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GeneFinder COVID-19 Testing Kit

GeneFinder COVID-19 Plus RealAmp Kit

Coronavirus COVID-19 Testing Kit

On January 11, 2020, Chinese health authorities preliminarily identified more than 40 human infections with a novel coronavirus in an outbreak of pneumonia under investigation in Wuhan City, Hubei Province, China. The Chinese authorities identified a new type of coronavirus (novel coronavirus, named as COVID-19), which was isolated on 7 January 2020.

GeneFinderâ„¢ COVID-19 Plus RealAmp Kit is the One-Step Reverse Transcription Real-Time PCR Kit designed to detect Novel Corona virus (COVID-19) qualitatively through Reverse Transcription reaction and Real-Time Polymerase Chain Reaction.

  • About 120 minutes detection for COVID-19
  • Reverse Transcription reaction and Real-Time Polymerase Chain Reaction
  • Easy-to-use(One-Tube) and interpretation
  • Reliable result by Internal/Positive/Negative Control

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The test is a nasal/throat swab test, similar to a strep or influenza test, (nasopharyngeal swab) Then utlizing the COVID-19 medium through a PCR Molecular Analyzer to determine positive of negative results.

The tests are made in South Korea by a medical device manufacturing company that has been developing and manufacturing medical devises and test kits with a proven successful track record. The manufacturer has been supplying test kits around the globe.

Yes. The kits have been administered on approximately 100,000 cases in the South Korean outbreak and are currently the main test are being used in Italy and France.

The tests do not require FDA approval. The manufacturer has completed the EUA trials and has applied to the FDA for Emergency Use Authorization. The test kits can be ordered and received into US labs and medical facilities under the Research Use Only (RUO) classification. Upon receipt of the test kits under an RUO classification, the Lab or Hospital will intiate an IRB, Instiutional Review Board and then a LDT, Laboratory Development Test.

The tests do not require CDC approval for private payer use.

CE marking indicates a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental requirements. It is required for products manufactured anywhere in the world that are marketed in the EU. The COVID-19 test kits has been third party inspected and approved. The Declaration of Conformity contains the CE mark.

Yes. COVID-19 Tests must be kept cold and delivered to cold storage. (-20 C)

This is a PCR Real-Time Test that requires ABI7500/7500Fast and CFX96 Machines.

The clinician conducting the specimen collection utilizes a nasopharyngeal swab to collect the human respiratory specimens such as alveolar lavage fluid, sputum etc. The swab is placed in the collection tube and then sent to the laboratory for testing. The specimen needs can be shipped at room temperature but should be processed within 96 hours of collection.

The tests require approximately one hour prep time and two hours processing time.

Test Kits come in packs of 100 Tests. The minimum order is 100 tests. Manufacturing capacity is currently 100,000 test kits per day.

Retail / Direct Pay Price ranges $20-$30 per test.

For the US, there are temporary CPT Codes that will reimburse around $700 per test.

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