Description
Unit: 1 Box (20 Tests)
Regulatory Status: CLIA Waived (whole blood) / Moderately Complex (serum / plasma) / Professional Use Only
Contents: (20) Reaction Unit, (20) Sample Pipette, (20) Capillary Tube, (1) Developer (5 ml), (1) Mono Positive Control, (1) Mono Negative Control, (1) Package Insert, (1) Procedure Card
Determinations: Qualitative Infectious Mononucleosis
Storage Requirements: 59° – 86° F
Processing Time: 5 Minutes
The QuickVue+ Infectious Mononucleosis Test is a precise, convenient immunoassay that offers a qualitative detection of Infectious Mononucleosis IgM heterophile antibodies in 5 minutes. Infectious Mononucleosis, often called “Mono” or “the kissing disease,” is a highly contagious viral infection most frequently caused by the Epstein-Barr virus (EBV). Mono infections are most common in those between the ages of 5 and 25 with the highest occurrence rates among teenagers and young adults. Symptoms can range from common complaints such as headaches, malaise, and sore throat to more serious complications such as tonsillitis, splenomegaly, and jaundice. Testing for Infectious Mononucleosis can be a valuable diagnostic tool, allowing parents and doctors to begin supportive care at earlier stages, lessening the severity of the illness and potential for life-threatening complications.
QuickVue+ Infectious Mononucleosis Test:
20 Reaction Units
20 Sample Pipettes
20 Capillary Tubes
1 vial (5 mL) Developer
1 Mono Negative Control (1 mL)
1 Mono Positive Control (1 mL)
1 Package Insert
1 Procedure Card
Key Features:
- Fast – Results in 5 minutes.
- Convenient – Multiple Sample Options: Whole Blood, Serum, or Plasma
- Easy-to Read – Qualitative plus/minus (+/-) endpoint results
- Accurate – 99% Sensitivity; 99% Specificity
- Dependable Performance – Includes both Internal & External Controls to insure compliance and confidence in results
- Long Shelf Life – 24 months from date of manufacture
- No special storage or shipping required – Stable at Room Temperature (59-86 degrees F)
- CLIA Waived – Whole Blood
About Infectious Mononucleosis
Infectious Mononucleosis is caused by the Epstein-Barr virus (EBV), a member of the Herpesviridae family, genus Lymphocryptovirus. The Epstein-Barr virus is a double-stranded, linear, DNA virus that infects the squamous epithelial cells and B lymphocytes in the immune system. Once infected, the individual becomes a lifelong carrier of a low grade infection which is kept in check by the body’s immune defenses. It is estimated that 90% to 95% of the adult population has been exposed to the EBV infection, though not all individuals experience symptoms of the illness. Infectious Mononucleosis is commonly referred to as “Mono” or “the kissing disease” since it is primary transmitted through saliva. EBV has also been found to spread through blood and genital secretions as well.
Virus replication begins in the epithelial cells in the pharynx, causing pharyngitis. The infection then moves to the B lymphocytes, triggering cytotoxic T cells to react against the EBV-infected B cells, producing lymphadenopathy (enlargement of the lymph nodes). These symptoms are often accompanied by fever, malaise, headaches, stiff neck, sweating, chills, rash, and abdominal discomfort and usually develop 4 to 6 weeks after initial exposure. Rare but serious complications may occur that require urgent evaluation or hospitalization. These include tonsillitis, jaundice, anemia, seizures, difficulty breathing or swallowing due to pharyngeal and tracheal obstruction, splenomegaly (leading to possible splenic rupture), meningitis, encephalitis, and Guillain-Barre syndrome.
There is no cure for Infectious Mononucleosis. Mono is characteristically a benign, self-limiting disease which resolves without medical support. Symptoms gradually diminish but may linger for weeks or even months. Supportive care is recommended, such as limiting activity (avoid strenuous exercise and contact sports), getting plenty of rest, hydration, throat lozenges, and over-the-counter medications to relieve symptoms.
The Mononucleosis infection is clinically similar to other illnesses such as acute cytomegalovirus infection, streptococcal pharyngitis, and Toxoplasma gondii. Diagnosis by a health-care provider is important to insure that the illness is not caused by other medical conditions that could require more extensive medical attention and treatment. The QuickVue+ Infectious Mononucleosis Test is an efficient, reliable tool for providing rapid testing; an accurate, definitive diagnosis; and allowing doctors to provide improved patient care and symptom management all in one visit.
