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In March 2020, BONE 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. BONE 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 BONE. Inquire today to learn more about our new product: COVID-19 Antigen (Ag) Rapid Test Uncut Sheet.
Formulated with coronavirus N- and S-proteins, BONE’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%. BONE 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.
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, BONE 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 |
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 BONE’s ISO 13485:2016 medical device quality management systems. Each sheet produces 80-90 lateral flow test cassettes on average. The rapid test cassette production only requires the following steps:
◎Cut sheet into strips (pre-cut strips are available)
◎Assemble the rapid test kit with a two-piece cassette
◎Pack cassettes into pouches and boxes
Product Name | Detection |
Myoglobin/Creatine Kinase MB/Cardiac Troponin I Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
Cardiac Troponin I Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
Creatine Kinase MB Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
Myoglobin Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
Fecal Occult Blood Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Human Chorionic Gonadotrophin Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Luteinizing Hormone Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Treponema Pallidum Antibody Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Hepatitis B Virus Surface Antigen Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Hepatitis B Virus Surface Antibody Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Hepatitis C Virus Antibody Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Tuberculosis Antibody Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Mycoplasma Pneumonia IgM Antibody Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Chlamydia pneumonia IgM Antibody Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
HIV 1/2 Antibody Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Methamphetamine Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Morphine Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Ketamine Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Morphine/Methamphetamine/Ketamine Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
HIV1/2 Antibody in Human Oral Mucosal Exudate Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Helicobacter Pylori (HP) Antibody Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Helicobacter Pylori (HP) Antigen Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Procalcitonin (PCT) Quantitative Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
C-reactive Protein (CRP) Quantitative Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
D-Dimer Quantitative Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
N-terminal pro b-type Natriuretic Peptide (NT-ProBNP) Quantitative Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
Brain Natriuretic Peptide (BNP) Quantitative Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
Heart-type Fatty Acid Binding Protein (H-FABP) Quantitative Test Kit (Colloidal Gold) Uncut Sheet/Strip | Quantitative |
Hepatitis B (HBV) Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
Influenza A & B Antigen Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
COVID-19 IgM/IgG Rapid Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Uncut Sheet/Strip | Qualitative |
BONE offers industry-leading lateral flow assays for the detection of cardiac markers, cancer markers, infectious diseases, fertility, and drug of abuse. Our complete lateral flow assay product lines are available for private label or OEM.
"We take care of the production; you focus on the marketing.” BONE understands your urgency of brining high-quality lateral flow test cassettes to the market. With our expertise in specification development, manufacturing, quality control, supply chain management, and fulfillment, we are your trustworthy production partner so that you can allocate all your resources on sales and marketing.
BONE now provides private labeling service for the SARS-COV-2 rapid test kit and Monkeypox rapid test kit.
1. Customizable Components
We provide unique flexibilities to fulfill your lateral flow assay private labeling and OEM needs, here is a list of items available for private labeling and customization:
◎ Cassette – Cassette style and logo
◎ Pouch – Pouch design and logo
◎ Box – Box design and packaging
◎ Product insert (IFU) – printed with your own content
◎ Carton – Carton design and specification
2. One-Stop Lateral Flow Assay Private Label or OEM
BONE offers a one-stop private label or OEM service for lateral flow assays. Let us know the products you would like to distribute, and we will handle all the production and logistic works. Our services include:
◎ Specification Development
◎ Label/Box Design and Printing
◎ Amazon FBA Optimized Packaging Design
◎ Manufacturing
◎ Validation and Evaluation
◎ Quality Control
◎ Packaging
◎ Fulfillment Service
◎ CE and FDA Medical Device Registration
◎ Documentation for Local Importation Registration
3.Expand Testing Capacity During COVID-19
BONE supplies CE certified COVID-19 antibody rapid test kit to more than 30 countries. We understand the critical importance of bringing your product to the market quickly during the pandemic. The COVID-19 antibody rapid test kit private label services provide you with the fastest approach to commercialize your own product and contribute to the COVID-19 outbreak. To speed up and ease the private labeling process, BONE requires no additional charge for putting your own logo on the product pouch and boxes.