Frequently Asked Questions

The CLEO™ Covid-19 Molecular Self-Test is a molecular in vitro diagnostic test using isothermal amplification technologies for the qualitative detection of RNA from SARS-CoV-2 (the virus that causes Covid-19) in self-collected anterior nares (nasal) swab specimens. The test detects if you have an active infection with SARS-CoV-2, the virus that causes Covid-19, and can detect an infection at lower viral loads than antigen tests, allowing for earlier detection, whether or not you have symptoms.

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The CLEO™ COVID-19 test uses sevral innovative technologies that Precise Microfluidics Control Technology, Switching-Probe (Fluorescence Reverse Transcription Loop-mediated Isothermal Amplification) Technology, Multi-position Fluorescence Sensing Technology, and CrystalMix™ (Freeze-dried reagent) Technology. The CLEO™ COVID-19 test simultaneously identifies specific parts of the SARS-CoV-2 genome, called Open Reading Frame 1ab (ORF1ab) and Nucleocapsid (N), thus providing the same performance as real-time PCR. SARS-CoV-2 is the virus that causes Covid-19. The CLEO™ COVID-19 test also identifies nucleic acids from a human gene that serves as a control for sample collection, test reagents, and test execution.

Diagnostic tests for Covid-19 include molecular and antigen tests. Most currently available at-home rapid tests are antigen tests. Antigen tests look for protein markers on the outside of the virus that causes Covid-19 while molecular tests look for viral genomic material specific to the virus. The CLEO™ COVID-19 Molecular Self-Test is a PCR-like molecular test - PCR tests are conducted by clinical laboratories and are considered the gold standard for diagnostic tests. Molecular tests amplify bits of viral RNA millions of times so that an active infection can be detected even when only small amounts of virus are present. Detect is a LAMP (loop-mediated isothermal amplification) test and therefore provides faster results than traditional PCR (Polymerase Chain Reaction) tests without sophisticated laboratory equipment but with similar accuracy and quality. Antigen tests work best to see if a person is infectious by determining if they are at or near the peak of an infection. They can produce false negative results as there is some lag time between when someone gets infected and when the amounts of antigen in their samples are high enough for detection with an antigen test. The coronavirus replicates itself by putting its genetic material inside our cells. If you are testing a person at the stage when the virus is still replicating inside the cells, it may not have produced sufficient protein or shed the protein in large enough amounts to be detected yet by antigen testing. Molecular tests such as theCLEO™ COVID-19 Molecular Self-Test are able to pick up very small amounts of viral RNA very early in an infection, so there is a low chance for false negative results, including among pre-symptomatic Covid-19 cases. In a clinical study, no false positive results were observed with the CLEO™ COVID-19 Molecular Self-Test when interpreted correctly.

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