LAMPIGEN is a vitro diagnostic and point of care screening test for SARS-CoV-2 virus based on Reverse Transcription Loop-mediated isothermal Amplification (RT-LAMP) technology.
LAMPIGEN Fluoremetric uses fluoremetric detection method and associated with fluoremetric RT-LAMP devices (Genie® II, III and HT). These are all portable devices.
LAMPIGEN gives results in 30 minutes which is great advantage over PCR testing.
LAMPIGEN Fluoremetic testing is simple to process and easy to interpretate. A high-skilled technician is not needed;
LAMPIGEN supplies all necessary components in its kit box
After collecting a sample form nostrils and mouth of a patient with the aid of swab; it is placed in VTM. The tail of the swab is broken and the body is left into the VTM. Both swabs and VTM are present in the kit box
Since two genes are tested
samples should be tested in duplicates in two tubes.
First put 17,5 μl of mastermix to two adjacent tubes. Then add 2,5 μl of primer mix-1 into the first tube and 2,5 μl of primer mix-2 into the second tube.
A fresh reaction mix should be prepared before each batch of samples is tested.
Samples should be tested in duplicate: wells 1&2; wells 3&4; wells 5&6; wells 7&8. Duplicates must be set up in the configuration shown in the figure. One pair of controls should be placed in each run.
The Genie® HT device detects amplified product in real-time using fluorescence detection. It automatically run an anneal curve at the end of amplification, where the reaction is heated to 98°C and slowly cooled. This acts as a secondary confirmatory check - ensuring LAMP amplicons are specific to SARS-CoV-2. The final result is interpreted and reported automatically
HT device can processes up to 12 strips-of-8 tubes simultaneously. Maximum 47 samples in a single run; but it can run even for one patient
LAMPIGEN detects 2 genes with Fluoremetric Method which is sensitive enough for only 3 to 5 copies in μl
|Overall Diagnostic Sensitivity1,2||100%|
|Overall Diagnostic Specificity||97%|
1: % Detection of samples with CT <30a (41 qRT-PCR positive samples) goes to 80% which is concordant with RT-qPCR to detect positives
2: % Detection of samples with CT <25a (Very high viral load; high risk of shedding) (25 qRT-PCR positive samples)