Description
The Clarity Mononucleosis Test Kit gives clinics a rapid heterophile antibody cassette for the mono workup, with developer solution and both controls in the box. The manufacturer reports 99 percent overall accuracy, and whole blood testing is CLIA waived for office based sites.
- Format – Rapid mononucleosis cassette test.
- Accuracy – 99 percent overall accuracy, as reported by the manufacturer.
- Specimens – Whole blood CLIA waived, plasma and serum at moderate complexity.
- Packaging – 15 test cassettes per box with controls and developer solution.
About This Mononucleosis Rapid Test
The mono workup usually starts with a tired teenager, a sore throat and a clinician deciding whether antibiotics or answers come first. This cassette tests for heterophile antibodies associated with infectious mononucleosis and returns a result during the visit. The manufacturer reports sensitivity above 99 percent and specificity of 98.6 percent, with 99 percent overall accuracy against its reference method.
Whole blood testing is CLIA waived, while plasma and serum run at moderate complexity for laboratory settings. The kit is made in the USA with 18 month dating, and there is no age restriction on the patient population.
Features and Benefits
Clinical Performance
- Reported accuracy – The manufacturer reports 99 percent overall accuracy, with sensitivity above 99 percent and specificity of 98.6 percent.
- No age restriction – The test can be used on children as well as adults, which fits family practice and pediatric offices.
Kit Contents
- Controls included – Positive and negative controls come in the box with the developer solution and sample transfer tubes.
- Complete bench kit – Fifteen cassettes, transfer tubes, insert and procedure card cover the full run without extra orders.
Product Specifications
Product Details
- Manufacturer: Clarity Diagnostics
- Test type: Rapid test for infectious mononucleosis (heterophile antibody)
- Specimens: Whole blood (CLIA waived), plasma or serum (moderate complexity)
- Overall accuracy: 99 percent (manufacturer reported)
- Sensitivity: Above 99 percent (manufacturer reported)
- Specificity: 98.6 percent (manufacturer reported)
- Origin: Made in the USA
- Shelf life: 18 month dating
Packaging
- Box contents: 15 test cassettes, developer solution, 15 sample transfer tubes, 1 positive control, 1 negative control, package insert, procedure card
- Sold as: 1 box of 15 tests
Browse related categories: infectious disease tests and Clarity Diagnostics products.
Why Choose the Mono Test with Controls in the Box
A mono result shapes antibiotic decisions and school or work notes, so offices need the answer during the visit. This kit carries its own controls and developer, which keeps the test self contained.
- Same visit answers – A rapid cassette result settles the mono question before the patient leaves, guiding antibiotics and activity advice.
- Documented quality – Included positive and negative controls let waived sites record quality runs from the same box.
- Broad patient fit – No age restriction means one kit serves pediatric, family practice and urgent care panels.
Manuals and Troubleshooting Guides
Frequently Asked Questions
What does this test detect?
The cassette detects heterophile antibodies associated with infectious mononucleosis. It supports the mono workup alongside the clinical picture.
Which specimens can be used?
Whole blood runs as a CLIA waived test, and plasma or serum run at moderate complexity. Pick the specimen path that matches your site certificate.
How accurate is the test?
The manufacturer reports 99 percent overall accuracy, sensitivity above 99 percent and specificity of 98.6 percent. Those figures come from the manufacturer evaluation of the assay.
What is included in the box?
The box holds 15 test cassettes, developer solution, 15 sample transfer tubes, positive and negative controls, the package insert and a procedure card. Nothing else is needed to run the test.
Is there an age limit for patients?
No, the manufacturer states there is no age restriction for this test. It can be used for children and adults.
