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Performance data of NOVA Test®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)

2020-10-15

1. limit of Detection (LoD)

 

Test Procedure

a.        Trained professional personnel collected natural negative nasopharyngeal swab specimens per the Instruction for use.

b.        Virus culture was assessed with UV radiation to inactive and dilute into series of concentration with ddH2O. For detail dilution method refer to table below:

Dilution factor and Final concentration of Series dilutions

Dilution Factor

1

10

100

250

500

Final Conc.

250000

25000

2500

1000

500

Dilution Factor

1250

1,667

2,500

5,000

10,000

Final Conc.

200

150

100

50

25

c.        Trained professional personnel tests specimens per the instruction for use, each concentration for 20 replicates.

d.        Record and test results.

 

Test Result

Table 1-Results of TCID50(Lot: 20200323)

Starting Material Concentration

Diluent Concentration

2.5×105  TCID50/mL

200

150

100

50

25

Positive/Total

20/20

20/20

20/20

20/20

14/20

Result prove that the LoD of NOVA Test®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) is 50 TCID50/ml. Under this dilution 100% specimen are detected.

 

2. Cross-reactivity Analytical Specific Study

 

Pathogen materials

Type

cross-reactivity specimens

Concentration

Nasal Wash

Pooled human nasal wash

N/A

Virus

Human metapneumovirus (hMPV)

1.0 x 105 TCID50/ml

Human coronavirus 229E

1.0 x 105 TCID50/ml

Human coronavirus OC43

1.0 x 105 TCID50/ml

Human coronavirus NL63

1.0 x 105 TCID50/ml

Adenovirus

1.0 x 105 TCID50/ml

Parainfluenza virus 1

1.0 x 105 TCID50/ml

Parainfluenza virus 2

1.0 x 105 TCID50/ml

Parainfluenza virus 3

1.0 x 105 TCID50/ml

Parainfluenza virus 4

1.0 x 105 TCID50/ml

Influenza A

1.0 x 105 TCID50/ml

Influenza B

1.0 x 105 TCID50/ml

Enterovirus

1.0 x 105 TCID50/ml

Respiratory syncytial virus

1.0 x 105 PFU/ml

Rhinovirus

1.0 x 105 PFU/ml

Bacteria

Haemophilus influenzae

1.0 x 106 CFU/ml

Streptococcus pneumoniae

1.0 x 106 CFU/ml

Streptococcus pyogenes

1.0 x 106 CFU/ml

Candida albicans

1.0 x 106 CFU/ml

Bordetella pertussis

1.0 x 106 CFU/ml

Mycoplasma pneumoniae

1.0 x 106 U/ml

Chlamydia pneumoniae

1.0 x 106 CFU/ml

Legionella pneumophila

1.0 x 106 CFU/ml

 

Test Result

The results demonstrated that NOVA Test®SARS-CoV-2 Antigen Rapid Test kits have no significant cross-reactivity with these specimens(1 nasal wash,14 viruses, 8 bacteria).

 

3. Endogenous Interference Substances Study

 

Endogenous interference substances

Interference substances

Concentration

Acetaminophen

20 mg/dL

Acetylsalicylic acid

20 mg/dL

Ascorbic acid

20 mg/dL

Caffeine

20 mg/dL

Gentesic acid

20 mg/dL

Phenylpropanolamine

20 mg/dL

Salicylic acid

20 mg/dL

EDTA

80 mg/dL

Benzoylecgonine

10 mg/dL

Atropine 

20 mg/dL

Cannabinol

10 mg/dL

Ethanol  

1%

Methanol

1%

Albumin

2,000mg/dL

Glucose

2,000mg/dL

Bilirubin

1,000mg/dL

Hemoglobin

1,000mg/dL

Triglyceride

50 mg/dL

Total cholesterol

6mmol/L

 

Test Result

Table 1- Results of endogenous interference with different levels of virus

Interfering chemical analytes

SARS-CoV-2 Virus

Name

concentration

High

Moderate

Low

Assay diluent

Blank control

NA

3/3+++

3/3++

3/3+

3/3-

Acetaminophen

20 mg/dL

3/3+++

3/3++

3/3+

3/3-

Acetylsalicylic acid

20 mg/dL

3/3+++

3/3++

3/3+

3/3-

Ascorbic acid

20 mg/dL

3/3+++

3/3++

3/3+

3/3-

Caffeine

20 mg/dL

3/3+++

3/3++

3/3+

3/3-

Gentesic acid

20 mg/dL

3/3+++

3/3++

3/3+

3/3-

Phenylpropanolamine

20 mg/dL

3/3+++

3/3++

3/3+

3/3-

Salicylic acid

20 mg/dL

3/3+++

3/3++

3/3+

3/3-

EDTA

80 mg/dL

3/3+++

3/3++

3/3+

3/3-

Benzoylecgonine

10 mg/dL

3/3+++

3/3++

3/3+

3/3-

Atropine 

20 mg/dL

3/3+++

3/3++

3/3+

3/3-

Cannabinol

10 mg/dL

3/3+++

3/3++

3/3+

3/3-

Ethanol  

1% v/v

3/3+++

3/3++

3/3+

3/3-

Methanol

1% v/v

3/3+++

3/3++

3/3+

3/3-

Albumin

2,000mg/dL

3/3+++

3/3++

3/3+

3/3-

Glucose

2,000mg/dL

3/3+++

3/3++

3/3+

3/3-

Bilirubin

1,000mg/dL

3/3+++

3/3++

3/3+

3/3-

Hemoglobin

1,000mg/dL

3/3+++

3/3++

3/3+

3/3-

Triglyceride

50 mg/dL

3/3+++

3/3++

3/3+

3/3-

Total cholesterol

6mmol/L

3/3+++

3/3++

3/3+

3/3-

The results are presented on the table demonstrate that the substances did not affect the performance of the NOVA Test®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography).