抗原甲乙-自测试

1 test/kit

5 tests/kit

20 tests/kit

Packing size:
1 pc/box 、 5 pcs/box
20 pcs/box 、50 pcs/box
100 pcs/box

Specimen type:

Anterior nasal secretion

Detection Time:
15-20minutes

Shelf Life:
24 months

Storage:
2-30C°

IFU Download

Packing size:
1 pc/box 、 5 pcs/box
20 pcs/box 、50 pcs/box
100 pcs/box

Specimen type:
Nasal swabs

Detection Time:
15-20minutes

Shelf Life:
24 months

Storage:
2-30C°

Download

Packing size:
1 pc/box 、 5 pcs/box
20 pcs/box 、50 pcs/box
100 pcs/box

Specimen type:
Nasal swabs

Detection Time:
15-20minutes

Shelf Life:
24 months

Storage:
2-30C°

Packing size:
1 pc/box 、 5 pcs/box 、20 pcs/box

50 pcs/box 、100 pcs/box

Storage:
2-30C°

Detection Time:
15-20minutes

Specimen type:
Nasal swabs

Shelf Life:
24 months

IFU Download

Packing size:
1 pc/box 、 5 pcs/box 、20 pcs/box

50 pcs/box 、100 pcs/box

Storage:
2-30C°

Detection Time:
15-20minutes

Specimen type:
Nasal swabs

Shelf Life:
24 months

IFU Download

Packing size:
1 pc/box 、 5 pcs/box 、20 pcs/box

50 pcs/box 、100 pcs/box

Storage:
2-30C°

Detection Time:
15-20minutes

Specimen type:
Nasal swabs

Shelf Life:
24 months

IFU Download

Download

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MEDOMICS

Jiangsu Medomics Medical Technology Co., Ltd., founded in October 2017, is located at Biotech and Pharmaceutical Valley of the National Jiangbei New Area, Nanjing, Jiangsu Province. It is an international high-tech enterprise driven by innovation in the area of medical devices R&D, production and sales. Medomics focuses on diagnosis of microorganisms, tumors and some rare diseases, mainly engaged in the research and development, production and sales of in vitro diagnostic reagents and automatic instruments.

Test design and principle

Test design and principle

SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) uses a double antibody sandwich method to detect SARS-CoV-2 and Influenza A/B by colloidal gold immunochromatography.

When the appropriate amount of test samples treated with lysis buffer is added to the sample well of the test cassette, the sample will move forward along the test strip by capillary action. If the sample contains SARS-CoV-2 or Influenze A/B virus nucleocapsid antigen, and the concentration is higher than the limit of detection, the antigen will form immune complexes with corresponding Nucleocapsid Protein antibody labeled with colloidal gold respectively, which are captured by N line, A line, or B line. If test sample contains SARS-CoV-2 virus, forming a red N line, indicating a positive result for SARS-CoV-2. If test sample contains Influenza A virus, forming a red A line, indicating a positive result for Influenza A. If test sample contains Influenza B virus, forming a red B line, indicating a positive result for Influenza B.

Sensitivity and Specificity

The SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) was evaluated with different clinical samples whose status were confirmed by RT-PCR.

The results are shown in following tables.

Sensitivity and Specificity

The Medomcis SARS-CoV-2 Antigen

Test Kit (LFlA) was evaluated with different clinical

sam-ples whose status were confirmed by RT-PCR.

The results are shown in following tables.

1.Table 1 SARS-CoV-2 Test

2.Table 2 Influenza A Test

3. Table 3 Influenza B Test

Product Performance

Sensitivity and Specificity

FOR IN VITRO DIAGNOSTIC USE ONLY.

FOR SELF-TESTING.

PLEASE READ INSTRUCTIONS CAREFULLY

BEFORE YOU PERFORM THE TEST.

FOR IN VITRO DIAGNOSTIC USE ONLY.

FOR IN VITRO DIAGNOSTIC USE ONLY.

KIT CONTENTS

KIT CONTENTS

Test cassette

(individually in a foil pouch with desiccant)

Lysis buffer

Dropper

Nasal swab

lnstructions for use

Bio-Safety Bag

Test cassette

(individually in a foilpouch with desiccant)

Lysis buffer

Dropper

Nasal swab

lnstructions for use

Bio-Safety Bag

Preparation

Preparation

Wash and dry hands

Carefully read IFU of SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA)

Check the expiry date at the front of the foil pouch.Do not use kit components after their expiration date.

Open aluminum foil pouch
and Check the test cassette.

Check the desiccant.

Wash and dry hands

Carefully read IFU of SARS-CoV-2 Antigen Test Kit.

Check the expiry date at the front of the foil pouch.Do not use kit components after their expiration date.

Open aluminum foil pouch
and Check the test cassette.

Check the desiccant.

Anterior Nasal Secretion Test Procedure

Anterior Nasal Secretion Test Procedure

Tear the seal of the lysis buffer and place it on the test-tube rack.

For specification of 1 pc/box and 5 pcs/box, the package box can be used as test-tube rack by pushing the dotted holeson the box
For 20pcs/box, please use the provided test-tube rack in the box

lnsert the swab (stick with larger absorbent tip) into a nostril (2.5 cm). Be sure to collect any nasal drainage that may be present.

Carefully rotate the swab in a circular path against the inside of the nostril at least 5times.

Using the same swab repeat the procedure in the other nostril.

lnsert the swab into the sampling tube and rotate the swab against the inner tube wall 10 times.

Squeeze the swab from the outer tube wall 5 times.

Lift the swab above the buffer solution level,

squeeze the swab from the outer tube wall one time to leave the sample in the tube as much as possible.

Cover the tube with the dropper.

Add 4 drops processed sample extract into the
sample well.

Lay the test cassette on a clean flat surface

Read the results within15-20 mins.

Result observed after
20mins is invalid

Dispose all those used materials into Bio-safety bag and seal well.

Tear the seal of the lysis buffer and place it on the test-tube rack.

For specification of 1 pc/box and 5 pcs/box, the package box can be used astest-tube rack by pushing the dotted holeson the box For 20pcs/box, please use the provided test-tube rack in the box