Accutest Mononucleosis Rapid Test (25 Tests/Kit)
$75.25
FDA 510(k) Cleared
8-Minute Results
25 Tests/Kit
25 tests per kit • $3.01 per test
The Accutest Rapid Mono Test is a professional immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma. It is intended as an aid in the diagnosis of infectious mononucleosis.
- CLIA-waived for fingerstick or venous whole blood
- Serum and plasma testing is non-waived/moderate-complexity
- Read results at 8 minutes; do not read after 15 minutes
- Includes positive and negative external controls
- Includes separate sample-transfer pipettes for whole blood and serum/plasma
| 1-5 | 6-10 | 11+ |
| $75.25 | $69.23 | $65.47 |
Accutest Rapid Mono Test Overview
The Accutest Rapid Mono Test is a one-step, rapid visual immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in human fingerstick whole blood, venous whole blood, serum or plasma. It is intended for professional in-vitro diagnostic use as an aid in the diagnosis of infectious mononucleosis.
The whole-blood procedure is CLIA-waived. Serum and plasma testing is non-waived/moderate-complexity. Results are read at 8 minutes, and the 25-test kit includes developer solution, positive and negative controls, and specimen-specific sample-transfer pipettes.
FDA 510(k) Cleared
8-Minute Results
25 Tests per Kit
Features and Benefits
Qualitatively detects infectious mononucleosis heterophile antibodies
Accepts fingerstick whole blood, venous whole blood, serum and plasma
CLIA-waived when performed with whole blood according to the package insert
Provides an easy-to-read cassette result at 8 minutes
Positive and negative external controls are included for quality-control testing
Stores at 36-86°F (2-30°C) without freezing
Product Details
ID516
DTK-101502
25 Tests per Kit
Professional In-Vitro Diagnostic Use
Technical Specifications
| Specification | Details |
|---|---|
| Test method | One-step rapid visual solid-phase immunoassay |
| Analyte | Infectious mononucleosis heterophile antibodies |
| Specimens | Fingerstick whole blood, venous whole blood, serum or plasma |
| Sample volume | 25 µL whole blood; 10 µL serum or plasma |
| Result time | Read at 8 minutes; do not read after 15 minutes |
| Format | Visual test cassette |
| Regulatory status | FDA 510(k) cleared, K961024; CLIA-waived for whole blood |
| Serum/plasma complexity | Non-waived/moderate-complexity |
| Manufacturer-listed CPT codes | 86308QW for CLIA-waived whole blood; 86308 for serum/plasma |
| Age labeling | Manufacturer brochure states no age restrictions; see the pediatric limitation below |
| Storage | 36-86°F (2-30°C) in sealed pouches; do not freeze |
| Package size | 25 tests per kit |
CPT codes are manufacturer-listed references and do not guarantee coverage or reimbursement. Verify current coding requirements with the applicable payer before billing.
Kit Contents
25 individually pouched Accutest Rapid Mono test devices
Developer solution
Positive external control and negative external control
25 black-line 10 µL sample-transfer pipettes for serum/plasma
25 red-line 25 µL sample-transfer pipettes for whole blood
Package insert and procedure card
A lancet and timer are required but not provided. A centrifuge capable of separating blood cells from plasma is also required when preparing plasma specimens.
Specimen Requirements
Fingerstick whole blood: Discard the first blood drop, wipe the finger and collect the second free-flowing drop to the red 25 µL fill line.
Venous whole blood: Whole blood collected with CPDA-1, heparin or EDTA may be used. Mix by inversion before testing.
Serum or plasma: Use clear specimens when possible, remove serum or plasma from cells promptly and collect 10 µL to the black pipette fill line.
Specimen condition: Do not use frozen-and-thawed whole blood or grossly hemolyzed whole blood. Clarify serum or plasma containing particulate matter before testing.
Test Procedure Summary
Prepare: Allow test devices, reagents and specimens to reach room temperature. Remove one device from its sealed pouch and place it on a flat surface.
Collect the specimen: Use the red-line 25 µL pipette for whole blood or the black-line 10 µL pipette for serum or plasma.
Transfer: Dispense the collected specimen onto the upper area of the Sample Well (S) according to the pipette instructions.
Add developer: Add 2-3 drops of Developer Solution into the lower area of the Sample Well (S).
Read: Read the result at 8 minutes. Do not interpret the test after 15 minutes.
This summary does not replace the package insert. Follow the current instructions supplied with the kit for specimen collection, quality control, procedure, timing, interpretation, precautions and biohazard disposal.
Understanding the Results
Positive: Pink-purple horizontal bands appear at both the Test (T) and Control (C) positions. Any visible pink-purple test band is interpreted as positive when the control band is present.
Negative: One pink-purple band appears at the Control (C) position and no distinct band appears at the Test (T) position.
Invalid: If no distinct Control (C) band forms, the result is invalid and should not be reported.
Clinical Performance
The package insert reports a comparison involving 576 specimens tested with Accutest Rapid Mono and a commercially available immunochromatographic heterophile-antibody assay. The following values describe agreement with that comparator:
| Performance Measure | Insert-Reported Result |
|---|---|
| Overall agreement | 99.0% (570/576) |
| Relative sensitivity | >99.9% (91/91) |
| Relative specificity | 98.8% (479/485) |
These figures are comparator-agreement results from the study described in the package insert. They are not an overall accuracy guarantee and do not mean the test confirms EBV infection in every patient.
Storage and Specimen Handling
Store the kit at 36-86°F (2-30°C) with test devices sealed in their pouches
Do not freeze the kit and do not use components after their expiration date
Refrigerate specimens at 36-46°F (2-8°C) until testing
Venous whole blood may be held at 36-46°F (2-8°C) for up to 24 hours; do not freeze and thaw whole blood
If serum or plasma will not be tested within 48 hours, store it at or below -4°F (-20°C)
Do not repeatedly freeze and thaw serum or plasma specimens
Instructions and Product Documents
Frequently Asked Questions
What does the Accutest Rapid Mono Test detect?
It qualitatively detects infectious mononucleosis heterophile antibodies in human whole blood, serum or plasma. It is intended as an aid in diagnosing infectious mononucleosis.
Is the Accutest Rapid Mono Test CLIA-waived?
It is CLIA-waived only when performed with fingerstick or venous whole blood according to the package insert. Serum and plasma testing is non-waived/moderate-complexity.
Is this an over-the-counter home mono test?
No OTC or home-use claim is made for this product. It is a professional in-vitro diagnostic test for use according to the manufacturer instructions and applicable laboratory requirements.
Which specimen types can be used?
The test accepts fingerstick whole blood, venous whole blood, serum and plasma. The required volume is 25 µL for whole blood and 10 µL for serum or plasma.
How quickly are results available?
Read the result at 8 minutes and do not interpret the test after 15 minutes. A clearly positive result may appear sooner, but the routine procedure specifies the 8-minute read time.
Are positive and negative controls included?
Yes. The 25-test kit includes positive and negative external controls. The test device also contains internal procedural-control features.
Are there age restrictions?
The manufacturer brochure states that the test has no age restrictions. However, the package insert warns that approximately half of children younger than four years who have infectious mononucleosis may test negative for heterophile antibodies, so EBV-specific testing may be helpful.
Does a positive result confirm an active Epstein-Barr virus infection?
Not by itself. The test detects heterophile antibodies rather than the virus. Results must be interpreted with clinical information, and EBV-specific antibody testing may be appropriate when the presentation or result is atypical.
How should the kit be stored?
Store the kit at 36-86°F (2-30°C) with test devices in their sealed pouches. Do not freeze the kit and do not use components after their printed expiration date.
Looking for Epstein-Barr Virus Testing Information?
Review current CDC information about EBV laboratory testing, heterophile-antibody test limitations and EBV-specific antibody interpretation.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 2 × 6 × 2 in |
