25 er - GenBody Influenza/COVID-19 Ag Multi

Genbody Inc.SKU: GEN-INCV-25
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€200,00

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GenBody Influenza / COVID-19 Ag Multi is an immunochromatographic assay kit for the qualitative and simultaneous detection of the antigens of the influenza virus (type A and B) and SARS-CoV-2 in nasopharyngeal swabs from humans.

 

 

Specifications:

  • Store at 2 ~ 30n
  • Specimen: Human nasopharyngeal swab and oropharyngeal swab (optional)
  • Test time: 15-20 minutes
  • Shelf life: 12 months from the date of manufacture
  • 25 tester

 

Instructions for use for download

 


Diagnostic performance
[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).
• 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 adenovirus Type 23, Human Adenovirus Type 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.

2. Disturbance

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

3.Prozone effect (hook effect)

No Prozone effect at 1.15 x 107 TCID50 / ml or at 1,000 ug / ml nucleoprotein of SARS-CoV-2.

4. Clinical study

As part of the strict IRB regulation, we collected a total of 130 patient samples that were confirmed as COVID-19 positive (30 samples) and negative (100 samples). The confirmatory method was the RT-PCR kit (Korean FDA-EUA approval).

The overall diagnostic performance of the kit;
• Sensitivity = 90.0%, specificity = 98.0%, accuracy = 94.0%

 

[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).
• Cross-reactivity: There was no cross-reactivity with SARS-CoV-1, SARS-CoV-2, Human Adenovirus Type 1, Human Adenovirus 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 A, respiratory syncytial virus Human rhinovirus type 14, human rhinovirus type 42, human metapneumovirus, Escherichia coli, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus salivarius.

2. Disturbance

• Unaffected (both for influenza A and influenza B) for whole blood, mouthwash, phenylephrine, acetylsalicylic acid, beclomethasone, benzocaine, flunisolide, guaiacol glyceryl ether, menthol, oxymetazoline, tobramycin, zanamivir, oseltamosphivirphosphorus.

3.Prozone effect (hook effect)

No Prozone effect at 2.0 x 104 HA / ml in Influenza A and at 4.1 x 104 HA / ml in Influenza B.

4. Clinical study

Under the strict IRB regulation, we collected a total of 261 patient samples that were confirmed to be influenza A positive (53 samples), influenza B positive (62 samples) and negative (146 samples). The confirmatory method was the RT-PCR kit (Korea FDA approved).

 

The overall diagnostic performance of the kit;
• Sensitivity = 100.0% for Influenza A and 98.4% for Influenza B Specificity = 96.2% for Influenza A and 94.8% for Influenza BB

 

Delivery time: 3-5 working days

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