Stain reagent

staining solutionsolutiondye

Description
Reticolor is an IVD vital staining solution for reticulocyte counting in peripheral blood, manufactured by Pro-Eko Srl as an in vitro diagnostic medical device (IVD). It highlights residual RNA in immature red blood cells using vital dyes (Brilliant Cresyl Blue - BCB or New Methylene Blue - NMB) which precipitate RNA into granular or filamentous structures colored blue-violet. The solution is ready-to-use and supplied as a colored liquid to be mixed with whole blood.

Indications for use
Solution for direct vital staining of reticulocytes, useful for differential diagnosis of anemias and for monitoring erythropoiesis.

Procedure for use

• In an appropriate tube, mix 2 drops of whole blood (EDTA) with 2 drops of Reticolor.
• Mix gently and incubate at room temperature for 15–20 minutes.
• Prepare a thin smear on a glass slide.
• Air-dry without fixation (vital staining).
• Examine under a light microscope at 100× (oil immersion).
• Count at least 1,000 red blood cells and record the number of reticulocytes (cells with blue-violet granules/reticulum).
• Calculate percentage: (number of reticulocytes / 1,000 RBC) × 100.

Technical characteristics (table)

• Type: Vital stain for reticulocytes (BCB or NMB)
• Color in solution: blue-azure
• Structures highlighted: residual RNA reticulum – blue granules and filaments in reticulocytes
• Mature erythrocytes appearance: not stained (pale grey-green appearance)
• Product type: In vitro diagnostic medical device (IVD)
• Use: direct vital staining (blood + stain mixture)
• Storage: 15–25°C, protected from light

Purpose of reticulocyte counting

• Differential diagnosis of anemias: distinguishes hypoproliferative from regenerative anemias.
• Therapy monitoring: evaluation of response to iron, B12, erythropoietin.
• Assessment of bone marrow function, e.g., during chemotherapy or after bone marrow transplant.
• Neonatal screening: evaluation of erythropoiesis in newborns.

Fields of application

• Clinical hematology: manual reticulocyte counting for assessment of erythropoiesis.
• Anemia diagnostics: support for differential diagnosis (iron-deficiency, megaloblastic, hemolytic, aplastic).
• Oncology: bone marrow monitoring during cytotoxic treatments and transplants.
• Nephrology: monitoring erythropoietic response in patients on EPO therapy.
• Teaching laboratories: demonstration slides for erythrocyte morphology.

IVD compliance and safety
The product is classified as an in vitro diagnostic medical device (IVD) under Regulation (EU) 2017/746 (IVDR). Management complies with REACH and CLP regulations. Consult the SDS for safety instructions of the dye (SDS not included in this datasheet).

Customization and contract manufacturing
The manufacturer produces Reticolor in custom formats for hematology laboratories; various packaging volumes and IVD documentation for accredited facilities are available.

FAQ - Frequently asked questions

• What is a reticulocyte? — An immature red blood cell recently released from the bone marrow that retains ribosomal RNA traces visible with vital stains.
• Why is reticulocyte count important? — It assesses bone marrow erythropoietic activity and monitors response to therapy.
• Can capillary blood be used? — Standard protocol uses venous EDTA blood; capillary blood is acceptable in pediatrics following the same proportions.
• What is the optimal incubation time? — 15–20 minutes at room temperature.

Characteristics / Technical specifications

• Commercial name: Reticolor
• Type: Vital stain for reticulocytes (BCB or NMB)
• Color in solution: blue-azure
• Structures highlighted: residual RNA reticulum (blue-violet granules and filaments)
• Use: mix 2 drops blood (EDTA) + 2 drops stain; incubate 15–20 min; observe at 100× oil immersion
• Storage: 15–25°C, protected from light
• Available formats: 100 ml; 4×100 ml
• Weight (product attribute): 2 kg
• Variant weight 100 ml (declared): 0.2 kg
• Variant weight 4×100 ml (declared): 0.8 kg
• Detected variant SKUs: EM1902 (100 ml), EM1902.4 (4×100 ml)
• Regulatory classification: In vitro diagnostic medical device (IVD) according to IVDR