SmartAmp Reagent Kit for Detection and EMGExtraction of SARS-CoV-2 consists of 2 parts: Detection Reagent Kit and EMG Extraction Reagent Kit. The Reagents are enough for completing 96 diagnostic tests SARS-CoV-2SmartAmp Reagent Kit for Detection and EMG Extraction of SARS-CoV-2. Can be used with or without the Portable Mini Laboratory for SARS-CoV-2 Express Diagnostics - LifeCase 24-slot manual extraction (mini lab)

• ----------------DETECTION REAGENTS----------------

Compact SmartAmp Reagent Kit is designed for the in vitro qualitative and fast detection of 2019-Novel Coronavirus RNA (SARS-CoV-2) in respiratory specimens and sera intended for use in Portable Mini Laboratory for SARS-CoV-2 Express Diagnostics.The Detection Kit includes 4 tubes containing the following reagents:

• 1) Reagent Е, transparent colorless liquid;
• 2) Reagent Р, transparent colorless liquid;
• 3) PC (positive control), transparent colorless liquid;
• 4) NC (negative control), transparent colorless liquid.

Quantity:96 tests in a set.Expiry date:12 months from the production date. Do not use after the specified expiry date.Storage:

• • Store all components at -20°C... -80°C
• • After unfreezing and opening to be stored no more than 1 week at +4°C.
• • Keep reagents separate from sample material to avoid contamination.

How to use the Detection Kit to perform the isothermal amplification reaction: Before starting the reaction, defrost the reagents on dry ice. Patient’s Sample Preparation

• 1. Dispense 6 μl from the Reagent E tube into each test tube or each amplifier microtube.
• 2. Mix 10 μl of the RNA extracted from the patient sample with 4 μl from the Reagent P tube.
• 3. Add a mixed sample (14 μl) to each test tube with Reagent E.

Positive Control (PC) Preparation

• • 4. Dispense 6 μl from the Reagent E tube into each test tube or each amplifier microtube.
  • 5. Mix 10 μl from the PC tube with 4 μl from the Reagent P tube.
  • 6. Add a mixed sample (14 μl) to each test tube with Reagent E.

Negative Control (NC) Preparation

• 7. Dispense 6 μl from the Reagent E tube into each test tube or each amplifier microtube.
• 8. Mix 10 μl from the NC tube containing DNase/RNase-Free Distilled Water with 4 μl from the Reagent P tube.
• 9. Add a mixed sample (14 μl) to each test tube with Reagent E.

Perform an incubation reaction at 67°C for 25 minutes.

• ----------------EMG EXTRACTION REAGENTS----------------

Reagent Kit for the SARS-CoV-2 RNA Extraction from Biological Material (nasopharyngeal and oropharyngeal swabs, sputum) is intended for further RNA detection procedure using real-time isothermal amplification method. The Extraction Kit consists of 4 tubes with the reagents and includes:

• 1. SSB solution, transparent colorless liquid.
• 2. WS1 solution, transparent colorless liquid.
• 3. WS2 solution, transparent colorless liquid.
• 4. EB solution, transparent colorless liquid.

Quantity:96 tests in a set.Expiry Date12 months from the production date. Do not use the expired Extraction Kit.Storage: Store at t = +2... +25°C for 12 months, avoid direct sunlight! Freezing of the Extraction Kit is now allowed. The Extraction Kit is used with Pretreatment Device for the Nucleic Aside Extraction from the Biological Samples for SARS-CoV-2 Isothermal Amplification Performance. RNA Extraction Steps Using the Pretreatment Device: Swabbing of a patient is performed using a sterile swab.

• 1. First pretreatment step is a suspension of the biological material in SSB (lysis buffer)
• 2. At a second step, SSB with the destroyed virions and biomaterial residues passes through a filter column.
• 3. To completely remove any possible interfering substances from the filter surface, it is washed sequentially with WS1 and WS2.
• 4. The filter column is being dried from the possible residues of the WS1 and WS2 washing solutions, the target viral RNA is bound to the filter column.
• 5. At the last pretreatment step, the target RNA is eluted from the filter column with nuclease-free ultrapure water (EB solution).