Product Overview
The Accutest® Rapid Mono Test is a one-step, direct solid-phase immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in human whole blood, serum or plasma. It is intended for use as an aid in the diagnosis of infectious mononucleosis.
The cassette-format test uses bovine erythrocyte extract and a monoclonal mouse anti-human IgM antibody-dye conjugate. Whole-blood testing requires 25 µL of specimen and is CLIA-waived. Serum or plasma testing requires 10 µL and is classified as non-waived. Add the specimen and developer solution, then read the result at 8 minutes. Do not interpret the test after 15 minutes.
For in vitro diagnostic use. Test results must be interpreted together with the patient’s clinical presentation and other available information.
8-Minute Results
Read the test at 8 minutes; do not interpret after 15 minutes.
CLIA-Waived Whole Blood
Supports fingerstick or anticoagulated whole-blood testing with a 25 µL sample.
25 Tests per Kit
Test devices, developer solution, positive and negative controls, and transfer pipettes are included.
Key Features
- Qualitative detection of infectious mononucleosis heterophile antibodies
- Compatible with fingerstick whole blood, anticoagulated venous whole blood, serum or plasma
- One-step, cassette-format solid-phase immunoassay
- Results read at 8 minutes
- Whole-blood testing is CLIA-waived
- Serum and plasma testing are non-waived
- 25 µL whole-blood specimen or 10 µL serum/plasma specimen
- Positive and negative external controls included
- Relative sensitivity >99.9% and relative specificity 98.8% in the package-insert comparison study
- Overall agreement of 99.0% across 576 specimens in the package-insert comparison study
- Storage at 2–30°C (36–86°F); do not freeze
- Catalog number ID516; 25 tests per kit
Rapid Mono Test Procedure
This overview does not replace the package insert. Bring the test device, reagents and specimen to room temperature and follow the current instructions supplied with the kit.
1. Prepare
Remove a test device from its sealed pouch and place it on a flat surface.
2. Add Specimen
Use the red-line pipette for 25 µL whole blood or the black-line pipette for 10 µL serum/plasma.
3. Add Developer
Add 2–3 drops of Developer Solution to the lower area of the sample well.
4. Read
Interpret the result at 8 minutes. Do not read the device after 15 minutes.
Product Specifications
| Catalog Number | ID516 |
|---|---|
| Product Name | Accutest® Rapid Mono Test |
| Test Type | One-step, direct solid-phase immunoassay |
| Detection | Qualitative detection of infectious mononucleosis heterophile antibodies |
| Specimen Types | Fingerstick whole blood, anticoagulated venous whole blood, serum or plasma |
| Sample Volume | 25 µL whole blood; 10 µL serum or plasma |
| Developer Solution | 2–3 drops per test |
| Result Time | Read at 8 minutes; do not interpret after 15 minutes |
| CLIA Complexity | Waived for whole blood; non-waived for serum and plasma |
| Comparative Performance | Relative sensitivity >99.9% (91/91); relative specificity 98.8% (479/485); overall agreement 99.0% (570/576) |
| Storage | 2–30°C (36–86°F) in the sealed pouch; do not freeze |
| CPT Codes | 86308QW for CLIA-waived whole-blood testing; 86308 for serum/plasma testing. Verify coding and payer requirements for each setting. |
| Package Size | 25 tests per kit |
| Regulatory Use | For in vitro diagnostic use |
Performance values are comparative results reported in the package insert. Review the complete study design, limitations and current labeling before use.
Kit Contents
Each ID516 kit provides 25 tests and the reagents, controls and transfer pipettes listed below.
Included With the Kit
- 25 Accutest® Rapid Mono test devices
- Developer Solution
- Positive Control
- Negative Control
- 25 black-line 10 µL transfer pipettes for serum/plasma
- 25 red-line 25 µL transfer pipettes for whole blood
- Package insert
- Procedure card
Required but Not Provided
- Lancet for fingerstick collection
- Timer
- Centrifuge capable of separating blood cells from plasma when plasma is prepared on site
- Appropriate specimen-collection supplies
- Personal protective equipment and biohazard-disposal supplies required by the testing facility
Specimen and Result Information
Whole Blood
Fingerstick blood may be tested using the 25 µL red-line transfer pipette. Anticoagulated venous whole blood collected with CPDA-1, heparin or EDTA may also be used. Refrigerate whole-blood specimens at 2–8°C when testing is delayed and use within 24 hours. Do not freeze and thaw whole blood.
Serum or Plasma
Use the 10 µL black-line transfer pipette. Refrigerate specimens at 2–8°C until testing. If serum or plasma will not be tested within 48 hours, store at or below −20°C and avoid repeated freeze-thaw cycles. Clarify specimens containing particulate material by centrifugation before testing.
Result Interpretation
A positive result displays both a control line and a test line. A negative result displays the control line without a distinct test line. The result is invalid when the control line does not appear. Any shade of pink-purple line at the test position is interpreted as positive when the control line is present.
Important Product Information
- The test provides a qualitative result and is intended as an aid in diagnosis. Interpret results with clinical findings and other laboratory information.
- A negative result does not exclude infectious mononucleosis. Detectable heterophile antibodies may not be present early in infection.
- Approximately 50% of children under 4 years of age with infectious mononucleosis may test negative for heterophile antibodies. EBV-specific testing may be helpful when clinically indicated.
- Heterophile antibodies may persist after the primary illness, and they may be associated with conditions other than infectious mononucleosis. Review the package insert for the complete limitations.
- Whole-blood testing is CLIA-waived. Serum and plasma testing are non-waived and must be performed under the applicable laboratory requirements.
- Do not use a device from an open, broken or damaged pouch. Do not use expired components or interchange reagents between kit lots.
- Kit reagents contain sodium azide. Handle and dispose of reagents according to the package insert and facility procedures.
- Handle all human specimens and blood-derived materials as potentially infectious.
- Review the complete current package insert before testing.
Documentation and Resources
Review the complete package insert before collecting specimens, running controls or testing patient samples.
Accutest Rapid Mono Package Insert Accutest Infectious Disease Brochure View Mononucleosis Testing ProductsFrequently Asked Questions
The test qualitatively detects infectious mononucleosis heterophile antibodies in whole blood, serum or plasma. It is intended for use as an aid in the diagnosis of infectious mononucleosis.
The package insert identifies fingerstick whole blood, anticoagulated venous whole blood, serum and plasma as compatible specimen types. Follow the specimen-collection and handling instructions for the selected matrix.
Use 25 µL of whole blood with the red-line transfer pipette or 10 µL of serum/plasma with the black-line transfer pipette supplied in the kit.
Read the result at 8 minutes. Do not interpret the device after 15 minutes.
Whole-blood testing is CLIA-waived. Serum and plasma testing are classified as non-waived. Laboratories should follow all requirements applicable to the specimen type and testing setting.
Yes. Each kit includes positive and negative controls. The device also includes internal procedural control features. Follow the package insert and the laboratory’s quality-control policy for control testing.
Store the kit at 2–30°C (36–86°F) in its sealed pouch. Do not freeze, and do not use components after the expiration date.
The result is invalid when a distinct control line does not appear. Review the procedure and repeat the test with a new device according to the package insert.
No. Heterophile antibodies may not yet be detectable early in infection, and some patients do not develop measurable heterophile-antibody levels. Interpret results with symptoms, clinical findings and other laboratory information.
The catalog number is ID516. Each kit contains 25 test devices along with developer solution, positive and negative controls, transfer pipettes, a package insert and a procedure card.
Ordering Information
To confirm availability or place an order, call Jant Pharmacal at 800.676.5565
| Catalog Number | Description | Unit of Measurement |
|---|---|---|
| ID516 | Accutest® Mononucleosis Rapid Test | 25 tests/box |
Kit includes test devices, developer solution, positive and negative controls, transfer pipettes, package insert and procedure card.