New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold)

Rapid Test Kit Description

The New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold) is a qualitative membrane-based immunoassay for the detection of COVID-19 antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the Test region, anti-human IgM and IgG are coated. This kit is used to qualitatively detect the new coronavirus COVID-19 antibody (IgG/IgM) in human serum, plasma or whole blood samples. It is mainly used for auxiliary judgment and dynamic monitoring of new coronaviruses, and cannot be used as the basis for the diagnosis of new coronaviruses.

Antibody Detection Kit (Colloidal Gold) Parameters

Composition: Test Strip, Assay Buffer, Pipette(Sul)

Package Instruction:

Each inner box has 30 servings, Volume: 15.5*11*11CM, Weight: 0.35KG

One outer box contains 52 inner boxes, Volume: 65*40*45CM, Weight: 19.5KG

Packing: Paper, Plastic bag

Storage Temperature: 2°C- 30°C

Period of Validity: 12 Months

One-step Test Kit Features

1. Specifications: High sensitivity and specificity, Compared with PCR, Overall Agreement: 98.0%.

2. Fast: The entire testing process only takes 15-20 minutes.

3. Simple: Without any other equipment, the operation is very simple and easy to carry.

4. Flexible: Be asuitable for serum, plasma, wholeblood samples.

5. High stability: The reagent is stable and can be stored for a long time.

6. For professional in vitro diagnostic use only.

Specifications and Models

Name	Number	Packing unit
New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold)	30	Kit

Weight Volume

Unit	Piece	Volume(CM)	Weight(KG)
per box	30	15.51111	0.35
per carton	52*30	654045	19.5
per pallet	145230	120105135	273

The New Coronavirus COVID- 19 Antibody Detection Kit (Colloidal Gold) has been compared with a commercial EIA test, the results indicating high specificity and sensitivity:

lgG results:

- Relative Sensitivity: 93.0%

- Relative Specificity: 98.7%

- Accuracy: 98.1%

IgM results:

- Relative Sensitivity: 91.6%

- Relative Specificity: 98.9%

- Accuracy: 96.7%

How Do I Understand the Results?
The readout should show 1 line in the C (control) region. Purple lines may appear next to the G (IgG) and M (IgM) regions
depending on exposure to COVID-19. Faint lines are treated as a positive result.
C, G, and M regions are positive: user recently infected or re-infected with COVID-19.
C and G regions positive, M region negative: user previously infected with COVID-19.
C and M regions positive, G region negative: user recently infected with COVID-19 for the first time.
C region positive, G and M regions negative: user not showing immune response to COVID-19.
C region negative, G and M regions either positive or negative: test did not function correctly.

COVID-19 IgG IgM Rapid Test Kit

Assay Procedure of New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold)

Step 1: Bring the specimen and test components to room temperature, Mix the specimen well prior to assay once thawed.

Step 2: Open the foil pouch and remove test strip. Place the test strip on a clean, flat surface.

Step 3: Be sure to label the test strip with specimen ID number.

Step 4: 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.

Assay Procedure of New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold) (2)

Step 5: Read the result at 15-20 minutes. Positive results may be visible in as short as 1 minute. Don’t read result after 30 minutes. To avoid confusion, discard the test strip after interpreting the result.

Interpretation of Assay Result

1. Negative Result: If only the C line is present, the absence of any burgundy color in both test lines (G and M) indicates that no anti-novel coronavirus antibodies are detected. The result is negative or non-reactive.

2. Positive Result:

2.1 In addition to the presence of C line, if only the M line develops, the test result indicates that lgM anti- novel coronavirus is detected. The result is lgG anti- novel coronavirus positive or reactive.

2.1

2.2 In addition to the presence of C line, if only the M line develops, the test result indicates that lgG anti- novel coronavirus is detected. The result is IgG anti- novel coronavirus positive or reactive.

2.2

2.3 In addition to the presence of C line, if both G and M lines develop, the test result indicates that lgG and IgM anti-novel coronavirus are detected. The result is lgG and IgM anti- novel coronavirus positive or reactive.

Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a diagnosis is made.

3. Invalid: If no C line develops, the assay is invalid regardless of any burgundy color in the test lines (G and M) as indicated below. Repeat the assay with a new device.

2.3

New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold) Operating Instruction

New Coronavirus COVID-19 Antibody Detection Kit (Colloidal Gold)

Hunan Runmei Gene Technology Co.,LTD

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