Method and apparatus for the collection, storage, and real time analysis of blood and other bodily fluids

The present invention provides a simple, portable, relatively inexpensive apparatus for accurately and efficiently collecting, separating, testing, and even storing between about 1-20 ml, preferably about 1-10 ml, of blood or other bodily fluid in situ. The apparatus includes a collection chamber bounded on its sides by an opening in a sheet of material, preferably clear plastic, abutting a filter card. The filter card is made of fibrous material, preferably less than about a millimeter thick, having an average pore size of less than about 3 microns. Preferably, the fibers are glass and the fibrous material has an average pore size of about 1 micron. The fibrous material is treated with a carbohydrate/protein mixture which contains between about 1-40 percent wt/vol carbohydrate and about 0.1-15 percent wt/vol nonspecific protein, preferably between about 10-20 percent carbohydrate and about 5-8 percent protein. A preferred carbohydrate/protein mixture comprises about 10 percent mannitol and about 6 percent albumin. The blood or other fluid moves through the filter card by capillary action aided by an absorbent matrix with a high Klemm factor which abuts the filter card. The absorbent matrix and/or filter card can be treated with a wide spectrum of test reagents. The speed, cleanliness, and efficiency of the separation process can be altered by: (a) changing the absolute concentration of the carbohydrate/protein mixture; (b) applying positive or negative pressure to one side of the filter; and/or (c) varying the relative density and pore size of the filter card and absorbent matrix

Method and Apparatus for the Collection, Storage, and Real Time Analysis of Blood and Other Bodily Fluids

The present invention provides a method and apparatus for separating a blood sample having a volume of up to about 20 milliliters into cellular and acellular fractions. The apparatus includes a housing divided by a fibrous filter into a blood sample collection chamber having a volume of at least about 1 milliliter and a serum sample collection chamber. The fibrous filter has a pore size of less than about 3 microns, and is coated with a mixture including between about 1-40 wt/vol % mannitol and between about 0.1-15 wt/vol % of plasma fraction protein (or an animal or vegetable equivalent thereof). The coating causes the cellular fraction to be trapped by the small pores, leaving the cellular fraction intact on the fibrous filter while the acellular fraction passes through the filter for collection in unaltered form from the serum sample collection chamber

Method and Apparatus for the Collection Storage and Real Time Analysis of Blood and Other Bodily Fluids

The present invention provides an apparatus for separating a relatively large volume of blood into cellular and acellular fractions without the need for centrifugation. The apparatus comprises a housing divided by a fibrous filter into a blood sample collection chamber having a volume of at least about 1 milliliter and a serum sample collection chamber. The fibrous filter has a pore size of less than about 3 microns, and is coated with a mixture of mannitol and plasma fraction protein (or an animal or vegetable equivalent thereof). The coating causes the cellular fraction to be trapped by the small pores, leaving the cellular fraction intact on the fibrous filter while the acellular fraction passes through the filter for collection in unaltered form from the serum sample collection chamber

Whole Blood Cell Staining Device

An apparatus and method for staining particular cell markers is disclosed. The apparatus includes a flexible tube that is reversibly pinched into compartments with one or more clamps. Each compartment of the tube contains a separate reagent and is in selective fluid communication with adjoining compartments

A Randomized Clinical Trial to Evaluate Two Doses of an Intra-Articular Injection of LMWF-5A in Adults with Pain Due to Osteoarthritis of the Knee

<div><p>Objective</p><p>The Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A) is being investigated as a treatment for knee pain from osteoarthritis.</p><p>Methods</p><p>This was a multicenter randomized, vehicle-controlled, double-blind, parallel study designed to evaluate the safety and efficacy of two doses of an intra-articular injection of LMWF-5A. Patients with symptomatic knee osteoarthritis were randomized 1∶1∶1∶1 to receive a single 4 mL or 10 mL intra-articular knee injection of either LMWF-5A or vehicle control (saline). The primary efficacy endpoint was the difference between treatment groups in the Western Ontario and McMaster Universities (WOMAC) pain change from baseline over 12 weeks. Safety was examined as the incidence and severity of adverse events (AEs).</p><p>Results</p><p>A total of 329 patients were randomized and received treatment. LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control (−0.93 vs −0.72; estimated difference from control: −0.25, p = 0.004); an injection volume effect was not observed (p = 0.64). The effect of LMWF-5A on pain was even more pronounced in patients with severe knee OA (Kellgren Lawrence Grade IV): the estimated difference from control was −0.42 (p = 0.02). Adverse events were generally mild and were similar in patients who received vehicle control (47%) and LMWF-5A (41%).</p><p>Conclusions</p><p>This clinical trial demonstrated that LMWF-5A is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="http://clinicaltrials.gov/show/NCT01839331" target="_blank">NCT01839331</a></p></div

Summary of the percent improvement in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain subscore.

<p>Summary of the percent improvement in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain subscore.</p

Summary of Adverse Events (AEs).

<p>Summary of Adverse Events (AEs).</p

Summary of Additional Efficacy endpoints, reported as Mean Change (SE) at Week 12, ITT.

*<p>WOMAC, Western Ontario and McMaster Universities Osteoarthritis.</p><p>Control: Saline vehicle control; Index. PGA, Patient Global Assessment of disease severity; K-L, Kellgren-Lawrence.</p>†<p>P values were calculated using mixed-effects repeated measures ANCOVA, with adjustment for baseline score.</p

Demographics and baseline characteristics: ITT population.

<p>Control, saline vehicle control; BMI, Body Mass Index; K-L Grade, Kellgren Lawrence Grade; PGA, Patient Global Assessment; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.</p><p>The BMI is the weight in kilograms divided by the square of the height in meters. The PGA scores can range from 0 to 5. Scores for the WOMAC can range from 0 to 5.</p

Summary of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Mean Change in Pain (SE) over Time.

<p>Control: Saline vehicle control.</p>*<p>Data were collected at in-person clinic visits; data at all other Weeks were collected via telephone.</p>†<p>P values were calculated using ANCOVA, with adjustment for baseline WOMAC A pain score.</p