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

20 tests/box, includes:
20 Test Cassettes, 20 Desiccant Bags, 1 Dilution Buffer
Lancets (upon request), Droppers (upon request)

COVID-19 Antibody Test Kit

As a leading lateral flow test kits manufacturer in China, JOYSBIO 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. For rapid detection of active infection, learn more about the new COVID-19 rapid antigen test kit.

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
GET A QUOTE

 

Production Environment and Capacity

JOYSBIO implemented the quality management system from China Food and Drug Administration and obtained ISO9001, ISO13485 QMS certification, and CE 0197 from TÜV Rheinland LGA Products GmbH. 

Currently, JOYSBIO produces more than 500,000 test cassettes per day to supply healthcare workers in the global pandemic.

CE Certified

CE CERTIFIED

ISO 13485

ISO 13485

Production - JOYSBIO Lateral Flow Rapid Test Kit 1

PERFORMANCE CHARACTERISTICS

JOYSBIO has validated the COVID-19 IgG/IgM Test Kit by a clinical trial with a total of 400 clinical samples from individual patients: 367 serum samples, and 33 plasma samples (EDTA, heparin, and citrate). The study was performed at provincial hospitals in China from January to April 2020.

Across all study sites, serum and plasma samples from 182 COVID-19 patients with positive Real-Time RT-PCR results, and 218 patients with negative Real-Time RT-PCR results. The evaluation results are shown in the tables below. The sensitivity and specificity of JOYSBIO’s COVID-19 antibody test kit are confirmed to meet diagnosis standards.

  • Overall Positive Percent Agreement (Sensitivity, PPA) = 170/182 (93.41%)
  • Overall Negative Percent Agreement (Specificity, NPA) = 209/218 (95.87%)
  • IgM Sensitivity = 152/182 (83.52%), Specificity = 214/218 (98.17%)
  • IgG Sensitivity = 166/182 (91.21%), Specificity = 213/218 (97.71%)
COVID-19 Antibody Test Clinical Evaluation Overall Clinical Agreement

Performance Characteristics Overview

COVID-19 Antibody Test Clinical Evaluation IgG Report

Performance Characteristics- IgG

COVID-19 Antibody Test Clinical Evaluation IgM Report

Performance Characteristics- IgM

Lateral Flow Test Principle

JOYSBIO’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 IgM IgG antibody test kit principle

COVID-19 Antibody Test Kit Principle

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.
COVID-19 IgM IgG antibody test kit test operating procedure

Operation Procedure

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.

  • 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.
  • 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.
  • 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.
  • 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.

 

COVID-19 IgM IgG antibody test kit result interpretation

Interpretation of Result

FREQUENTLY ASKED QUESTIONS

Is the COVID-19 IgG IgM Antibody Test Kit approved by US FDA?
  1. This test has not been reviewed by the FDA.
  2. Negative results do not preclude acute SARS-CoV-2 infection. If an acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  3. Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  4. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
What is COVID-19 IgM IgG Rapid Test?

This test is a qualitative lateral flow assay cassette that can be used as point of care testing. This test can be used with whole blood, fingertip blood, serum and plasma samples to detect IgM and IgG antibodies against SARS-CoV-2. 

How does the COVID-19 antibody test compare to PCR test?

A Real-Time RT-PCR test (molecular diagnosis, or virus test) for COVID-19 detects the presence of 2019 novel coronavirus in patient samples, while the rapid test detects IgM and IgG antibodies against SARS-CoV-2. A combination of different available testing methods is recommended for diagnosis of COVID-19 infection. Other testing methods such as imaging can also be utilized.

Is this kit certified?

JOYSBIO’s COVID-19 IgG/IgM Rapid Test Kit is manufactured under ISO 13485 QMS. The test kit is CE certified and FDA EUA pending. 

What should I do if I am tested positive with the antibody rapid test kit?

The COVID-19 IgM/IgG antibody rapid test, or serology test cannot be used as a sole basis diagnosis method for the 2019 novel coronavirus. Positive result needs further confirmation by molecular test (Real-Time RT-PCR), and negative result does not rule out SARS-CoV-2 infection.

What's the availability or lead time of this product?

JOYSBIO’s production capacity of the COVID-19 IgM/IgG Rapid Test Cassette is 500,000 tests per week, please contact to check current lead time. We also supply uncut sheet.

What are the symptoms of COVID-19?‎
Symptoms may appear in 2-14 days after exposure to the SARS-CoV-2. Common symptoms includes: fever, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea. If you have any of these symptoms, please contact your local hospital or physician immediately.