Material Required but Not Provided - Avoid repeated thawing and freezing of the specimen.

Veri-Q PREP M16 - Ethanol (99~100%, ACS grade)

- Isopropyl alcohol (99~100%, ACS grade)
- The instructions are specified for following specimen types: Airway Clinical
sample (Nasal swab media , Sputum, alveolar lavage)
- PBS buffer (Phosphate-buffered saline) - Collect a 1~5 ml sputum sample in exclusive bottle ship at 2~8°C to a
Viral DNA/RNA Prep Kit – Airway Clinical Sample - 2.0 ml micro-centrifuge tube reference laboratory.

16TU-CV19 - Sputum liquefaction solution - Fresh samples should always be used.

Cat. No. 7A133 - Micro pipette, sterilized pipette tips - Follow universal precautions for the prevention when working with
- Table top centrifuge pathogen human specimen. These include:
- Powder-free gloves 1) Wear personal protective equipment such as safety glasses, gloves,
INTENDED USE - Heating block, Vortex mixer laboratory coats.
- Clean bench, Bio Safety Cabinet (BSC) 2) If you have cuts or abrasions on the skin of your hands, cover them with
16TU-CV19 is a reagent kit for extraction of Viral DNA/RNA from Airway
- Veri-Q PREP M16 (G2-16TU) / Machine (Cat. No. 9S101, MiCo BioMed Co., adhesive dressing.
Sample (Swab media, Sputum and ETC).
Ltd. Korea) 3) Use needles and lancets only once, and dispose of them in a “sharps”
container for decontamination.
Principle of the Procedure
Warning and Precaution 4) Remove gloves and wash your hands after completing any task involving
16TU-CV19 has applied a universal solid-phase extraction (SPE) nucleic the handling of biological material.
acid extraction process over four steps of Lysis-Binding-Wash-Elution. To Please read the instruction for use thoroughly before using the kit and check
integrity of all components in the kit before use.
dissolve the cellular components and eluted proteins in the sample, dissolve
1) This kit needs to be carried out by skilled personnel.
Preparation of working solutions
the sample with a lysis buffer based on a guanidine salt-based chaotropic
2) It should be used in combination with Veri-Q PREP M16 (G2-16TU) of MiCo 1. Washing buffer NW1
agent. The solution is put in a tube including membrane containing a silica
BioMed. Add the indicated volume of ethanol (99~100% ACS grade) to washing buffer
gel and pressurized. Then, a salt-bridge is formed by the surface dissolution
3) Use a sterile pipet tip (with filter) and a tube. NW1 concentrate. Mark the label of the bottle to indicate that ethanol was
reagent component, and the nucleic acid selectively binds to the membrane.
4) Because of the handling of clinical specimens and chemicals, proper added. Washing buffer NW1 can be stored at room temperature (15~25°C)
Then, the alcohol-based washing solution is flowed and then the pressure is
laboratory gowns, disposable gloves and protective clothing should for at least one year.
repeated 2-3 times to increase the purity of the nucleic acid bound to the
membrane. Finally, when the appropriate amount of elution reagent is added always be worn.
5) The used components should not be reused and should not be mixed with 2. Reconstitution of Proteinase K
and pressurized, the process of high-purity separation of the nucleic acid
the components in other lot kits Add the indicated volume of Buffer PSB to dissolve lyophilized Proteinase K.
from the specimen is completed.
6) The product must be stored at room temperature, but for some reagents Proteinase K solution is stable at 4°C for at least 1 year.
Material Provided marked with a storage temperature, they must be stored at that temperature.
7) If properly stored, it is stable until the expiration date stated on the product. 3. Reconstitution of carrier Molecule
Kit Contents Do not use products that have expired. Add the indicated volume of Buffer NE to dissolve lyophilized Carrier
Kit includes reagents for 100 reactions. 8) Clinical samples before nucleic acid extraction should be regarded as potentially Molecule. Carrier Molecule solution is stable at -20°C for at least 1 year.
Component infectious materials and should be prepared in a laminar flow hood.
No. Vol. Quantity Description Appearance Storage 9) After testing, all wastes should be processed with fulfillment of regulation 4. 100mL Sputum liquefaction solution (LQB)
name
of each country/region. - 1M DTT(DL- Dithiothreitol) solution : 6.5 ml
1 NPK* 22 mg 2 tubes Proteinase K White Color,
10) Laboratory Biosafety: Non-propagative diagnostic laboratory work (e.g. - Normal Saline (0.9% NaCl) solution : 93.5 ml.
2 NCM** 550µg 2 tubes Carrier molecule White Color, sequencing, NAAT) should be conducted at facilities and procedures * After use, remaining solution can be stored at 4°C for 1 month.
Pale yellow, equivalent to BSL-2.
3 NB 55 ml 1 bottle Binding buffer
odorless liquid 11) If any damage is found at device during shipment or before using, please Preparation procedure
Colorless, contact the manufacturer or dealer. 1. Turning-on.
4 NW1*** 75 ml 1 bottle Washing buffer
odorless liquid 12) And If there is a change in the performance characteristics, please make 1) Switch on the Veri-Q PREP M16 (G2-16TU) machine.
Colorless, an inquiry to the manufacturer or dealer. 2) “Check Pre-run Cartridge. Is it inserted?” will be appeared on screen.
5 NE 100 ml 1 bottle Elution buffer
odorless liquid RT 2. Pre-running
Reagent Storage, Shelf life and Handling
Proteinase K Colorless, 1) Pull upper tray out and place a “Pre-run Cartridge” on “Sample Rotor”.
6 PSB 5 ml 1 bottle Storage and Shipment
storage buffer odorless liquid 2) Open bottles of Washing 1, Washing 2 and Elution.
7 NST - 100 ea Sample tube Plastic parts The Kit should be stored at room temperature(15~25°C). During the shipment 3) Fill each buffer to the brim, close bottles and touch “Pre-run” button for
or storage under the cold ambient condition, a precipitate can be formed in initiation.
8 NET - 20 ea X 4 4
NB buffer. Heat the bottle at 65°C to dissolve completely in such a case. Using
Lid - Tray Lid precipitated buffer will lead to poor Nucleic acid recovery. Bottle name Buffer
Tray Plastic, packed Washing buffer 1 NW1 buffer
9 NETR - 9 pack Elution tray
set 3 parts
NWTR - Waste tray Shelf life Washing buffer 2 Absolute Ethanol (not provided)
This kit is guaranteed until the expiration date printed on the product box. Eution NE buffer
* Please add 1.1 ml/tube of PSB buffer to dissolve lyophilized Proteinase K.
The dissolved NPK should be store at 4°C. 4) When “Pre-run”is finished, “Check Pre-run Cartridge. Is it removed?”appeared
** Please add 550 µl /tube of NE to dissolve lyophilized Carrier molecule. The
Procedure
with beeping sound.
dissolved NCM should be store at -20°C. Specimen Collection, Storage and Safety 5) Touch “YES” button, remove “Pre-run Cartridge” and push the upper tray back.
***Please add 175 ml of Absolute ethanol (ACS Grade). - All biological specimens should be treated with universal precautions. 6) Open the bottles, fill buffers, and close caps again.
 2) Add NB, NPK and NCM according to sample amount in the tube and 4) Discard both the “Elution Cartridge” and the “Waste Cartridge” for prevention
vortex gently. Refer to the table below. from contamination.
❼ ❶ Sample Vol. 5) Close the cap of the Buffer bottles.
NB NPK NCM IPA 6) Switch off the G2-16TU at the power switch.
(Max No.)
❷ * There will be an error message “Motor Initialize (Run INIT)”. You can remove this
200 µl (16) 200 µl 200 µl
❸ 20 µl 10 µl if you touch “Init” image. But please do this after you collect samples.
500 µl §(12) 500 µl 500 µl * If you want to operate equipment one more, fills in the buffer bottles,
§The maximum number of available samples varies depending on the then go to procedure 3.
❹ volume of sample.
3) Incubate at 65°C for 10 min. (vortex several times.) Troubleshooting
4) Add Isopropyl alcohol (IPA, not provided) after referring to the table
above and vortex vigorously. Problems Recommendation
❻ ❺ 5) Centrifuge slightly to remove droplets adhered to the tube cap. The Sample Too many cells were applied to the sample tube. Ensure
6) Load pre-treated lysates into the “Sample Tubes”. tube is that no more than 1 ml of preserved sputum is applied
7) Push the upper tray back to close. clogged. to the sample tube.
5-2 Lower Airway Clinical sample (Sputum, Alveolar lavage and ETC) Increased Proteinase K incubation time at 65°C may
No. Name Explanation 1) Add 1 volume LQB solution to 1 volume sputum sample or sticky sample result in increased yields.
- If the sample is not sticky, according the procedure of upper airway Some contain samples contain very little viral DNA/
Operates and sets equipment with touch LCD, and
❶ LCD
displays User interface
clinical sample pretreatment. . RNA. This varies from individual to individual based on
2) Incubate at Room temperature for 5 min. Incubate while agitating gently Poor Viral numerous variables. Increased proteinase K incubation
Indicates the equipment status with LED Power, Error, ( If extremely sticky sputum is to be used, the reaction time is extended by DNA/RNA time at 65°C may result in increased yields.
❷ LED
Run up to 30 minutes at room temperature to ensure sufficient liquefaction yield Reagents and samples may not have been completely
❸ Button Operates and sets equipment of the sputum sample.) mixed.Always mix the sample tube vigorously after
3) Take 200~500 µl of liquefaction sample and transfer into 1.5 ml or 2.0 ml adding each reagent.
Upper tray can be manually inserted and taken out by
❹ Upper tray
pulling to install and replace sample tubes.
tube (If it is less than 200 µl, fill up with PBS until 200 µl).
Any precipitate in buffer NB should be dissolved by
5
 00 µl sample prep is strongly recommended for maximal sensitivity.
incubating the buffer 65°C or above until it disappears.
Lower tray can be manually inserted and taken out In this case, 12 sample can be extracted at the same time.
❺ Lower tray by pulling to install and replace Elution cartridge, and 4) Add NB, NPK and NCM according to sample amount in the tube and This troubleshooting guide may be helpful in solving any problems that may
clean the lower tray vortex gently. Refer to the table below. arise. For more Information, contact our Technical Support Team between
the hours of 8:30 and 5:30 (Korean standard time) at (+82) 70-5227-6000.
❻ Air vent hole Hole for discharging air inside the body(heat) Sample Vol. NB NPK NCM IPA
(Max No.)
❼ Buffer door
The door can be manually opened and closed to fill up Quality control
the buffer 200 µl (16) 200 µl 200 µl
20 µl 10 µl In accordance with MiCo BioMed’s Quality Management System, each
3. Lower Tray Setting 500 µl §(12) 500 µl 500 µl lot of 16TU-CV19 is tested against predetermined specifications to ensure
1) Pull lower tray out and place a “Waste Cartridge (NWTR)” on it. §The maximum number of available samples varies depending on the consistent product quality.
2) Place an “Elution Cartridge (NETR)” on the “Waste Cartridge” and remove volume of sample.
a lid. 5) Incubate at 65°C for 10 min. (vortex several times.) Limitation
3) Confirm the #1 mark on the “Elution Cartridge” oriented toward to front 6) Add Isopropyl alcohol (IPA, not provided) after referring to the table above
Products may be covered by pending or issued patents or may have certain
side. and vortex vigorously.
limitations. Please visit our Web site for more information.
4) Put 1~16 “Elution Tubes (NET)” in the “Elution Cartridge” and cover the lid 7) Centrifuge slightly to remove droplets adhered to the tube cap.
8) Load pre-treated lysates into the “Sample Tubes”.
on them. Reference
5) Touch “INIT” button on the screen to initialize the “Sample Rotor”. 9) Push the upper tray back to close.
1. https://www.cdc.gov/dpdx/diagnosticprocedures/index.html
4. Upper Tray Setting 6. Starting Sample Prep
1) Pull the upper tray out to open. 1) Touch “backward” button in the select protocol on screen and then “Next”
button. Micobiomed Co.,Ltd.
2) Mark sample numbers on the side of “Sample Tubes". 3rd and 4th Floor , 54 Changeop-ro, Sujeong-gu, Seongnam-
3) Put the “Sample Tubes” in the “Sample Rotor”. 2) Touch “E-Volume” button and select elution volume (50 µl, 100 µl, 150 µl).
si, Gyeonggi-do, Republic of Korea 13449
※ Place “Sample Tubes” at the same position number of the “Elution Tubes” 3) Touch “Start” button to run sample prep.
E-mail. [email protected]
4) Push the lower tray back to close. ※ Do not pull the trays out during the operation.
TEL. +82-70-5227-6000
5. Pre-treatment of Sample & lysate loading 7. Finishing Sample Prep FAX. +82-70-5227-6001~2
1) When sample prep is finished, “Sample Preparation Complete” message is
5-1. Upper Airway clinical sample (Nasal swab media, Saliva and etc)
appeared on the screen with beeping sound. OBELIS S.A
1) Take 200~500 µl of liquefaction sample and transfer into 1.5 ml or 2.0 ml 2) Pull the upper tray out and discard all the “Sample Tubes” from “Sample Bd. Général Wahis, 53, 1030 Brussels, Belgium
tube (If it is less than 200 µl, fill up with PBS until 200 µl). Rotor”. E-mail. [email protected]
5
 00 µl sample prep is strongly recommended for maximal sensitivity. 3) Pull the lower tray out and discard lid and save all “Elution Tubes” at 4°C TEL. +32-2-732-59-54 FAX. +32-2-732-60-03
In this case, 12 sample can be extracted at the same time. or -20°C.
Revision date: 04.2020