The Mono II Rapid Test is designed for the qualitative detection of infectious mononucleosis (IM) heterophile antibodies in serum, plasma, or whole blood. It serves as an aid in diagnosing infectious mononucleosis.

Infectious mononucleosis is caused by the Epstein-Barr Virus (EBV) and is characterized by symptoms such as fever, sore throat, and swollen lymph glands. It predominantly affects late adolescents aged 15-24. The laboratory diagnosis of IM relies on detecting IM heterophile antibodies, which react with antigens found in bovine, sheep, and horse erythrocytes. The Mono II Rapid Test uses an extract of bovine erythrocytes to ensure the required sensitivity and specificity.

Procedure of the Test

The Mono II Rapid Test employs color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. The procedure involves the following steps:

1. For fingertip blood: Dispense all of the blood from capillary tube. For serum, plasma, or whole blood samples in tubes: Add 1 drop.
2. Slowly add 1 drop of Diluent to the bottom of the Test Tube and Mix. .
3. Remove the Test Stick(s) from the container. Re-cap the container immediately. Place the Absorbent End of the Test Stick into the treated sample. Leave the Test Stick in the Test Tube.
4. Read results at 5 minutes. Positive results may be read as soon as the red Control Line appears

Features:

• Specimen Types: Can be used with serum, plasma, or whole blood.
• Detection: Identifies IM heterophile antibodies.
• Rapid Results: Provides quick and reliable results.
• High Sensitivity and Specificity: Utilizes bovine erythrocyte extract for accurate detection.
• Ease of Use: Simple procedure with minimal steps.

Clinical Relevance:

• Target Group: Late adolescents (15-24 years) with symptoms of infectious mononucleosis.
• Symptoms of IM: Fever, sore throat, and swollen lymph glands.
• Diagnosis Aid: Supports clinical diagnosis of infectious mononucleosis through antibody detection.

Kit Contents:

• 25 Test Sticks in a container
• 25 Test Tubes
• 25 Transfer Pipettes
• 25 Capillary Tubes with 1 Capillary Bulb
• 1 Diluent (contains buffer with 0.2% sodium azide)
• 1 Mono Positive Control (contains rabbit anti-beef stroma in tris buffer with 0.2% sodium azide and 0.05% gentamycin sulfate preservatives)
• 1 Mono Negative Control (contains goat albumin in tris buffer with 0.2% sodium azide)
• 1 Work Station
• 1 Directional Insert

Note: Extra components (tubes, pipettes, capillary tubes and capillary bulb) have been provided for your convenience.

Storage:

• Do not freeze.
• Store the Test Sticks and reagents tightly capped at 15°-30°C (59°-86°F).
• Do not use the Test Sticks or reagents after their expiration dates.

Warnings And Precautions:

• For in-vitro diagnostic use only.
• Follow your laboratory safety guidelines in the collection, handling, storage and disposal of patient specimens and all items exposed to patient specimens.
• The Diluent and Controls contain sodium azide which may react with lead or copper plumbing to form potentially explosive metal azide. Large quantities of water must be used to flush discarded Diluent or Controls down a sink.
• The Capillary Bulb contains dry natural rubber