20 tests/kit

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20 tests/kit

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这是描述信息

Packing Size:
20 pcs/box 、50 pcs/box 
100 pcs/box

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SpecimenType:

Nasopharyngeal secretion

Throat secretion

Anterior nasal secretion

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Detection Time:
15-20minutes

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Shelf Life:
24 months

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Storage:
2-30C°

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Packing Size:
20 pcs/box

50 pcs/box 、100 pcs/box

这是描述信息

Storage:
2-30C°

这是描述信息

Detection Time:
15-20minutes

这是描述信息

Specimen type:
Nasopharyngeal secretion

Throat secretion

Anterior nasal secretion

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​Shelf Life:
24 months

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MEDOMICS

 

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.
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SARS-CoV-2
Antigen Test Kit(LFIA)

 

 

Nasopharyngeal Swab 

Throat Swab 

Anterior Nasal Swab

 

 

Determine the infection of someone by
detecting viral material.

SARS-CoV-2  Antigen Test Kit(LFIA)

 

 

Nasopharyngeal Swab Throat Swab  Nasal Swab

 

Determine the infection of someone bydetecting viral material.

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Test design and principle

 

 

Test design and principle

 

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Colloidal gold-labeled anti-SARS-CoV-2 antibody is sprayed on conjugation pad.

 

Test line is fixed with anti-SARS-CoV-2 antibody for detecting the novel coronavirus.The quality control antibody is fixed on the control line.
 

Colloidal gold-labeled anti-SARS-CoV-2 Antibody

 is sprayed on conjugation pad.

 

Test line is fixed with anti-SARS-CoV-2 Antibody

 for detecting the novel coronavirus.The quality control antibody is fixed on the Control line
 

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.

 

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 Nasopharyngeal or throat secretion collection

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2.Table 2 Anterior nasal secretion collection

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Sensitivity and Specificity

 

 

Sensitivity and Specificity

 

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FOR IN VITRO

DIAGNOSTIC USE ONLY.
FOR PROFESSIONAL
USE ONLY.

FOR IN VITRO DIAGNOSTIC USE ONLY.

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Sample Requirements

 

 

 

Sample Requirements

 

01

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• Anterior Nasal Sampling
 
Insert the swab 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 5 times. Using the same swab repeat the procedure in the other nostril.

02

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• Nasopharyngeal secretioncollection:
 
Take out a swab from the pouch. Insert the swab into one of the patient’s nostrils until it reaches the posterior nasopharynx where there is the most secretion, gently rotate and rub the swab over the surface of the posterior nasopharynx for several times before taking it out.

03

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• Throat secretion collection:

Insert the whole swab completely into the throat from the mouth, centering on the throat wall and the
reddened area of the palate tonsil, wipe both sides of the pharyngeal tonsil and posterior pharyngeal wall with moderate force. Try to avoid the tongue before taking it out.
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Test Procedure

Test Procedure

Do not open pouch until ready to use. Prep necessary materials: Timer | Tube rack for sampling tubes and specimens | Any necessary personal protective equipment.
1 | Sampling: vertically add 15 drops (approximately 350 μL) lysis buffer into the sampling tube from vial or open the seal of the sampling tube containing lysis buffer or twist and squeeze out all the lysis buffer into the sampling tube from capsule. Insert the swab (aftercollection) into the buffer. Rotate the swab against the inner tube wall 10 times and squeeze the swab from the outer tube wall 5 times to completely dissolve the sample in the buffer, the outer tube wall in order to leave the sample in the tube as much as possible.Remove and discard the swab, cover the tube with the dropper.

2 | Test procedures: Open the aluminum foil pouch, take out the test cassette and lay it on a clean flflat surface, then mark the cassette with the patient ID or sample number and add 4 drops (approximately 100 μL) processed sample extract into the sample well.The result should be observed within 15-20 minutes. Results observed after 20 minutes are invalid.

DISPLAY OF THE RESULT / EXPECTED VALUE

DISPLAY OF THE RESULT / EXPECTED VALUE


“C”:Quality Control Line
“T”:Detection Line
“S”:Sample Well


“C”:Quality Control Line   

“T”:Detection Line
“S”:Sample Well

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Display of Results/Expected Values

 

Display of Results/Expected Values

• Negative result: If only the quality control C line appears and the detection T line is not visible, the sample contains no SARS-CoV-2 antigens or the SARS-CoV-2 antigens concen tration is lower than the limit of detection and the result is negative.


• Positive result: If both the quality control C line and the detection T line appear, then theSARS-CoV-2 antigens have been detected and the result is positive.


• Invalid result: If the C line does not appear, the result is invalid and a new test must be performed.

 

Note: The color intensity of the T line is related to the concentration of SARS-CoV-2 Antigens contained in the sample, and the result should be determined by whether the Tline is colored or not regardless of the color intensity.
 

External Positive and Negative Controls

 

External Positive and Negative Controls

The external controls consist of positive swab and negative swab are available. Only one red colored C line in the observation window can be seen while using a negative control swab. Both red colored C line and T line in the observation window can be seen while using a positive control swab. If necessary, please contact your local vendor or Medomics to obtain control swabs.
 

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Contact Information

E-mail:

Address:Building 01, Phase 6, No.71, Xinghui Road, Jiangbei New Area, Nanjing

 

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