New Coronavirus COVID-19 Antibody

Detection Kit (Colloidal Gold)

CE、ISO9001、ISO13485、SGS、CNAS、Name List of Medical

Devices and Supplies Companies with Certification/Authorization
from other Countries

Phone：(+86) 13662276937
Email ：norahzhou@runmeigene.com
Website：www.runmeigene.com
Company Profile

Hunan Runmei Gene Technology Co., Ltd. is a high-tech company

initiated by a team of doctors with backgrounds of studying and
researching at famous universities and research institutes. We
have been fully dedicated to the establishment of the largest
domestic human health genetic testing, antigen and antibody
testing platform, individual genetic big data service platform and
auxiliary diagnosis, curative effect evaluation, recurrence and
metastasis monitoring product system and pathogen biological
nucleic acid POCT product system.
Based on innovative R&D center in Changsha, China, Runmei
understands its capability and social responsibility to offer
products consistent in quality, accurate and reliable in test
results, easy to use and accessible to laboratories of all levels
despite their variety in lab environment.
"Survival by quality, development by innovation; win the market
by speed, establish brands by service" is our constant policy.
Product Selling Point
 Assay Procedure

Step 1 Step 2 Step 3

Bring the specimen and test components to room temperature, Open the foil pouch and remove test strip. Be sure to label the test strip
Mix the specimen well prior to assay once thawed. Place the test strip on a clean, flat surface. with specimen ID number.

Step 4 Step 5

Suck up the serum, plasma or whole blood with
transfer pipette as shown in the image below. The
volume of the specimen is about 10µL.
Immediately add 2 drops (about 60-80µL) of Sample
Diluent into the Sample well (S well) with the bottle
vertically.
Read the result at 15-20 minutes. Positive results
10µL serum, plasma or whole
blood sample to S Well.
2 Drop of Sample Diluent to S
Well.
’
may be visible in as short as 1 minute. Don t read
result after 30 minutes. To avoid confusion, discard
Resulits in 10-15 minutes the test strip after interpreting the result.
 Interpetation Of Assay Result

2.3 The colored line in the control line region (C) appears and
1.NEGATIVE RESULT: The colored line in the control line
two colored lines should appear in test line regions G and M (G
region (C) appears. No line appears in test line regions G
and M). The color intensities of the lines do not have to match.
and M (G and M).
The result is positive for IgG & IgM antibodies and is indicative
of secondary COVID-19 infection.

2.POSITIVE RESULT:
2.1 The colored line in the control line region (C)
appears and a colored line appears in test line region M
(M). The result is positive for COVID-19 virus specific-IgM
antibodies and is indicative of primary COVID-19 infection. 3 INVALID: If no C line appears , the result is invalid regardless
of any colored line in the test lines (G and M) below. Repeat the
assay with a new strip.

2.2 The colored line in the control line region (C)

appears and a colored line appears in test line region G
(G). The result is positive for COVID-19 specific-IgG and is
probably indicative of secondary COVID-19 infection.
Certificate

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Certificate

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Certificate

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Packaging Information

Composition:

1.Individually sealed foil pouches containing:

a. One test strip

b. One desiccant
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2.Transfer pipette 业务学习
3.Blood taking needle

4.Alcohol prep pad

5.Sample diluent (5ml/bottle)

6.One package insert (instruction for use)

30 Serving per box

Packaging Information

Rapid Detection Kit

unit piece volume（CM） weight(KG)

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per box 30 15.5*11*11 0.35

per carton 52*30 65*40*45 19.5

per pallet 14*52*30 120*105*135 273