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  • highly sensitive & specific
    testing in just
    30
    min
    for Covid-19
FEATURES

Fast and Accurate Testing
for Covid -19

All in One

Has swabs, VTM as well as positive and negative controls in the kit

Rapid

Gives positive result only in 30 minutes


Accurate

Detects 2 different genes* It is not a subjective test (not depends on a personal evaluation)

lampigen logo

Easy to Use

Simple to process, esay to interpret.


Sensitive

Presence of small amount of viruses are enough to detect

Portable

Its device can be moved at any PoC points

Flexible

Any number of samples from 1 to 47 can be tested in one run

*: N gene and ORF1ab gene

FLY HEALTY

COMPONENTS

Fast and Accurate Testing
for Covid -19

LAMPIGEN is

a in vitro point of care diagnostic test for
SARS-CoV-2 virus based on Reverse Transcription Loop-mediated isothermal Amplification (RT-LAMP) technology with the fluorometric detection method.

LAMPIGEN is associated with fluorometric
RT-LAMP devices (Genie® II, III and HT)and All RT-PCR devices compatable.

The current SARS-CoV-2 pandemic has created an urgent need for rapid point of care diagnostic tools. In the face of a sweeping pandemic, assays should have rapid and easy-to-read visual results. LAMPIGEN is a PoC (Point of Care) Diagnostic Test.

COMPONENTS

LAMPIGEN Fluorometric ® is associated with unique fluorometric RT-LAMP devices (Genie ® II, III and HT)
and All RT-PCR devices compatable.

WORK HEALTY

PROCESSES

Fast and Accurate Testing
for Covid -19

Swab should be inserted first into one nostril of the patient up to 2.5 cm (1 inch) from the edge of the nostril. It must be rolled 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected. Then using the same swab process should be repeated for the other nostril to ensure that an adequate sample is collected from both nasal cavities.

Then swab 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 15,5 μl of mastermix to two adjacent tubes. Then add 4,5 μl of primer mix-1 into the first tube and 4,5 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 fluorometric LAMPIGEN Kit is only applicable with specified instrument. 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

genie 2 Processes up to 12 strips-of-8 tubes simultaneously. Maximum 47 samples in a single run; but it can run even for one patient

The page screens of detection by Real Time Fluorescence showing ORF1ab gene positivity. It is a quantitative measure of assas performance

MEET HEALTY

PERFORMANCE

Fast and Accurate Testing
for Covid -19

Sensitive and Accurate Detection

  • Genes Detected
  • N gene & ORF1ab gene
  • Detection Method
  • Fluorometric

LAMPIGEN shows high sensitivity & high specificity


Overall Diagnostic Sensitivity 1 100%

Overall Diagnostic Specificity 2 97%
  • 1- 100% (samples with < CT25 )(Concordance with RT-qPCR to detect positives)
  • 2- Samples were tested using the qRT-PCR. For the statistics, it was assumed that the qRT-PCR results were correct. Cycle threshold (CT) is the number of cycles required for the fluorescent signal to cross a defined thureshold for the comparator qRT-PCR. (Concordance with RT-qPCR to detect negatives)

SHOP HEALTY

LOGISTICS

Fast and Accurate Testing
for Covid -19

LAMPIGEN LAMP KIT BOX

  • Lampigen lamp kit box has 500 tests/kit
  • exp. Date: 12 months
  • Storage conditions: -15/-25°C
  • Dimensions (LxWxH): 90.5mm x 86.5mm x 50mm

LAMPIGEN LAMPPH2020-500

  • 18 lampigen lamp kit box (9.000 test)
  • Total GW : 6.500 GR
  • Dimensions (LxWxH): 372mm x 372mm x 310mm

Big package

For Vtm:

  • Every package has 12 box (1200 pcs.)
  • GW: 13.900 GR

For Swab:

  • Every package has 12 box (6000 pcs.)
  • GW :14.000 GR

box

For Vtm: PH2020-100

  • Every box has 100 Vtm
  • Ex. Date for vtm: 12 months.
  • Storage conditions: +5/+25°C
  • Gamma irradiation

For Swab: PH2020SWAB-500

  • Every box has 500 swab
  • Ex. Date For Swab: 24 months.
  • Storage conditions: +5/+25°C
  • Gamma irradiation