COVID-19 Antigen Rapid Test Kits

Intended Use

The Novala Biotech COVID-19 Antigen Rapid Test is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal, nasal, or oropharyngeal swabs from individuals suspected of having COVID-19 by their healthcare provider.

This test is intended to assist in identifying SARS-CoV-2 during the acute phase of infection, when the viral antigen is typically present in the upper respiratory tract. A positive result indicates the presence of viral antigens and requires clinical correlation with patient history and additional diagnostic information. It does not exclude bacterial infections or co-infections with other viruses.

A negative result does not rule out SARS-CoV-2 infection. Results should not be used as the sole basis for treatment or clinical decisions and should be confirmed by a molecular assay where necessary. This test is intended for use by trained medical professionals or qualified personnel in laboratory and non-laboratory settings, in accordance with local regulations and instructions for use.

Summary

SARS-CoV-2, the virus responsible for COVID-19, is a novel coronavirus belonging to the β genus. It causes acute respiratory illness, with symptoms such as fever, fatigue, dry cough, nasal congestion, sore throat, myalgia, and diarrhea. The incubation period ranges from 1 to 14 days (typically 3-7 days). Both symptomatic and asymptomatic individuals can transmit the virus.

Principle of the Test

This test operates on the double-antibody sandwich principle. Monoclonal antibodies against the SARS-CoV-2 nucleocapsid protein are conjugated to colored microparticles and placed on the conjugation pad. During testing, the antigen in the sample binds to these antibodies forming an antigen-antibody complex. This complex migrates via capillary action and is captured by immobilized antibodies at the test line (T). A visible line indicates a positive result. A control line (C) confirms the test has been performed correctly.

Warnings and Precautions

  • For in vitro diagnostic use only.
  • Use only by trained healthcare professionals.
  • Do not use beyond the expiration date.
  • Follow all instructions carefully.
  • Treat all specimens as potentially infectious.
  • Dispose of used components per local regulations.

Kit Contents

Materials Provided:

  • 25 Individually sealed test cassettes with desiccants
  • 25 Extraction reagent tubes (0.3 mL each)
  • 25 Sterile swabs for sample collection
  • 1 Package insert

Materials Required But Not Provided:

  • Timer

Storage and Stability

  • Store between 4°C to 30°C (40°F to 86°F) in a sealed pouch.
  • Use within one hour after opening.
  • Avoid prolonged exposure to heat and humidity.

Specimen Collection and Handling

Collect specimens during the early phase of symptoms for highest viral load. Proper collection and handling are critical for accurate results. Acceptable specimens include direct swabs or swabs in VTM without denaturing agents. Process samples within one hour or store at 2–8°C for up to 24 hours or at −70°C for longer storage (avoid freeze-thaw cycles).

Test Procedure

Ensure all components are at room temperature (15–30°C) before use.

Direct Swab Method:

  1. Insert swab into the extraction tube and swirl 5+ times.
  2. Leave swab for 1 minute, then squeeze out liquid while removing.
  3. Cap tube with dropper tip.
  4. Apply 3 drops (approx. 100 μL) to the specimen well.
  5. Read result at 15 minutes. Do not interpret after 20 minutes.

VTM Method:

  1. Vortex specimen in VTM.
  2. Transfer 300 μL to extraction tube using micropipette.
  3. Mix thoroughly, cap with dropper tip.
  4. Wait 1 minute, then follow steps 4–5 above.

Interpretation of Results

Positive: Two colored lines appear (T and C regions).

Negative: Only control line (C) appears.

Invalid: No control line (C) appears. Retest with a new cassette.

Quality Control

  • Internal control line (C) ensures test validity.
  • External positive/negative controls are recommended for quality assurance.

Limitations

  • Qualitative only; line intensity does not indicate viral load.
  • Negative results do not exclude infection.
  • Interpretation should consider clinical context.
  • Mutations may affect test sensitivity.

Performance Characteristics

Clinical Evaluation (Nasopharyngeal Swab):

  • Location: Greece
  • Sensitivity: 96.0% (95% CI: 93.0% - 97.8%)
  • Specificity: 100% (95% CI: 99.6% - 100%)
  • Not affected by Omicron variant

Clinical Evaluation (Nasal Swab):

  • Location: Poland
  • Sensitivity: 95.5% (95% CI: 89.8% - 98.0%)
  • Specificity: 100% (95% CI: 99.2% - 100%)

Analytical Sensitivity (LoD)

  • 5.7 x 10^2 TCID50/mL using heat-inactivated SARS-CoV-2 (Isolate: Hong Kong/VM20001061/2020)

Cross-Reactivity

No cross-reactivity observed with 32 respiratory pathogens, including:

  • MERS-CoV
  • Influenza A/B
  • Adenoviruses
  • Human coronaviruses (229E, OC43, NL63, HKU1)
  • Streptococcus pneumoniae, Mycoplasma, and others

Interfering Substances

No effect on performance from substances such as:

  • Mucin, benzocaine, nasal sprays, antihistamines, antivirals, and steroids.

Hook Effect

No high-dose hook effect observed up to 1.2 x 10^7 TCID50/mL of inactivated virus.

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Instructions for use