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Uncut sheet Strips
Uncut sheet Strips
Uncut sheet Strips
Uncut sheet Strips

Uncut sheet Strips

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.

  • Product Description
  • Specification
  • Private Label Service

1. Technical Specifications

 

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.

 

 

2. 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, 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

 

3. 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 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

Lateral Flow Assay Private Label Service

Bring your own branded product into market within 2 weeks.

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.

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