or pour liquids down a drain.
Read and Interpret the Results
(WARNING: Inaccurate interpretations may occur if results are read before 20 minutes or after 30 minutes.)
Look at the result window for lines at "C" (Control) and "T" (Test). A colored line at "C" indicates the test is working.
Negative Result
If a control line (C) is visible and a test line (T) is not visible, the result is negative. It is unlikely you have COVID-19. Continue hygiene and safety measures. If symptoms persist or worsen, contact your doctor. The test may be false negative or indicate another infection. Negative results do not rule out COVID-19. If you have no symptoms and a negative result, re-test in 24–48 hours.
Positive Result
If both a test line (T) and a control line (C) are visible (even faint lines), the result is positive. It is very likely you have COVID-19. Contact your doctor/local health authority immediately and follow self-isolation guidelines. Your doctor may require a molecular PCR test for confirmation. There is a small chance of a false positive result.
Invalid Result
If the control line (C) is not visible, the result is invalid. The test is not working correctly. Perform another test with a different kit. If the result remains invalid, contact Roche HCP Support at 1-866-987-6243.
Clinical Evaluation
The clinical performance was evaluated in a prospective study across 5 US clinical sites. Participants with symptoms suspicious of COVID-19 were enrolled. Those beyond 7 days of symptom onset were excluded. Participants aged 14+ self-collected swabs; younger participants were sampled by an adult. A comparator RT-PCR test was used. Out of 138 enrolled participants, 128 provided valid results. The COVID-19 At-Home Test correctly identified 41 of 43 SARS-CoV-2-positive individuals and 85 of 85 SARS-CoV-2-negative individuals.
Performance Summary Against RT-PCR Comparator
| SARS-CoV-2 Antigen Test Results | RT-PCR Results | ||
|---|---|---|---|
| Positive | Negative | Total | |
| Positive | 41 | 0 | 41 |
| Negative | 2** | 85 | 87 |
| Total | 43 | 85 | 128 |
Relative sensitivity: 95.3% (95% CI*: 84.5 – 98.7%)
Relative specificity: 100% (95% CI*: 95.7 – 100 %)
*Two-sided 95% confidence interval calculated using Wilson Method. **Two discordant (false-negative) samples were re-tested on a different high-sensitivity RT-PCR method and tested negative.
Relative Sensitivity Stratified by Days Post Symptoms Onset (DPSO)
| DPSO | RT-PCR Positives | Rapid Antigen Positives |
|---|---|---|
| 0-1 | 3 | 2 |
| 2 | 16 | 15 |
| 3 | 10 | 10 |
| 4 | 12 | 12 |
| 5 | 1 | 1 |
| 6 | 1 | 1 |
| All | 43 | 41 |
Performance Stratified by Age Groups
| Age group | RT-PCR Positives | Rapid Antigen Positives |
|---|---|---|
| < 14 | 5 | 5 |
| 14 - 24 | 8 | 8 |
| >24 - 64 | 29 | 27 |
| ≥ 65 | 1 | 1 |
| All | 43 | 41 |
Analytical Performance
Limit of Detection (LoD)
The LoD for SARS-CoV-2 was determined to be 1.4x10³ TCID₅₀/mL.
Cross-reactivity
No cross-reactivity was observed for most tested organisms, except for SARS-coronavirus at 1.58 × 10⁴ TCID₅₀/mL. Cross-reactivity was not observed for SARS-CoV at 1.58 × 10¹ TCID₅₀/mL. These results are expected as the test targets the nucleocapsid protein, which is homologous in SARS-CoV and SARS-CoV-2.
| Microorganism / Specimen | Concentration Tested for Cross Reactivity | Result |
|---|---|---|
| Human coronavirus 229E | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Human coronavirus OC43 | 8.50 × 10⁴ TCID₅₀/mL | NEG |
| Human coronavirus NL63 | 1.17 × 10⁵ TCID₅₀/mL | NEG |
| SARS-coronavirus | 1.58 × 10⁴ TCID₅₀/mL | POS |
| SARS-coronavirus (1:1000) | 1.58 x 10¹ TCID₅₀/mL | NEG |
| MERS-coronavirus | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Adenovirus | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Human metapneumovirus 4 Type B2 | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Parainfluenza virus 1 | 5.50 × 10⁵ TCID₅₀/mL | NEG |
| Parainfluenza virus 2 | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Parainfluenza virus 3 | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Parainfluenza virus 4b | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Influenza A | 1.43 × 10⁵ CEID₅₀/mL | NEG |
| Influenza B | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Enterovirus 68 | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Respiratory syncytial virus | 1.43 × 10⁵ PFU/mL | NEG |
| Rhinovirus | 1.43 × 10⁵ TCID₅₀/mL | NEG |
| Haemophilus influenzae | 1.00 ×10⁶ CFU/mL | NEG |
| Streptococcus pneumonia | 1.00 × 10⁶ CFU/mL | NEG |
| Streptococcus pyogenes | 2.59 × 10⁶ CFU/mL | NEG |
| Candida albicans | 1.00 × 10⁶ CFU/mL | NEG |
| Bordetella pertussis | 1.00 × 10⁶ CFU/mL | NEG |
| Mycoplasma pneumonia | 2.57 × 10⁸ CFU/mL | NEG |
| Chlamydia pneumoniae | 1.00 × 10⁶ IFU/mL | NEG |
| Legionella pneumophila | 1.00 × 10⁶ CFU/mL | NEG |
| Mycobacterium tuberculosis | 1.00 × 10⁸ CFU/mL | NEG |
| Pneumocystis carinii | 1.00 × 10⁶ nuclei/mL | NEG |
| P. jiroveci-S. cerevisiae | 8.10 × 10⁵ CFU/mL | NEG |
| Staphylococcus aureus subsp. aureus | 1.00 × 10⁶ CFU/mL | NEG |
| Staphylococcus epidermidis | 1.00 × 10⁶ CFU/mL | NEG |
| Pooled Negative Matrix | N/A | NEG |
Microbial Interference
No microbial interference was observed for tested microorganisms when spiked into pooled negative nasal matrix with SARS-CoV-2 positive samples.
Endogenous / Exogenous Cross-Reactivity Study
No cross-reactivity was observed for the following substances at indicated concentrations when spiked into pooled negative nasal matrix.
| Potentially Interfering Substance | Concentration | Result |
|---|---|---|
| Human Whole Blood (EDTA tube) | 4% v/v | NEG |
| Mucin (Porcine Stomach, type II) | 0.5% | NEG |
| Chloraseptic (Menthol/Benzocaine) | 1.5 mg/mL | NEG |
| Naso GEL (NeilMed) | 5% v/v | NEG |
| Nasal Drops (Phenylephrine) | 15% v/v | NEG |
| Nasal Spray (Oxymetazoline) | 15% v/v | NEG |
| Nasal Spray (Cromolyn) | 15% v/v | NEG |
| Zicam | 5% v/v | NEG |
| Homeopathic (Alkalol) | 10% v/v | NEG |
| Sore Throat Phenol Spray | 15% v/v | NEG |
| Tobramycin | 4 µg/mL | NEG |
| Mupirocin | 10 mg/mL | NEG |
| Tamiflu (Oseltamivir Phosphate) | 5 mg/mL | NEG |
| Fluticasone Propionate | 5% v/v | NEG |
| Body & Hand Lotion (Cerave) | 0.5% w/v | NEG |
| Body Lotion with 1.2% Dimethicone | 0.5% w/v | NEG |
| Hand Lotion (Eucerin) | 5% w/v | NEG |
| Hand Sanitizer with Aloe, 62% Ethyl Alcohol | 5% v/v | NEG |
| Hand Sanitizer Cream Lotion (Vaseline) | 15% v/v | NEG |
| Hand Sanitizer, 80% Ethanol, Fast Drying | 15% v/v | NEG |
| Hand Soap Liquid Gel (Soft Soap) | 10% w/v | NEG |
Endogenous / Exogenous Interference Substances Study Summary
Interference studies were performed with SARS-CoV-2 positive samples. No interference was found, except for hand soap liquid gel, which caused a false negative result at 10% w/v and 5% w/v. A positive result (no interference) was observed at 1% w/v.
High-Dose Hook Effect
SARS-CoV-2 cultured virus did not show a hook effect at a concentration of 2.80 x 10⁶ TCID₅₀/mL.
Manufacturer and Distributor Information
Manufacturer: SD Biosensor, Inc.
Distribution in USA by: Roche Diagnostics, Indianapolis, IN
Support: COVID-19 General Support 1.866.987.6243
Website: diagnostics.roche.com
