Thickness

The thickness of the reaction membrane has a direct impact on its signal generation. Consequently, any variations both intra- or inter-lot will have an impact on Point of Care Test (POCT) device manufacturing and the final assay performance.

In the data drawn from 3 lots, measuring the thickness of the membrane every 2.5 cm down a sample piece of material, the coefficient of variation was measured as ≤4.6% for Vivid 120 LFNC membrane with average thickness for all sample points being 196.7 ± 8.1 μm (Graph 1) and for Vivid 90 LFNC membrane the coefficient of variation was ≤2.6% with average thickness for all sample points being 217.1 ±

Capillary Speed/Wicking

Assay sensitivity is maintained with consistency of the wicking rate of the nitrocellulose membrane. By maintaining a uniform sample front that travels along the membrane at a consistent speed, the target analyte is maintained in a homogenous concentration. This ensures that the target analyte present in the sample has adequate time to bind to the capture antibody resulting in reproducible results from lot to lot. The wicking rate of the Vivid 90 and Vivid 120 LFNC membranes both exhibit CV’s for intra- and inter-lot consistency of ≤ 10% (Table 2 and 3).

Table 2: Summary data of intrer-lot reproducibility (from three sample points) of capillary speed and inter-lot reproducibility across three lots.

Table 3: Summary data of intra-lot reproducibility (from three sample points) of capillary speed and inter-lot reproducibility across three lots.

Scanning Electron Microscopy

Removal of white blood cells to prevent interference with PCR or molecular diagnostics.

Removal of cellular components (red cells, white cell, platelets) in less than two minutes resulting in a supernatant with similar qualities to centrifuged material.

Pall Corporation and Diagnostics

Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The Company’s engineered products enable process and product innovation and minimize emissions and waste.

Our extensive portfolio of membrane and media products serve applications from diagnostics to venting, worker and equipment protection as well as Intravenous drug delivery.

Medical diagnostic teams need a reliable business partner with expertise in technology innovations and state of the art engineering. Pall executes manufacturing to ensure regulatory compliance and meet quality standards. Our diagnostic products are manufactured in accordance with ISO 9001.

Pall understands that the world of medical diagnostics gets more complicated every day. We know that you’re counting on our team to provide you with quality products, so that you can provide your patients with insight and resolution.