体外診断用医薬品

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In vitro diagnostic medical device

Instruction for Use: GLINE-2019-nCoV Agキット

Before use of the kit

Collection and processing of Nasal Swab Sample❶ Read the IFU (instruction for use) carefully before❸ Insert carefully the swab into the nostil approximately

running a test.

2 cm.

❺ Processing of Nasal Swab Sample by Extraction

Reagent

Tip of swabApprox. 2 cm

The procedures should be followed precisely for an accurate result.

x5

Preparation for testing・Insert the swab into the sample extraction tube, plunge andpress the swab tip up and down in the fluid for a minimum of
15 seconds, taking care not to splash contents out of thetube.

❷ Check below list.
Step ３ to step 10 is consecutive procedure.

・Remove the swab while squeezing the sides of the tube to
extract the liquid from the swab.

Confirm that all the components required for testing
are ready.
・Carefully insert the swab into the nostril, wiping mucousmembrane.
・Rotate the swab gently 5 times or more against the nasal
wall and leave the swab still for 5 seconds.
・Slowly remove the swab from the nostril.

❻ Put the tip onto the extraction tube firmly.

・Press the attached tip firmly onto the extraction tube.

・Mix thoroughly by swirling or flicking the bottom of the tube.

*Above is an image of 1 test/kit product. The design of the kit box maychange without prior notice.

Allow the test cassette and the extraction reagent toequilibrate to room temperature (20–30℃) prior totesting.
30℃❹ Using the same swab, take nasal sample from the otherside of nostril.

20℃

Approx. 2 cm

Open the cut here line on the kit box to make a welland stand the extraction tube in it.

＜NOTE＞
Dispensing tip has a small hole.

x5x5・ DO NOT hold the tube tightly
・ DO NOT shake the tube

・ DO NOT turn over the tube unnecessarily
Collect samples from both nasal cavities.
*Above is an image of 1 test/kit product. The design of the kit box maychange without prior notice.

Place the tube in the well of the kit
box after closing the tip.

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体外診断用医薬品 In vitro diagnostic medical device

Instruction for Use: GLINE-2019-nCoV Agキット

Dispensing samples

Interpretation of results❼ Take out the test cassette from its foil pouch❾ Read the result 15 minutes after dispending sample.

immediately before testing.

Disposal of used kit

15~20min
When disposing kits (including used swabs and extractiontubes) used at home, wastes should be sealed tightly in aplastic bag.
＜NOTE＞

Then put out a sealed bag according to a municipality’sregulation.

・Result obtained after 20 minutes should not be used.

After disposing used kits, infection control should be taken
properly such as washing hands with soap.

・DO NOT move the test cassette while running test.

Reference: Ministry of the Environment (Government ofJapan)❽ Dispense the sample into the sample well.
10 Interpretation of results

CTPositive
Sample well90°

3dropsC“Disposal of mask used at home”
https://www.env.go.jp/content/900537198.pdf

Bands appear both at C-line and T-line.
Bands should be recognized, regardless of theircolor tone and density.

Check the assay procedure in video「Instruction for Use: GLINE-2019-nCoV Agキット」

TA band appear only at C-line.

Contact us

Negative＜IMPORTANT＞

・Put the test cassette on a horizontal place.
・Invert the extraction tube and hold it vertically(approximately 2.5 cm above the sample well).
・Gently squeeze the ridged body of the tube,
dispensing three drops into the sample well.
・Wait for 15 minutes at room temperature (20–30℃).

Copyright

2022 MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. All Rights Reserved.

C

https://www.mblbio.com/e/inq/ivd.html

TNo visible band appear at C-line.
CT

The results are invalid and should not be used.
It is recommended that the specimen should bere-tested.

製造販売元

Invalidhttps://ivd.mbl.co.jp/＜本社所在地＞〒105-0012
東京都港区芝大門2丁目11番8号 住友不動産芝大門二丁目ビル￨記載内容は2022年11月時点の情報です。 ￨情報有効期限：2022年11月〜2025年3月末 又は 改訂版を発行するまで ￨最新の情報は当社までお問い合わせください。
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