COVID-19 antibody test uncut sheet

COVID-19 IgG IgM Uncut Sheet and Pre-cut Strips

COVID-19 Antibody Test Uncut Sheet

In March 2020, JOYSBIO was one of the first manufacturers who developed the 2019 novel coronavirus IgM/IgG antibody test kit for the qualitative detection of IgM and IgG antibodies against SARS-CoV-2. JOYSBIO now supplies the COVID-19 antibody test uncut sheet to help medical device suppliers quickly set up their own lateral flow assay manufacturing facilities to expand testing capacity during the pandemic.

Manufacturing from uncut sheets is the fastest way beside our lateral flow assay private label service to bring your own product to the market. With the uncut sheet, the production process only requires to cut the sheet and assemble a two-piece plastic cassette before packing into a pouch. Pre-cut strips are available at JOYSBIO.

Inquire today to learn more about our new product: COVID-19 Antigen (Ag) Rapid Test Uncut Sheet.

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Technical Specifications

Formulated with coronavirus N- and S-proteins, JOYSBIO’s COVID-19 antibody test uncut sheet features high sensitivity and specificity for both IgM and IgG antibodies. For the IgM antibody, sensitivity is 83.52%, and the specificity is 98.17%; For IgG antibody, sensitivity is 91.21%, and the specificity is 97.71%. JOYSBIO has been in the lateral flow assay manufacturing industry for over ten years and has established a reliable supplier network for high-quality raw materials to ensure the performance of its diagnostics products.

Formulated with High-Quality Antibodies and Antigens

The sensitivity and specificity of a COVID-19 antibody rapid test product highly depend on the raw materials used during uncut sheet production. Working in the lateral flow assay manufacturing industry for over ten years, JOYSBIO has established a reliable supply chain management system. The highest grade of antibodies and antigens are used for our COVID-19 antibody test uncut sheets. Please contact us for the certificates of analysis of each raw material.

Antigens and Antibodies Used

Species Purified From

Certificate of Analysis

Mouse anti-Human IgM antibody

Mouse

Available

Mouse anti-Human IgG Antibody

Mouse

Available

Goat anti-Chicken IgY Antibody

Goat

Available

Recombinant novel Coronavirus Antigen 

Escherichia Coli

Available

Chicken IgY Antibody

Egg

Available

lateral flow assay uncut sheet white background

Uncut Sheets

Lateral flow assay cassette assembly

Lateral Flow Test Cassette Assembly

Reasons to Choose COVID-19 Antibody Test Uncut Sheet

Compared with importing the finished lateral flow rapid test kit, the uncut sheet gives you a more significant profit margin, especially in the regions where labor costs are inexpensive. The uncut sheets also provide flexibility when facing time-consuming medical device custom inspections during the COVID-19 outbreak. 

The ready-to-use uncut sheet is already formulated with antibodies and antigens under JOYSBIO’s ISO 13485:2016 medical device quality management systems. Each sheet produces 80-90 lateral flow test cassette on average. The rapid test cassette production only requires the following steps:

  1. Cut sheet into strips (pre-cut strips are available)
  2. Assemble the rapid test kit with a two-piece cassette
  3. Pack cassettes into pouches and boxes

View uncut sheets for JOYSBIO’s complete product portfolio.