Mono test handling and interpretation

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Questions and Answers

What indicates a valid positive result for the detection of infectious mononucleosis heterophile antibody?

A blue Test Line and a faint blue Control Line

A red Test Line with no blue Control Line

A blue Test Line and a red Control Line (correct)

Both lines are of equal color and density

What should be done if no red Control Line appears after 5 minutes?

Contact the patient for further instructions

Record the result as positive immediately

Consider the result valid and report it as negative

Repeat the test on a new Test Stick (correct)

Which statement regarding sample collection is accurate?

Blood samples must be collected under direct sunlight

Only whole blood is suitable for testing

Samples should be collected in a non-sterile environment

Plasma or serum specimens may cause benign artifacts on the test stick (correct)

When is the test result considered invalid?

When no red Control Line appears and the background is clear Signup and view all the answers

What characteristic of the blue Test Line indicates a valid positive result?

It can be any shade of blue, lighter or darker Signup and view all the answers

What should be done with specimens that are held for longer than 48 hours?

They should be frozen below -10°C and tested within 3 months. Signup and view all the answers

What is the correct procedure for collecting a fingertip whole blood sample?

Touch the capillary tube to the drop of blood while holding it horizontally. Signup and view all the answers

Which of the following statements about quality control is true?

One free falling drop of control is added to the test tube for external QC testing. Signup and view all the answers

What precautions should be taken regarding the Diluent and Controls?

Avoid contact with skin to prevent allergic reactions. Signup and view all the answers

At what temperature should whole blood specimens be tested?

At room temperature (15°-30°C) Signup and view all the answers

What material should whole blood specimens be collected in to prevent coagulation?

Vacuum tubes containing EDTA or heparin Signup and view all the answers

What must be done if large quantities of control material are to be disposed of down a sink?

Flush with large quantities of water. Signup and view all the answers

How should specimens be stored to maintain their integrity before testing?

Serum and plasma can be refrigerated, while whole blood must be tested within 24 hours. Signup and view all the answers

What does a clear background indicate in the OSOM Mono Test?

The internal negative control is working properly Signup and view all the answers

What action should be taken if the red Control Line does not appear in the OSOM Mono Test?

Repeat the test on a new Test Stick Signup and view all the answers

When should positive and negative external controls be run according to Sekisui Diagnostics?

With each new lot and with each new untrained operator Signup and view all the answers

What procedure should be followed for fingertip blood sample collection?

Fill a capillary tube and dispense all blood into the Test Tube Signup and view all the answers

What must be done immediately after removing the Test Stick from its container?

Re-cap the container right away Signup and view all the answers

What limitation exists regarding the OSOM Mono Test results?

Negative results may occur early in the disease due to low antibody levels Signup and view all the answers

What constitutes an invalid result in the OSOM Mono Test?

The background does not clear and interferes with results Signup and view all the answers

What is the significance of the red Control Line in the OSOM Mono Test?

Serves as an internal positive control for the test Signup and view all the answers

Study Notes

Storage & Handling

Test sticks and reagents should be stored at 15°-30°C (59°-86°F) and kept tightly capped.
Do not use the test sticks or reagents after their expiration dates.

Materials Required

Specimen collection containers
Timer or watch

Warnings & Precautions

May cause allergic skin reaction (H317).
Wear protective gloves/protective clothing/eye protection/face protection (P280).
For in-vitro diagnostic use only.
Follow laboratory safety guidelines for specimen collection, handling, storage, and disposal.
Diluent and Controls contain sodium azide, which can react with lead or copper plumbing to form potentially explosive metal azide.
Flush large quantities of water down the sink when disposing of control material.
The Capillary Bulb contains dry natural rubber.
Do not interchange or mix components from different kit lots.

Specimen Collection & Preparation

Collect serum, plasma, or whole blood specimens using acceptable medical techniques.
For whole blood samples, use a tube containing EDTA or heparin as an anticoagulant.
Refrigerate serum and plasma specimens (2°-8°C; 36°-46°F) and test within 48 hours.
For longer storage, freeze serum and plasma specimens (below -10°C; 14°F) and test within 3 months.
Test whole blood specimens within 24 hours.
Specimens must be at room temperature (15°-30°C; 59°-86°F) when tested.
For fingertip whole blood:
- Hold the capillary tube horizontally while collecting the sample.
- Touch the other end of the capillary tube to the drop of blood on the patient’s finger.
- Fill the capillary tube completely.
- Place the small end of the black bulb onto the capillary tube.
- Place your fingertip over the opening in the bulb.
- Squeeze the bulb to dispense the whole blood sample into the test tube.

Quality Control

External Quality Control:
- Use the controls provided in the kit for external QC testing.
- Add one free-falling drop of control to the Test Tube.
- Proceed in the same manner as with a patient sample.
- Establish quality control requirements in accordance with local, state, and federal regulations or accreditation requirements.
- Sekisui Diagnostics recommends running positive and negative external controls with each new lot and each new untrained operator.
- Do not use commercial controls that contain interfering additives.
Internal Quality Controls:
- The OSOM Mono Test provides two levels of internal procedural controls with each test procedure.
- The red Control Line is an internal positive control:
  - The Test Stick must absorb the proper amount of sample and be working properly for the red Control Line to appear.
- A clear background is an internal negative control.
  - If the test has been performed correctly and the Test Stick is working properly, the background will clear.
- If the red Control Line does not appear, the test is invalid.
- If the background does not clear, the test may be invalid.
- Contact Sekisui Diagnostics Technical Assistance if you experience either of these problems.

Limitations

The results obtained by OSOM Mono Test should be used as an adjunct to other available medical information.
The OSOM Mono Test is a qualitative test for the detection of IM heterophile antibody.
A negative result may be obtained from patients at the onset of the disease due to heterophile antibody levels below the sensitivity of the test kit.
If symptoms persist or intensify, repeat the test.
Some individuals with acute infectious mononucleosis are heterophile antibody negative.

Test Procedure

Addition of Specimen:
- For serum, plasma, or whole blood samples in tubes:
  - Use the Transfer Pipette provided.
  - Add one drop to the Test Tube.
- For fingertip blood:
  - After filling a capillary tube end to end, dispense all of the blood into the Test Tube.
  - Slowly add 1 drop of Diluent to the bottom of the Test Tube.
  - Mix.
Test Stick Application:
- Remove the Test Stick from the container.
- Immediately re-cap the container.
- Place the Absorbent End of the Test Stick into the treated sample.
- Leave the Test Stick in the Test Tube.
Reading Results:
- Read results at 5 minutes.
- Positive results may be read as soon as the red Control Line appears.

Interpretation of Test Results

Positive Result:
- A blue or red line that appears uneven in color density is considered a valid result.
- A blue Test Line and a red Control Line indicate a positive result for the detection of infectious mononucleosis heterophile antibody.
- The shade of blue can vary.
Negative Result:
- A red Control Line but no blue Test Line indicates a negative result.
- No infectious mononucleosis heterophile antibody has been detected.
Invalid Result:
- If after 5 minutes, no red Control Line appears, or the background color makes reading the red Control Line impossible, the result is invalid.
- Repeat the test on a new Test Stick or call Sekisui Diagnostics Technical Assistance.

Artifact

A dry white line located near the Test and/or Control line positions may be observed on some test sticks.
It has no impact on the performance of the assay.

Normal Values

Negative

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Description

This quiz focuses on the essential protocols for storage, handling, and disposal of laboratory specimens and reagents. It covers safety precautions, materials required, and proper techniques for specimen collection. Understanding these guidelines is crucial for maintaining safety and accuracy in laboratory environments.