The COVID-19 antigen test kit is provided for use by clinical laboratories, to healthcare workers for point-of-care testing. This test kit can be used as home-test by lay person subject to local legislations. Dishang Medical Technology is working on the submission of over-the-counter (OTC) permission.
Please make sure to check with your local ministry of health or regulatory authorities before placing an order.
- Collect throat/ nasal specimen with swab.
- Apply 6 drops of antigen extraction solution to the extraction tube.
- Insert the swab into ex- traction tube, swirl the swab at least five times. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
- Press the nozzle cap tightly onto the tube.
- Apply 2 drops of extract- ed specimen to the specimen well of the test card.
- Read the test result at 15- 20 minutes.
Clinical Performance
| Relative Sensitivity: | 95.05% (88.93%~ 97.87%) |
| Relative Specificity: | 99.55% (97.47%~ 99.92%) |
| Accuracy: | 98.13% (95.98%~ 99.14%) |
95% Confidence Interval
Now we have three type packing type:
- 1 test/kit
- 5 tests/kit
- 20 tests/kit
And 20 tests/kit is the most popular and best option for bulk order. As for sample or trial order, you may apply 1 or 5 test/kit. More sample order information, please click here.
The solution will keep for 24 months if stored at temperature which ranges from 2 to 30℃. The kit is effective till the expiry date indicated on packings.
Nasal swabs, Throat swabs, BALF
There are two kinds of tests available for COVID-19: viral tests and antibody tests. RT-PCR test and antigen test are both viral test which detects the presence of SAR-CoV-2 from upper respiratory samples. The RT-PCR test targets the genomic information of the virus (RNA); however, the COVID-19 antigen test kit detects pieces of proteins that make up the SARS-CoV-2 virus. The WHO recommends both RT-PCR tests and antigen tests for the diagnosis of active coronavirus infection. Please visit the US FDA page for more information about Coronavirus Testing Basics
Regular MOQ is 500, 000 tests;
White we accept trial order/ small order above 3000 tests, price is higher.
Departure Airport Can be Shanghai or Qingdao.
One outer carton is 0.125CBM，15Kg, of 50 boxes, and each box is 20 tests.
ie 1CMB is about 8 out carton, 120Kg, or 4000 kits(inner box), or 8000 tests.
While MOQ is 500,000 tests, ie 62CBM, or 7,440Kg, usually we transport them by chartered airplane.
- This product is available now. For small quantities, delivery can be made within 1-2 weeks.
- For Large order for example 500,000 tests, delivery can be made in 3 weeks.
- Please contact us for large order quantities. Our international sales team is happy to assist you with large orders or distributor discounts.
Please note there are about 1 week to handle inspection application & Commodity inspection application. For more information, please check COVID-19 antigen test kit exportation process.
We accept 100% advance payment, as is the other medical products.
Please note the receiving Account can only be Weihai Dishang Medical Technology Co.,Ltd.
Usually we could provide free samples for about 10-40 tests. Here is the list of different packages
- Package 1 test/ kit, 10 kits free sample available;
- Package 5 tests/ kit, 2 kits free sample available;
- Package 20 tests/ kit, 2 kits free sample available;
You can choose one form above options.
Not for SARS CoV 2 Antigen Test Kit (LFIA).
Private label is available in condition that
- MOQ (minimum order quantity ) is 1.2 million tests.
- Extra cost ($0.1-0.2/test);
Uncut sheet is available for all of our lateral flow rapid diagnostic kits. Please contact us for more information.
Till now NO exclusive agent set in any country or region. You may contact us for more information.
Official export process packaged,
- A set of documents, Invoice, packing list, contract & a joint statement
- Special inspection application documents are usually approved within 5 working days
- Commodity inspection application: factory inspection, usually 1~3 days
For old customers, the quota for commodity inspection can be recorded in advance, and special inspection approval and production will be carried out at the same time.
Dishang’s COVID-19 Antigen Rapid Test Kit is not approved by the US FDA. Currently, it is not available for sale in the US.
We are working on the FDA EUA（Emergency Use Authorization） submission.
We have CE Declaration of Conformity. At present, the EU classifies the test kit into IVDD class. The access to the EU and other countries only requires a registration letter. For example, Oudi is registered with the Dutch Drug Administration The letter confirms CIBG and CE Declaration of Conformity. Please find check certificates in downloads center.
We have clinical test reports from Ukraine, Spain and China’s Jiangsu Provincial Center for Disease Control and Prevention.
– Registered in Germany (Bfarm), Philippines, Argentina, and Hungary
– Registering in Australia, India, Netherlands, Indonesia, etc.
The COVID-19 antigen test kit can be exported with the manufacturer’s Whitelist in the Medical Insurance Chamber of Commerce as an export license.
Some countries that need to register need a free sales certificate. You can consider applying for a European free sales certificate. The cost is about 1,500USD per copy.
For example, our company has applied the European Free Sale Certificate for South Africa, Argentina, Peru, the Philippines, Indonesia, Mexico, Saudi Arabia, and Mexico.
The embassy’s endorsement fee ranges from 150 to 350USD and obtained in 1-2 weeks.