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ICONDS STREP A
ICONDS Strep A is a qualitative assay for rapid detection of Strep A antigen from throat swabs. The ICONDS Strep A test excels at detection of Strep A antigen, especially in rare and low positive colonization samples. This CLIA Waived test uses a convenient dipstick format, and boasts 97% sensitivity and 95% specificity. This easy test gives results within 5 minutes and can be stored at room temperature. With outstanding performance, ICONDS Strep A leaves little chance for misdiagnosis, minimizing the risk of rheumatic fever or overprescription of antibiotics.
PRODUCT FEATURES
  • CLIA Waived
  • 97% sensitivity, 95% specificity
  • Results in minutes
  • Easy to use dipstick format
  • Room temperature storage, long shelf life

Frequently Asked Questions (FAQs)

1. Specimen

Q: What kind of swab should be used to collect a throat swab specimen?
A: Use only the sterile, Dacron-tipped swabs provided in the kit. Other swabs have not been validated for use with the test and may affect the expected test results. The swabs in the kit are from Hardwood Products Company (1-800-321-2313) and are available as part number 25-806-IPD.

Q: How should specimens be collected?
A: Swab the posterior pharynx, tonsils, and other inflamed areas of the throat. Avoid touching the tongue, cheeks, and teeth with the swab, as substances from these areas may affect test performance. Also, excess blood or mucus on the specimen may interfere with test performance and may yield a false positive result. Therefore, avoid touching any bleeding areas of the mouth with the swab when collecting specimens.

Q: Can specimens be stored prior to testing?
A: Ideally, testing should be performed immediately after the specimen has been collected. If this is not possible, specimens may be kept at room temperature for up to four hours in a sterile tube/container that is capped or otherwise covered securely. Specimens should NOT be refrigerated prior to use as this has been found in some instances to affect test performance.

Q: Will transport media affect the test?
A: Swab Transport media has not been validated with the test.

2. Test Detection

Q: What part of the Strep A antigen is detected?
A: The carbohydrate portion of the antigen is detected.

Q: What is the antigen detection level of the test?
A: The test is able to detect at least 2.5 x 105 organisms per swab.

Q: A patient completed antibiotic treatment for Strep throat and was then re-tested with the ICONDS Strep A Rapid Test Strip and culture. The rapid test result was still positive, while the culture result was negative. Why?
A: The ICONDS Strep A rapid test strip is an antigen detection test. It is able to detect antigen from both viable (live) and non-viable (dead) Strep A organisms. This explains why the rapid test result may still be positive even though the viable disease was eradicated after treatment (which in turn is why the culture result was negative).

Q: Is there any “hook” effect? If so, at what level of Strep A organisms/antigen? If not, what is the highest level of Strep A tested?
A: No, there is no hook effect. The highest level of Strep A tested is 1 x 1010 organism per swab. This level still produced the correct (positive) result.

Q: Can this test be used for culture confirmation?
A: No, this test is not designed for culture confirmation and is for the qualitative detection of Strep A in throat swab specimens only.

3. Test Procedure

Q: Can the same swab be streaked for culture and then tested with the ICONDS Strep A test?
A: Yes, a swab can be streaked for culture FIRST, then tested with ICONDS Strep A.

Q: Why is it important to hold the bottles vertically when dispensing Reagent A & Reagent B into the extraction test tube, as indicated in the Product Instructions?
A: Holding the bottles vertically rather than tilted at an angle ensures that the dispensed drops are of the correct volume. It helps to obtain full drop size and avoid air bubbles during the squeezing of the bottles.

Q: If the solution mixture does not change to pale yellow when Reagent B (colorless) is added to Reagent A (red), can the solution be used for the test anyway?
A: No. If the color change does not occur, the reagents may be contaminated because the bottle caps were interchanged or the incorrect number of drops was used. Try repeating the procedure with a new extraction test tube and the correct number of drops (4 drops of Reagent A & 4 drops of Reagent B). The solution mixture must turn pale yellow for it to be used for a test.

Q: Are Reagent A & Reagent B lot-specific? In other words, can the bottles of Reagent A & B from one kit be used with test strips from another kit of a different lot number?
A: Reagent A & Reagent B are not lot-specific. However, we recommend that test components not be mixed from lot to lot.

Q: How important is it to rotate the throat swab at least 10 times after it is placed into the test tube containing extract solution, as indicated in the Product Instructions?
A: This is an important part of the extraction process. Rotating the swab at least 10 times inside the test tube is critical in extracting any Strep A antigen that may be present on the swab into the liquid solution that will be used for the test strip.

Q: If the ICONDS Strep A test strip is placed into the tube of solution after the extraction and the solution exceeds the maximum line ((MAX) on Product Instructions illustration) indicated on the test strip, what does this mean?
A: If the solution exceeds the maximum line on the strip, the extraction procedure was probably not followed correctly (too much of Reagent A and/or B was used). The excess volume may “flood” the test strip (wet the result area) and affect test performance.

Q: If the ICONDS Strep A test strip is placed into the test tube of solution after the extraction, and the solution remaining in the tube is of very low volume (seemingly too little to be normally absorbed by the test strip), what does this mean?
A: If too little solution remains in the tube after the extraction procedure, it may not have been adequately “squeezed” out of the swab as the swab was removed from the tube and discarded.

Q: If the ICONDS Strep A test is used before the components reach room temperature, is the result reliable?
A: No. The ICONDS Strep A test components must be at room temperature (15-30C) before the test is performed.

Q: If the ICONDS Strep A test strip was removed from the foil pouch and dropped on the floor prior to using it, will it still work?
A: If the ICONDS Strep A test is intact and the exposed membrane in the “reaction window” was not damaged, it can still be used and expected to function properly.

Q: Liquid was inadvertently applied onto the “reaction window” of the ICONDS Strep A test. Will it still work?
A: No. Addition of any type of liquid into any other location other than the ICON DS Strep A test’s designated sample application port renders the test invalid. Use a new test.

4. External Controls

Q: What is the concentration of the positive control solution?
A: 1 x 109 organisms/mL

Q: What is the concentration of the negative control solution?
A: 1 x 108 organisms/mL

Q: The procedure for running the controls requires one drop of control solution to be added to the tube of extraction solution. What volume is this?
A: One drop of control solution is equivalent to 40 mL.

Q: The Product Instructions indicates that the control solutions contain “non-viable” Strep A & Strep C. What does this mean?
A: The Strep A & C organisms are heat-inactivated (killed). Nevertheless, the usual precautions should be taken against microbiological hazards when performing the test and using the control solutions.

Q: Are the ICONDS Strep A positive and negative controls lot-specific? In other words, can the control bottles from one kit be used with test strips from another kit of a different lot number?
A: The ICONDS Strep A positive and negative controls are not lot-specific. However, we recommend that test components not be mixed from lot to lot.

5. Interpretation

Q: When the sample is added to the ICONDS Strep A test, red/pink fluid can be seen migrating up the membrane. Is this normal?
A: A red/pink background is normal as the sample flows up the ICONDS Strep A test strip and will not affect the test result. As long as it does not interfere with the interpretation of the line(s), the background can be disregarded.

Q: How does one know that the ICONDS Strep A test has been performed properly?
A: As an internal procedural control, a red line appearing in the control (C) region confirms the application of sufficient sample volume and the performance of correct procedural technique.

Q: A positive result is read when two distinct red lines appear on the ICONDS Strep A test strip, One line the control region (C) and another line the test region (T). Do the two lines need to be of the same intensity?
A: No. The intensity of the red color in the test line region (T) will vary. Any shade of a red line in the test (T) region (darker than, the same color as, or lighter than the control line) along with a red line in the control (C) region is considered a positive result.

Q: Will a positive result stay positive on the ICONDS Strep A test?
A: A positive result (two distinct red lines) usually does not change on the ICON DS Strep A test. However, fading of the lines may occur several hours after the test is performed.

Q: Can the result be read before the specified read time?
A: No. Even though a positive result may appear earlier, it is important that the ICONDS Strep A test be allowed to fully develop for 5 minutes.

5. Storage

Q: How should the ICONDS Strep A test kits be stored?
A: Store the ICONDS Strep A tests as packaged in their sealed pouch at 2 to 30C until use. Do not freeze the tests or any of the components. If stored refrigerated (2 to 8C), allow the tests and/or components to equilibrate to room temperature (15 to 30C) prior to use.

Q: Can the ICONDS Strep A test be used beyond the expiration date?
A: No. The ICONDS Strep A test strips and components should not be used under any circumstances past their expiration date.

For technical assistance, contact Technical Marketing at 800-877-6242 or 650-845-3526 or e-mail askpcd@beckman.com.

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