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AxivaNitrocellulose Lateral Flow Membrane for Immunodiagnostic Applications

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Nitrocellulose Lateral Flow Membranes are crucial components in lateral flow assays and are engineered for precision with respect to capillary flow rate and uniform thickness. These factors significantly impact the sensitivity, reproducibility, and reagent use within assays. Discrepancies in membrane thickness may adversely affect the signal clarity and sensitivity at test and control lines, along with manufacturing and performance outcomes. Axiva ensures membrane uniformity through a sophisticated in-house manufacturing and measurement system, guaranteeing rigorous specifications, which enhances assay performance reliability. The membranes are designed to bind proteins effectively at capture lines without unwanted non-specific binding, thus boosting assay sensitivity and clarity. Axiva's production facilities maintain rigorous environmental controls for a stable manufacturing process, which is crucial for the consistency and performance of this diagnostic tool.

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Nitrocellulose Membrane is the most important part of a lateral flow assay and require highly consistent measurements for capillary flow rate and thickness across the length and width. Variation in either can have detrimental effects on assay sensitivity, reproducibility, repeatability in results and reagent consumption (in special assay developments which are controlled by time or volume consumed). Signal generation at the test and control lines is influenced by the thickness of the reaction membrane. The variation in thickness across or down a roll can have negative effects in both the manufacturing in-process approval levels and final assay performance.

For maintaining the uniformity of membrane Axiva posses a complete in house developed manufacturing unit for membrane and well developed measuring techniques which ensure release of product with stringent specification and CV for the best performance under critical assay developing processes.

Established in year 2006, Axiva Sichem Pvt. Ltd. is engaged in manufacturing & exporting a wide range of Diagnostic products like
1. Nitrocellulose Lateral Flow Membrane
2. Sample Pad (Glass Fibre)
3. Conjugate Pad (Polyester Pad)
4. Absorbent Pad (Cellulose Fibre)
5. Membrane Filters

Good Quality’s that increase the assay reproducibility and sensitivity of membrane

Strong Consistency – Membrane provides high sensitivity and low background in diagnostic assays due to its consistent nature.

Increased sensitivity – Provides high sensitivity with dilute concentrations of target analytes with no false signals

Clear results – Demonstrates low background levels which enable crisp capture lines and easy-to-read results.

Dependable performance – Constructed of pure nitrocellulose that does not contain interfering substances or post-treatments that affect assay performance.

How to select nitrocellulose lateral flow membrane?
Selection of LFT membrane depends upon assay.Highest sensitivity is obtained with smaller size and slower wicking time/capillary flow time.Axiva offer wide range of Nitrocellulose lateral flow membrane to meet the requirement of different tests.

The Team
A group of skilled scientists, technicians, production workers and management are contributing their ability in a team work for developing a membrane technology for Lateral Flow Assay Test.

The Application Lab
Our diagnostic membrane application lab is fully equipped with instruments and material that enable us to characterize diagnostic membrane. To evaluate for Lateral Flow Test almost common chemistries and parameters are used in production and in laboratory.

Manufacturing Facilities
Axiva using a complete clean room in-house production facility well equipped with instruments. We have rigid environmental controls in place to produce a stable and clean manufacturing process. Complete area is class 100000, GMP compliant.

Membrane Manufacturing Process
The solution mixing and casting processes are designed and controlled to provide outstanding inter and intra-lot consistency. AXIVA owns clean-room facility for production of membrane which ensures a dust free smooth membrane surface.

Physical Testing
Capillary wicking timeis simple and highly informative test. 50μl of normal saline solution dropped at one edge of membrane strip and it wicks towards an open edge. Time taken to reach a fixed distance is called wicking time in seconds. Axiva membranes are characterised and differentiated by measurements of Wicking times of well planned samples and pore size comparisons with microscope. So we have traceable, repeatable and consistent quality products with well defined wicking times in seconds with isotonic normal saline solution. Signal generation at the time of test, control lines and tensile strength are largely influenced by the thickness of the reaction membrane. The variation in thickness across or down a roll can have negative effects in both the manufacturing environment and final assay performance. For maintaining the uniformity of membrane Axiva posses a complete in-house manufacturing for membrane and measurements are highly controlled with specification and CV for the critical parameters of membrane.

Functional Properties
Protein binding is a critical aspect of Nitrocellulose Membrane performance. To achieve optimum assay results, the membrane must bind sufficient proteins at the capture lines but not non-specifically bind the target analytes in the sample. Assay reproducibility is facilitated by consistent levels of protein binding which translates to achieving the desired amount of antibody binding at the capture lines. If there is variability in protein binding at the capture lines, the assay sensitivity and crispness of the capture line can be compromised. Axiva produces a uniform and good binding membrane that better for assay testing.

Consistent Wettability
Although cellulose nitrate polymers are naturally hydrophobic, Axiva use specific surfactant for treatment, to get a long time uniform wetting property of membranes. Also stability studies are done over a period of time on the basis of accelerated heat stability test Data of storage at normal storage conditions