TOP

Fapon COVID-19 Antigen Test Solution

Date: 2020-07-01
Views: 1455


In April, WHO explicitly stated that rapid diagnostic antigen tests are best used to identify acute or early COVID-19 infection, whereas rapid diagnostic antibody tests are to be applied in disease surveillance and epidemiologic research. Now more and more government bodies had included antigen tests in their COVID-19 diagnostic strategies. European Centre for Disease Prevention and Control, Health Products Regulatory Authority of Ireland, Ministry of Health of Japan, The Indian Council of Medical Research noted that antigen test provides rapid detection of COVID-19 positive and being a complementary tool to PCR test in the COVID-19 diagnostic protocol.

 

The application and demand for antigen detection tests are expanding globally. India conducted 660,00 tests per day, with 25%-30% used rapid antigen tests. All arrivals at the airports in Malaysia require to be tested with antigen tests if they did not get tested earlier. Japan also deployed antigen test in airports and expected to increase the daily test capacity to 10,000 per day in September. In August, seven states in the US announced to purchase in a total of 3 million tests to facilitate outbreak controls.

 

Market opportunities are unveiled now with too much demand but very few approved antigen test reagents. One of the two EUA-approved antigen test organizations, Quidel described the market demand as 'unfathomable', which brought in $56.3 million in Q2 revenue, making a 270% sales jump. FIND, a non-for-profit, WHO collaborative organization estimated 500 million COVID-19 diagnostic tests will be needed in low- and middle-income countries over the next 12 months. And 75% of which will be SARS-CoV-2 antigen-detecting rapid diagnostic tests since molecular tests for active infection detection in decentralized settings are not available.

 

To unlock the market opportunities of COVID-19 antigen detection test, Fapon introduces new raw material pairs to accelerate the development and production of antigen test reagents.  


Fapon COVID-19 Antigen Test Solution




Lateral Flow Platform


Advantages

  • High Activity, Low Detection Limit

  • Widely Validated & Recognized by Customers (CE-IVD Reagent Materials)

  • Stable Bulk Volume Supply, Monthly Availability Up to 50g


Product Information


Recommended Pairs

Catalog No.

Source

Clone

Isotype

Application

Pair 1

FPZ0573

Mouse

8A8

IgG1

Conjugate

FPZ0546

5E7

IgG1

Coating

Pair 2

FPZ0574

8F5

IgG1

Conjugate

FPZ0546

5E7

IgG1

Coating

Pair 3

FPZ0548

5F9

IgG1

Coating

FPZ0546

5E7

IgG1

Conjugate

Pair 4

FPZ0550

5F1

IgG1

Coating

FPZ0554

Goat

--

--

Conjugate

Pair 5

FPZ0547

Mouse

3B6

IgG1

Coating

FPZ0554

Goat

--

--

Conjugate


Performance


Activity Reaction to Recombinant Antigens & Viral Lysate


Reaction to Recombinant Antigens Expressed in E. coli & Eukaryotes - Detection was shown in 100 pg/mL with C8 color intensity, and 25 pg/mL with C9 color intensity.


Concentration

1.0 ug/mL

25 ng/mL

2 ng/mL

0.5 ng/mL

0.1 ng/mL

25 pg/mL

Level of Color Intensity

C1+

C1

C4

C6

C8

C9


Reaction to Viral Lysate- Detection was shown in positive to viral lysates with different dilution gradient

Dilution Ratio

1:100

1:1000

1:5000

1:30000

Level of Color Intensity

C1

C3

C5

C8

Fapon COVID-19 Antigen Test Solution

Note: the higher the number, the lower the activity, B refers to undetectable


Specificity - One hundred negative nasal swab samples were tested with 100% specificity, no false-positive results


Cross-Reactivity - Tested various respiratory tract positive samples with different concentration levels, results all showed negative, which suggested no cross-reaction and false-positive results.


Type of Pathogen

Pathogen

Category

Concentration

Result

Human Coronaviruses

HKU1

Recombinant protein

10ug/mL

No cross-reactivity

OC43

NL63

229E

Pneumonia

Mycoplasma pneumonia

Inactivated pathogen

50 ug/mL

Influenza A

H1N1

Inactivated virus

5 ug/mL

H3N2

5 ug/mL

Avian influenza A

H7N9

5 ug/mL

H5N1

5 ug/mL

Influenza B

Influenza B

5 ug/mL

Parainfluenza

Parainfluenza 2

5 ug/mL

Respiratory Syncytial Virus

Respiratory Syncytial Virus

50 ug/mL

Adenoviridae

Adenoviridae

10 ug/mL

Others

EB virus

30 ug/mL

Mumps virus

50 ug/mL

Varicella-zoster virus

50 ug/mL

Human cytomegalovirus

1:40 Dilution

Measles virus

1:40 Dilution

Rotavirus

1:40 Dilution



CLIA/CMIA Platform


Advantages

  • Applicable to AP & AE Platforms

  • High Sensitivity & Specificity

  • High Batch-to-Batch Consistency, Bulk Volume Supply

  • Customized Reagent Development

  • Bulk Reagent with Required Specifications & Components


Product Information


Recommended Pairs

Catalog No.

Source

Clone

Isotype

Application

Pair 1

FPZ0573

Mouse

8A8

IgG

Coating

FPZ0546

Mouse

5E7

IgG1

Conjugate

Pair 2

FPZ0574

Mouse

8F5

IgG

Coating

FPZ0546

Mouse

5E7

IgG1

Conjugate

Pair 3

FPZ0549

Mouse

5E4

IgG1

Coating

FPZ0546

Mouse

5E7

IgG1

Conjugate

Pair 4

FPZ0548

Mouse

5F9

IgG1

Coating

FPZ0546

Mouse

5E7

IgG1

Conjugate

Pair 5

FPZ0574

Mouse

8F5

IgG

Coating

FPZ0599

Mouse

8B3

IgG

Conjugate


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


Sensitivity - Minimum detection limit: 0.51pg/mL


Fapon COVID-19 Antigen Test Solution for CLIA


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


Cross-Reactivity (Same as Lateral Flow Platform) - Tested various respiratory tract positive samples with different concentration levels, results all showed negative, which suggested no cross-reaction and false-positive results.


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



  form>