Instructions for Use
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380237-C

970000English(5) To use a blood sample, 30 µL of the 334 mM NaCl solution
should be added to the Heating Tube.
(6) Do not freeze and thaw any sample repeatedly before use.
(7) Clean the entire work area (counter tops, incubator surfacesand pipettes) with over 0.5% sodium hypochlorite before andafter performing the test and rinse with water. Allow to drycompletely before proceeding with additional testing.
(8)In handling this product, pay due attention to samplesample or sample-reagent contamination. In particular, thepipette tip should be changed every time.
(9) Do not pipette by mouth.
(10) Aerosol discharged during sample collection may allow
template DNA to disperse in the testing area, leading tocontamination. The LoopampTM PURE DNA Extraction Kit
should not be used in the same room where sample is collected.
(11) The transfer of sample to the Heating Tube and the DNA
amplification should be carried out in separate rooms or areas
in order to avoid cross-contamination.
(12) If gloves come in contact with sample or DNA solution,
immediately change gloves to avoid contaminating othersamples.
(13) In the event of contamination of the work area or equipmentwith processed sample or DNA solution, thoroughly clean thecontaminated area with over 0.5% sodium hypochlorite andrinse thoroughly with water. Allow surfaces to dry completely
before performing the operation again.
(14) After the heating step, the Heating Tube and any solution
treated with this product should be used immediately.
(15) After dispensing the DNA solution, carefully dispose of all tubes
as described in the measurement procedure in a plastic bagwith zipper, in order to avoid DNA contamination of the workarea.
(16) Reagent pouches containing unused tube must be carefully resealed after opening.
(17) Do not use the LoopampTM PURE DNA Extraction Kit after its
expiration date.
(18) The Heating Tube contains 0.74% Sodium Hydroxide (CAS No.
1310-73-2) which is classified by applicable European
Community Regulation as Skin and Eye Irritant. The pH ofSodium Hydroxide solution in the Heating Tube is about 13.
Avoid any contact with eyes, mouth, or skin. In case ofaccidental contact of any reagent with eyes, mouth, or skin,immediately rinse the affected site with running water and seek
medical advice.

LoopampTM PURE DNA

Extraction Kit
INTENDED USE
The LoopampTM PURE DNA Extraction Kit provides a fast andsimple method for extraction and purification of DNA from clinicalsamples including raw or NALC-NaOH treated sputum. The
extraction and purification step of the kit is not automated. The kit isintended to be used in professional laboratories and hospitals byadequately trained personnel. The DNA solution obtained using theLoopampTM PURE DNA Extraction Kit is suitable for LAMP-basedamplification.

CONTENTS OF THE KITReagents are stable until the date on the label assuming thecontainer remains unopened at a storage temperature of 2 – 30°C.
1) Heating Tube

1 x 90 tubes

The following reagents in each heating tube.
Sodium hydroxide
Sodium chloride
2) Adsorbent Tube

1 x 90 tubes

3) Injection Cap

1 x 90 caps

PRINCIPLE OF THE METHOD
The LoopampTM PURE DNA Extraction Kit is based on the PURE
(Procedure for Ultra Rapid Extraction ) method. The LoopampTM
PURE DNA Extraction Kit comprises three components :1) Heating Tube
The sample is added to the Heating Tube, which contains
Sodium Hydroxide solution (extraction solution). By incubating at
an appropriate temperature, microorganisms in the sample are
lysed and DNA is released into the solution.
2) Adsorbent Tube
The Adsorbent Tube contains a porous adsorbent powder. When
the Heating Tube is attached to the Adsorbent Tube, theextraction solution in the Heating Tube is mixed with the porous
adsorbent powder in the Adsorbent Tube which removes
proteins and other contaminants from extraction solution thatmight inhibit LAMP-based amplification.
3) Injection CapThe Injection Cap is attached to the Adsorbent Tube before
eluting the DNA. The Injection Cap has a built in membrane
which filters nucleic acids through it while blocking the porous
adsorbent powder and the contaminants.

WARNING AND PRECAUTIONS(1) For in vitro diagnostic use only.
(2) Samples should be handled as infectious using establishedlaboratory procedures and/or institutional guidelines. Always
wear disposable gloves, masks, goggles, and other appropriate
protective equipment. Whenever possible, handle any sample
in a safety cabinet.
(3) The LoopampTM PURE DNA Extraction Kit can be used for raw
or NALC-NaOH sputum sediments, and other samples. If using
raw sputum, use the most purulent sputum whenever possible.
(4) A sample containing a large amount of blood may affect LAMPbased amplification, if using samples other than blood.

1(5) Invert the Heating Tube three to five times to mix the content,
and then flick the tube down to collect the solution to the bottom.
(6) Change gloves.
(7) Place the Heating Tube in the heating block pre-heated up toproper temperature and incubate the tube for 5 minutes.

Warning

Note: Refer to the manual of the heater. Do not touch theblock to avoid burns.

H315

Causes skin irritation

H319

Causes serious eye irritation

P264

Wash hands thoroughly after handling

P280

Wear protective gloves/protective
clothing/eye protection/face protection(8) Remove the Heating Tubes immediately and allow the tubes tocool down at room temperature for 2 minutes. Invert each tube
three to five times to mix the content.

P302 + P352

IF ON SKIN: Wash with plenty of soapand water

Note: Be careful in removing the Heating Tube from theheating block to avoid burns.

P332 + P313

If skin irritation occurs: Get medicaladvice/ attention

P362

Take off contaminated clothing andwash before reuse

P305+P351+P338

IF IN EYES: Rinse cautiously withwater for several minutes. Remove
contact lenses, if present and easy todo. Continue rinsing(9) Remove the cap of the Adsorbent Tube, and connect theHeating Tube to the Adsorbent Tube by twisting the HeatingTube. DO NOT DISCARD THE CAP. See Step 11(10) Shake the obtained tube assembly vigorously: Ten times inhorizontal directions and ten times in vertical directions or until
all the powder has become slurry. After that, lay it down on therack.

P337 + P313

If eye irritation persists: Get medicaladvice/ attention

Note: Make sure that the extraction solution and theadsorbent powder are properly mixed and all theadsorbent powder has become slurry. If any portion of
the powder or a blue color remains, repeat this step.
Note that the color indicator serves only as a reference,and might be affected by the color of the sample（e.g.
bloody samples ）. In such a case, check for any
remaining portion of white powder only.

WASTE DISPOSAL(1) Leftover samples and kit components that have come in contact
with the samples pose a potential risk for infection. When
handling such materials, abide by your institution's standard forhandling biohazard substances.
(2) In discarding any remaining portion of the reagent in thisproduct and waste fluid after use, abide by your institution'sstandard for handling biohazard substances.
(3) The main materials for the packages and containers of thereagent are PP and PE, and that for the kit case is paper.
(4) Dispose of any used kit component, packaging or labware inaccordance with local regulations.

(11) Attach the cap removed in Step 9 to the nozzle of the Injection
Cap.
(12) Hold the Adsorbent Tube upside-down (Heating Tube facingdown ) and connect the Injection Cap to the Adsorbent Tube.
The tabs on the Adsorbent Tube (located on the outer side )should be aligned with those on the Injection Cap, then push
the tube into the cap and twist the tube until both tabs arealigned again.
(13) Flick the tube to collect the solution to the bottom of the tube.
(14) Carefully remove the cap from the Injection Cap. Do not discard
the cap. Avoid touching the nozzle. Squeeze the Adsorbent
Tube and dispense 30 L of DNA solution in the reaction tube.

MATERIALS REQUIRED BUT NOT PROVIDED
1）HumaLoop T, M , HumaHeat or other heating block
When a heating block is used, use one with a temperature settingof an appropriate temperature and compatibility with the HeatingTube. For usage, refer to the instruction for use of the heatingblock.
2）Pipette-60 Set

Note: Do not squeeze the Adsorbent Tube forcefully. Wait
about five seconds for the solution coming out.

STORAGE AND HANDLING(15) After dispensing the DNA solution, carefully recap the Injection
Cap and dispose of it in a plastic bag with zipper immediately
in order to avoid DNA contamination of the work area.

(1) The LoopampTM PURE DNA Extraction Kit should be stored at
2 – 30°C. The reagents are stable until the expiration date on
the label.
(2) After opening, aluminum pouches containing unused tubes
must be carefully re-sealed to avoid contamination andmoisture absorption. If stored as described above, this productis stable until the expiration date on the label.

NOTICEIn case of occurrence of any serious incident that has occurred inrelation to the device shall be reported to the authorised
representative, the manufacturer and the competent authority of theMember State in which the user and/or the patient is established.

OPERATION PROCEDURE(1) Turn on the HumaLoop T, M, the HumaHeat or the other heatingblock.
(2) Wipe down work surfaces and pipettes with over 0.5% sodium
hypochlorite prior to starting. Sodium hypochlorite must be incontact with the surface for at least 5 minutes. Work surfaces
may be wiped with water to remove the sodium hypochlorite.
(3) Label a sufficient number of Heating Tubes to test the samples
and 1 negative control.
(4) Dispense 60 µL of sample into the Heating Tube using thePipette-60 Set or any pipette-like tool. To use a blood sample,
dispense 30 µL of it and 30 µl of the 334 mM NaCl solution into
the Heating Tube using any pipette-like tool.

2

ORDERING INFORMATION
Product CodeProduct Name
TM

Contents

970000Loopamp PUREDNA Extraction Kit

90 tests

971000

Pipette-60 Set

1 pipette;
4 x 96 tips

961000

HumaLoop T

962000

HumaLoop M
HumaHeat

964000

Incubator

1 Main unit;
1 Fluorescence
Detection Unit
1 Main unit;
1 Fluorescence
Detection Unit
Heat Block

TABLE OF SYMBOLS
Catalog number

Consult
instructions foruse

Expiration dateIn vitro
diagnostic
medical device

Manufacturer

Temperature limitation

Batch code

Contains sufficientfor <n> tests

Authorized
Representative in
the European
Community

Importer

HUMAN Gesellschaft für Biochemica
und Diagnostica mbH
Max-Planck-Ring 21, 65205 Wiesbaden, Germany

http://www.eiken.co.jp/en3

Date of Issue: March 1, 2022