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Fapon COVID-19 Antigen Test Solution for CLIA

Date: 2020-07-01
Views: 101

Fapon takes the lead in introducing the COVID-19 Antigen Test Solution to satisfy the diversified needs of the market with high-quality raw materials and quality controls. The antigen test looks for viral protein fragments as a marker to identify the presence of infection, providing onsite results in minutes.


Product Information


Raw Materials



Recommended Pairs

Catalog No.

Source

Clone

Isotype

Application

Pair 1

FPZ0549

Mouse

5E4

IgG1

Coating

FPZ0546

Mouse

5E7

IgG1

Conjugate

Pair 2

FPZ0548

Mouse

5F9

IgG1

Coating

FPZ0548

Mouse

5E7

IgG1

Conjugate

Pair 3

FPZ0554

Goat

--

--

Coating

FPZ0546

Mouse

5E7

IgG1

Conjugate

Pair 4

FPZ0573

Mouse

8A8

IgG

Coating

FPZ0546

Mouse

5E7

IgG1

Conjugate

Pair 5

FPZ0574

Mouse

8F5

IgG

Coating

FPZ0546

Mouse

5E7

IgG1

Conjugate



Others

SARS-CoV-2 N Antigen Test Component

Concentrated Ab-AE Solution

Concentrated Ab-Beads Solution

Lysis Buffer

Quality Controls

(0 pg/ml, 10 pg/ml, 50 pg/ml, 500 pg/ml, 5000 pg/ml, 100000 pg/ml)

AE Diluent Buffer

Beads Diluent Buffer


Performance


1. Sensitivity - Minimum detection limit: 0.51pg/ml


Fapon COVID-19 Antigen Test Solution for CLIA


2. Specificity - 79 negative nasal swab samples with no exceed in the blank limit (LoB), 100% negative coincidence rate was detected


3. Cross-Reactivity


Type of Pathogen

Pathogen

Category

Concentration

Result

Human Coronaviruses

HKU1

Recombinant protein

25ng/ml

&

500ng/ml

No cross-reactivity

&

Cross-reactivity 0.005%

OC43

NL63

229E

Influenza A

H1N1

Inactivated virus

5ug/ml

No cross-reactivity

H3N2

Avian influenza A

H7N9

H5N1

Influenza B

Influenza B

Parainfluenza

Parainfluenza virus 2

50ug/ml

No cross-reactivity

Pneumonia

Mycoplasma pneumonia

Inactivated pathogen

Streptococcus pneumonia

Respiratory Syncytial Virus

Respiratory syncytial virus

Inactivated virus

Adenoviridae

HAdV-3

Enteroviruses

Enterovirus A

Others

EB virus

Mumps virus

Varicella-zoster virus

Morbillivirus

Dilution*40

No cross-reactivity

Human cytomegalovirus

Rotavirus


4. Negative Samples


Sample

Result

Serum * 50

Lower than blank limit

Nasal Swab * 50



5. Quality Control - Eukaryotic expressed recombinant N protein was used as calibration material, the reactivity showed consistency with native viral lysate


Fapon COVID-19 Antigen Test Solution for CLIA






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