[For COVID-19 Ag]

1. Analytical sensitivity / cross-reactivity

Detection limit LoD: 2.87 x 103 TCID50 / ml heat-inactivated SARS-CoV-2 culture fluid.it).


Cross-reactivity: There was cross-reactivity of SARS-CoV-1.

However, there were no cross-reactivities of MERS coronavirus, human coronavirus NL63, human coronavirus 229E, human coronavirus OC43, human adenovirus type 1, human adenovirus type 3, human adenovirus type 8, human adenovirus type 18, human type adenovirus type 23, human adenovirus 7, Human Adenovirus Type 5, Human Adenovirus Type 11, Human Parainfluenza Virus Type 1, Human Parainfluenza Virus Type 2, Human Parainfluenza Virus Type 3, Human Parainfluenza Virus Type 4, Human Rhinovirus Type 1, Human Rhinovirus Type 14, Human Rhinovirus Type 42, Human Metapneumovirus, Respiratory Syncytial Virus-A, Respiratory Syncytial Virus-B.rus-B.

2. Interference

Not bothered by whole blood, mouthwash, phenylephrine, acetylsalicylic acid, beclomethasone, benzocaine, flunisolide, guaiacol glyceryl ether, menthol, oxymetazoline, tobramycin, zanamivir, oseltamivir phosphate, mucus.

3. Prozone effect Hook effectt)

No prozone effect at 1.15 10 & amp; sup7; TCID 50 / ml or at 1000 µg / ml nucleoprotein from SARS-CoV-2..

(EUA approval..

 

[For Influenza A / B Ag]



1. Analytical sensitivity / cross-reactivity

Detection limit LoD: 2.87 x 103 TCID50 / ml heat-inactivated SARS-CoV-2 culture fluid.it).

Cross reactivity:There was no cross-reactivity with SARS-CoV-1, SARS-CoV-2, human adenovirus type 1, human adeon virus type 2, human adenovirus type 3, human adenovirus type 8, human adenovirus type 18, human adenovirus type 23, human adenovirus type 7, human adenovirus type 5, human adenovirus type 11, measles virus, human parainfluenza Virus Type 1, Human Parainfluenza Virus Type 2, Human Parainfluenza Virus Type 3, Human Parainfluenza Virus Type 4, Respiratory Syncytial Virus-A, Respiratory Syncytial Virus-B, Human Rhinovirus Type 1, Human Rhinovirus Type 14, Human Rhinovirus Type 42, human metapneumovirus, Escherichia coli, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus salivarius.

2. Interference

Not bothered by both influenza A and influenza B.B)
for whole blood, mouthwash, phenylephrine, acetylsalicylic acid, beclomethasone, benzocaine, flunisolide, guaiacol glyceryl ether, menthol, oxymetazoline, tobramycin, zanamivir, oseltamivir phosphate, mucus.

3. Prozone effect Hook effectt)

No prozone effect at 2.0 x 104 HA / ml for influenza A and at 4.1 x 104 HA / ml for influenza B.

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