The product has to be used with ENNOLIFE Clinical Chemistry Analyzer.

The product employs immunomagnetic assay and microfluidic design that is used with analyzer of full-spectrum, and it could detect 3 samples for COVID-19 antigen (nucleocapsid protein) in 25-30 minutes (including pretreatment). It applies to early detection of COVID-19 infected.

Full Spectrometer Analyzer
Immunomagnetic Assay (IMA)
Mono-antibody for COVID-19 Nucleocapsid Protein
Sample type : Swab / UTM
3 samples / 25-30 minutes (including pretreatment)
Quantitative Results

LoD (Limit of Detection) Test
Concentration TCID50/mL (Swab) Number Positive/Total % Detected
125.6 20/20 100%

Cross-Reactivity Test
Potential Cross-Reactant Results (Tested in triplicate)
Virus Corona virus (HCoV-OC43) Negative
Corona virus (HCoV-229E)
Influenza A virus (A/TW/344/19(H1N1))
Influenza B virus (B/TW/2129/19 Victoria)

Interfering Substance Test
Potential Interfering substance Concentration Results (Tested in triplicate)
Ibuprofen 2.425 mM Positive
Blood(human), EDTA anticoagulated 5% (v/v)
Biotin 100 μg/mL
Saline Nasal Spray 10% (v/v)
Mucin 100 μg/mL
Tobramycin 5 μg/mL

ISO 13485
CE (Ongoing)
Taiwan FDA (Ongoing)

According to previous studies, most patients infected with COVID-19 also suffer from other chronic diseases, such as hepatitis, nephritis, cardiovascular disease, diabetes and so on. The ENNOLIFE clinical chemical analyzer not only detect the antigen of COVID-19 but also markers of other chronic diseases. It could achieve multiple diagnosis in one machine.

  Product Name  ENNOLIFE COVID-19 Antigen Test
  Catalog Number  001-218C
  Kit Size  24 tests
  Storage Condition  2 - 8°C / 35.6 - 46.4°F
  Control  Positive and negative, included in kit