COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)

Overview

As a leading lateral flow test kits manufacturer in China, Huaree has developed and launched one of the world’s first point-of-care lateral flow rapid test cassettes for the diagnosis of 2019 novel coronavirus disease. The COVID-19 Antibody Rapid Test Kit (Colloidal Gold) is for in vitro qualitative determination of both IgG and IgM antibodies in human serum, plasma, and fingertip blood. Clinical laboratories or healthcare workers can use this product for laboratory or point-of-care testing. The COVID-19 antibody lateral flow test is a fast and effective method for the SARS-CoV-2 antibody screening of a large population.

Features

• Rapid detection within 15 mins

• Compatible with serum, plasma, whole blood, and fingertip blood

• Qualitative detection of both IgG and IgM antibodies

• Point of care (POC) testing with easy-to-read visual interpretation

Test Principle

Huaree’s COVID-19 IgG IgM Antibody Test Kit (Colloidal Gold) detects both Immunoglobulin G and Immunoglobulin M antibodies of 2019 novel coronavirus on a single test cassette.

When the test operator adds sample to loading well of a test strip, the sample flows through the blood filter film. If the test sample contains the COVID-19 IgM antibody, it can combine with colloidal gold-labeled novel coronavirus antigen to form a complex. The mouse anti-human IgM antibody coated on the test cassette (M line) can capture the complex and develop a red color band. If the SARS-CoV-2 IgG antibody is present in the test sample, it combines with colloidal gold-labeled novel coronavirus antigen to form another type of complex. After the complex moves towards another end of the test cassette by capillary force, it can be captured by the mouse anti-human IgG antibody coated on the G line of the test cassette. A quality control line (C line) is designed on the test kit to act as procedural control.

COVID-19 Antibody Rapid Test Procedure

1.  Move COVID-19 Antibody Rapid Test Kit and specimen to room temperature. Tear off the foil pouch and take out the test cassette. Place the test cassette on a clean and levelled surface.
2.  Add 20µL whole blood or 10µL serum (or plasma) to sample well.
3.  Add 70µL (or two drops) of diluent to sample well.
4.  Start the timer. The results can be observed at room temperature for 15-20 minutes
    

Interpretation of Test Results

The result of COVID-19 Antibody Rapid Test Kit should be read within 15~20 minutes after the sample and diluent are added into the sample loading well. The result displayed after 20 minutes is invalid.

1. IgM Positive: colored bands appeared on M line and C line in the reading window, which suggests the patient is positive for IgM antibody against SARS-CoV-2.

2. IgG Positive: colored bands appeared on G line and C line in the reading window, which suggests the patient is positive for IgG antibody against SARS-CoV-2.

3. Antibody Negative: only colored bands appeared on C line in the reading window, which suggests the patient is negative for either IgM or IgG antibody against SARS-CoV-2.

4. Invalid: there is no colored band at the position of C line in the reading window. The test is invalid regardless of whether there are colored bands in the M and G positions. Please repeat the test with a new test cassette.

Performance Characteristics

huaree tech coronavirus Ag test kit A total of 107 positive specimens were tested with huaree tech COVID-19 Antigen Rapid Test Kit. These specimens were collected from patients who are suspected of COVID-19 with nasal swabs. The coronavirus antigen test kit’s sensitivity and specificity are compared against a CE-IVD marked RT-PCR test kit. This clinical evaluation is conducted under the assumption that SARS-CoV is no longer spreading in the community. 

According to the clinical analysis of 492 samples, the detection sensitivity is 98.13%, and the specificity is 99.22%.

• Positive Percent Agreement (PPA) = 105/107 (98.13%) (95%CI: 93.4%~99.8%)
• Negative Percent Agreement (NPA) = 382/385 (99.22%) (95%CI:97.7%~99.8%)
• Accuracy = (105+382)/492×100%=98.98%
• Kappa = 2×(105×382-3×2)/(108×385+107 ×384) = 0.97＞0.5

The limit of detection (LOD) of this product is 1.6 x 10² TCID₅₀/mL, calculated through a gradient dilution method.

Related Scientific Publications

1. Five Antigen Tests for SARS-CoV-2: Virus Viability Matters
2. Lateral flow antigen tests can sensitively detect live cultured virus of the SARS-CoV-2 B1.1.7 lineage
3. Impaired performance of SARS-CoV-2 antigen-detecting rapid tests at elevated temperatures
4. Limited specificity of SARS-CoV-2 antigen-detecting rapid diagnostic tests at low temperatures

1. COVID-19 Antigen Rapid Test Principle The coronavirus antigen rapid test kit is a lateral flow assay that qualitatively detects the presence of nucleocapsid (N) protein in upper respiratory samples (nasal swabs). This lateral flow assay is designed with the sandwich immunoassay format. When the specimen is added onto the sample pad of a test cassette, coronavirus N protein binds with colloidal gold-labeled SARS-CoV-2 N protein antibody to form an antibody-antigen (Ab-Ag) complex. The Ab-Ag complex is captured by SARS-CoV-2 N protein antibody (Rabbit monoclonal antibody) when migrating to the test line under capillary action.
2. A red-colored band will appear on the test line, which indicates the specimen is COVID-19 nucleocapsid protein positive. No color band will appear on the test line if the specimen does not contain any coronavirus antigen (N protein), or the antigen level is below detection limit.
3. Coronavirus Antigen (Ag) Rapid Test Kit Principle The conjugation pad also contains colloidal gold-labeled chicken IgY, which is captured by Goat anti-chicken IgY on the control line as procedural control. A colored band on the control line represents the proper liquid flow through the cassette; the absence of a colored band on the control line indicates insufficient sample or buffer volume.

COVID-19 Antigen Test Procedure

1. Twist off the cap of the buffer bottle, carefully dispense all buffer into the extraction tube .

2. After collecting upper respiratory sample with nasal swab, insert the swab into the extraction tube, plunge the swab up and down in the fluid for a minimum of 10 seconds. Hold the swab against the bottom of the tube, rotate three turns. DO NOT splash liquid out of the tube.

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

4. Press the nozzle cap firmly onto the extraction tube. Mix thoroughly by swirling or flicking the bottom of the tube.

5. Gently squeeze the tube s rigid body, dispense two (2) drops of the buffer-specimen mixture into the sample well on the coronavirus antigen test cassette. Read the test results between 15 and 20 minutes. Do not read the results after 20 minutes. Please check Instructions for Use for complete procedure

Interpretation of Test Results

NEGATIVE: A colored band appears on the control line (C line); no colored band shows up on the test line (T line). A negative result indicates there is no coronavirus antigen (N protein) in the specimen, or the level of coronavirus antigen is below the detection limit.

POSITIVE: A colored band appears on the control line (C line), a second colored band shows up on the test line (T line). A positive result indicates the presence of COVID-19 antigen (N protein) in the patient sample.

INVALID: No colored band appears on the control line (C line). An invalid test result suggests there might be insufficient buffer volume or incorrect operating procedures. Carefully review the test procedure and test the same patient again with another coronavirus antigen rapid test cassette. Contact your distributor if the problem persists.

Coronavirus Antigen Test Kit FAQs

What is the difference between COVID-19 PCR test, antigen test, and antibody test?

There are two kinds of tests available for COVID-19: viral tests and antibody tests. RT-PCR test and antigen test are both viral test which detects the presence of SAR-CoV-2 from upper respiratory samples. The RT-PCR test targets the genomic information of the virus (RNA); however, the COVID-19 antigen test kit detects pieces of proteins that make up the SARS-CoV-2 virus. The WHO recommends both RT-PCR tests and antigen tests for the diagnosis of active coronavirus infection. Please visit the US FDA page for more information about Coronavirus Testing Basics.

Can I use this test at home for self-testing?

The COVID-19 antigen test kit is provided for use by clinical laboratories, to healthcare workers for point-of-care testing. This test kit can be used as home-test by lay person subject to local legislations. huaree tech Biotechnology is working on the submission of over-the-counter (OTC) permission. Please make sure to check with your local ministry of health or regulatory authorities before placing an order.

What's the availability of this product and how long can you deliver to my country?

This product is available now. For small quantities, delivery can be made within 1-2 weeks. Please contact us for large order quantities. Our international sales team is happy to assist you with large orders or distributor discounts.

Do you provide private label service or uncut sheet?

We provide private label service at a minimal cost ($0-0.2/test); Uncut sheet is available for all of our lateral flow rapid diagnostic kits. Please contact us for more information.