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.
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.