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Publication Number

US-10077476-B2

Patent

Publication Date

2018-09-18

Expiration Date


Abstract

A process and molecular biomarker for platelets stored in blood banks provides for efficient verification of which platelet concentrate bags are in good condition for transfusion by measuring, by real-time polymerase chain reaction, expression levels of hsa-miR-127 and hsa-miR-320a microRNAs as the first process and biomarker predictor of platelet's cell aging during storage and the consequent presence of storage lesions as a quality test of these bags.

Core Innovation

A molecular biomarker quality test is provided for stored platelet concentrate bags in blood banks to determine suitability of the stored, concentrated platelets for donation. The test isolates hsa-miR-127 and hsa-miR-320a microRNAs from a sample of the stored platelets in a small bag sample, and the isolated microRNAs are quantified by measuring an expression of the isolated hsa-miR-127 and the isolated hsa-miR-320a using real-time polymerase chain reaction (real-time PCR).

Based on the measurements, a ratio of the hsa-miR-127 and the hsa-miR-320a microRNAs (mir127/320a relation) is determined to predict platelet cell aging/storage lesions. Stored concentrated platelets are assessed using the biomarker relationship to reflect the platelet cell aging process. The approach uses hsa-miR-127 expression relative to hsa-miR-320a expression as the decision basis.

When the expression of hsa-miR-127 is equal to or more than the expression of hsa-miR-320a, the platelets are employed for transfusion. When the expression of hsa-miR-127 is less than the expression of hsa-miR-320a, the platelets are discarded. The described use of the hsa-miR-127/hsa-miR-320a relationship is stated to improve patient safety and reduce waste versus current time-based discarding.

Claims Coverage

The document provides one independent claim. The inventive features focus on using hsa-miR-127 and hsa-miR-320a microRNA measurements by real-time PCR, determining an expression ratio, and making a transfusion/discard decision based on a comparison of the two microRNA expression levels.

Biomarker-based suitability determination using hsa-miR-127 and hsa-miR-320a

Isolating hsa-miR-127 and hsa-miR-320a microRNAs from a sample of the stored, concentrated platelets, measuring an expression of the isolated hsa-miR-127 and the isolated hsa-miR-320a microRNAs using real-time polymerase chain reaction, and determining a ratio of the hsa-miR-127 and the hsa-miR-320a microRNAs based on said measurements.

Transfusion versus discarding decision based on relative microRNA expression

Employing the platelets for transfusion when the expression of hsa-miR-127 is determined to be equal to or more than the expression of hsa-miR-320a, and discarding the platelets when the expression of hsa-miR-127 is determined to be less than the expression of hsa-miR-320a.

Across the single independent claim, the suitability decision for stored, concentrated platelets is determined by isolating and real-time PCR measuring hsa-miR-127 and hsa-miR-320a microRNAs, determining a ratio based on the measurements, and comparing hsa-miR-127 expression to hsa-miR-320a expression to select transfusion or discarding.

Stated Advantages

Improve patient safety.

Reduce waste versus current time-based discarding.

Documented Applications

Determining the suitability of stored, concentrated platelets for donation from stored platelet concentrate bags in blood banks by predicting platelet cell aging/storage lesions.

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