Description
Status Mono 84W10 84W30 Package Insert
Unit: 1 Box (25 Tests)
Regulatory Status: CLIA Waived (whole blood) / Moderately Complex (serum / plasma) / Professional Use Only
Contents: (25) Test devices, (25) Transfer Pipettes, (1) Developer Solution, (1) Mono Positive Control, (1) Mono Negative Control, (1) Package Insert, (1) Procedure Card
Determinations: Qualitative Infectious Mononucleosis
Storage Requirements: 36° – 86° F
Processing Time: 8 Minutes
Status Mono
For The Qualitative Detection Of Infectious Mononucleosis Heterophile Antibodies In Whole Blood, Serum Or Plasma
- CLIA WAIVED for whole blood
- FDA cleared with no age restrictions
- Single reagent procedure provides results in 3-8 minutes
- Fingerstick whole blood convenience
- Superior 99.9% sensitivity for earlier IM detection, specificity of 98.8%
- Multiple kit sizes available, ideal for any practice
- External QC negative and positive controls included (item # 68364 & 84M30)
- New plastic sample transfer pipettes
Status Mono one-step antibody test for IM uses direct solid-phase immunoassay technology for the qualitative detection of IM heterophile antibodies in human serum, plasma or whole blood. In the test procedure, 10 µl serum or plasma are added in the Sample Well (S) located below the result window. For finger-tip or whole blood, 25 µl of blood are collected in
a sample transfer pipette and spotted in the Sample Well (S). If any IM-specific heterophile antibody is present in the sample, it will be captured by the antigen band (bovine erythrocyte extracts) impregnated in the test membrane.
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.
