Fapon COVID-19 Antigen Test Solution

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.  

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

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.

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

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.

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

Performance

Sensitivity - Minimum detection limit: 0.51pg/mL

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