Volume control test strip and methods of making and using the same

A method of at-home hemoglobin A1c (HbA1c) testing, the method comprising the following steps:

• a) pricking a finger of a subject to produce a finger-prick blood droplet;
• b) contacting the finger-prick blood droplet to a blood droplet engagement end of a HbA1c test strip or test kit;
• c) measuring a signal from a location having the HbA1c having boronic acid dye bound thereto;
• and
• d) generating a report including a HbA1c concentration from the blood based on the signal measured in step c).

A method of making a test strip, the method comprising:

• a) assembling a layered structure including:
• a base layer;
• a sample pad and optional dye separation layer positioned atop the base layer, the sample pad and optional dye separation layer comprising a sample pad and optionally a dye separation material;
• optional spacer layers and optional spacers within the other layers;
• a defined blood volume provision layer positioned atop the sample pad and dye separation layer, the defined blood volume provision layer comprising a plurality of defined blood volume provision channels each having a blood droplet engagement end and a terminal end, wherein the blood droplet engagement end has a sealed engagement opening, wherein the terminal end has a terminal opening at a bottom surface of the defined blood volume provision channel;
• and a top layer positioned atop the defined blood volume provision layer;
• and
• b) cutting the layered structure into individual test strips, wherein each individual test strip includes at least one defined blood volume provision channel.