Polymerase Chain Reaction (PCR) used for template amplification, similar to in situ PCR
Not an all-in-one system
Users need to dilute sample, equilibrate reaction reagent from -20°C to room temperature, and ensure less than four freeze-thaw cycles.
(PCR can be done as follows without nucleic acid extraction)
1.Equilibrate frozen reaction reagent at room temperature;
2.Prepare amplification reagent in bio-safety cabinet;
3.Divide reagent into small volume, leading to repeated freeze-thaw cycle;
4.Dilute or equilibrate sample;
6.Perform template and reagent loading process in bio-safety cabinet;
7.Load sample into the instrument.
 Potential reagent waste during manual process of reagent preparation and addition.
 Repeated freeze-thaw cycle may cause a change in reagent volume and concentration, resulting in a change of reaction scheme concentration.
~20 min
60~80 min
Not applicable
1.Only non-inactivated VTM is allowed.
2.Inactivate sample for 30min at 56℃ before being loaded into the workstation.
High risk of exposure to bio-hazard substances due to relatively long time of sample loading and reagent preparation
 Not point-of-care testing.
 Similar to in situ PCR Assay, this product does not extract nucleic acid, which is viable for many other ordinary PCR products.
 No extraction and purification. False positive and false negative result may occur due to inhibitors.
Four samples each time
DirectDetect™ SARS-CoV-2 Detection Kit

In situ PCR.
No need to extract sample, but it takes a long time to liquefy sputum sample.