FDA - Influenza Rapid Test Reclassification (Class II) Effective January 12, 2018

Dear All,

We are very sorry to inform you that due to recent FDA regulatory changes, we will not be carrying the Rapid Response™ Flu Kit for the time being. We understand this may cause inconveniences, however, this is strictly due to the FDA’s recent reclassification. As per the FDA ruling, tests that fell under the original Class I (current Rapid- Response™ Flu Kits) cannot be marketed, sold or distributed after January 12. However, any affected products purchased prior to January 12, 2018 may still be used until their expiration date. We have already submitted for our Class II approval with the FDA and we will gladly contact our clientele via the Lochness Medical website with any future updates.

In accordance with the new reclassification, the FDA has provided the following details and reasoning for the changes:

  • The FDA will be requiring special controls to establish an improved industry standard for testing (a call-to-action to address the industry concerns exposed in the 2009 Flu pandemic).
  • New Class II tests will require premarket notification and controls that will be used to Identify and test for newly emerging strains of the Influenza virus as well as contemporary strains.
  • The goal is to improve the overall number of misdiagnosed treatments.
  • In collaboration with the Centers for Disease Control and Prevention, the FDA will provide an Influenza Virus Analytical Reactivity Test Panel to all manufacturers of antigen-based RIDTs in order to evaluate the reactivity of their assays with current and circulating viruses.

We hope this clarifies any questions you might have regarding the indefinite suspension to the industries availability to Rapid Flu Tests. Again, updates will be available at www.lochnessmedical.com.

Sincerely,

Lochness Medical Inc.


The Rapid ResponseTM Influenza A and Influenza B Test Cassettes are rapid, qualitative tests for the detection of influenza type A and B nucleoprotein antigens from nasal washes and aspirate samples, to aid in the diagnosis of influenza A and influenza B infections. They are intended for professional in vitro diagnostic use only. Interpretation of test results are: Flu A OR Flu B positive (two lines), negative (one line), invalid (no lines or no Control line).

Product Information
  • Product Code: FLUAB-19C15
  • Sample: Nasopharyngeal Washes and Aspirates
  • Format: Cassette
  • Specificity: Influenza A & Influenza B Antigens
  • Accuracy: Flu A: 91.6%, Flu B: 99.2%
  • Time-to-Result: 15 minutes
  • Storage Condition: 59-86°F/15-30°C
  • Test Principle: Lateral Flow Immunoassay
Contents
  • 15 Flu A Test Cassettes
  • 15 Flu B Test Cassettes
  • 30 Extraction Tubes with Filter Caps
  • 60 Disposable 250μl Pipettes
  • 2 Bottles of Extraction Buffer (15 mL each)
  • Product Inserts

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Frequently Asked Questions (FAQ)

Answer: Yes, Lochness Medical Inc. Rapid Response Fecal Immunochemical Test (FIT) Kit is (FDA) Cleared and waived by the Clinical Laboratory Improvement Amendments (CLIA).

Answer: Yes, The 2008 American College Of Gastroenterology Guidelines for Colorectal Cancer Screening states: “The preferred cancer detection test is annual FIT. This test has superior performance characteristics when compared with older guaiac-based Hemoccult II cards (15 – 17) 1

Answer: Yes, the Rapid Response Fecal Immunochemical Test (FIT) Kit has an accuracy of 98%. The Guaiac based test(s) / Hemoccult Cards has an accuracy of 86%. The Guaiac based test(s) /Hemoccult Cards requires 3 stool samples on 3 different days (300,000 ng/mL sensitivity). The Rapid Response Fecal Immunochemical Test (FIT) Kit requires only 1 stool sample (50 ng/mL sensitivity). Patients must avoid Aspirin, Red meat, Vitamin C, Fruit Juices before they take a test that’s Guaiac based/Hemoccult Cards. There aren’t any dietary restrictions for the Rapid Response Fecal Immunochemical Test (FIT) Kit. Patients who conduct the FIT Test at their residence returns only the FIT Buffer Tube. The Guaiac based test(s) / Hemoccult Cards causes patients to return a stool sample, which can be messy.

Answer: The Sample Collection for the ICT may be described as messy, protracted and associated with low compliance. The Sample Collection for the FIT Test may be described as simple, one-step, hygenic and high compliance. The FIT Test is more sensitive than ICT (50 ng/mL versus 75 ng/mL).The Positive and Negative agreement between the two test approaches 100%.

Answer: No, Lochness Medical Inc. Fecal Immunochemical Test (FIT) Kit does not have any dietary restrictions.

Answer: No, Lochness Medical Inc. Fecal Immunochemical Test (FIT) Kit does not have any medical restrictions.

Answer: Store test device at room temperature (15-28°C or 59-82.4°F). Refer to the expiration date printed on the foil pouch for stability. Sample collection tube after collecting sample should be stored refrigerated (2-8°C or 35.6-46.4°F) if not used immediately.

Answer: The kit contains 36 test devices, 36 sample collection tubes, and 1 package insert.

Answer: The Rapid Response Fecal Immunochemical Test (FIT) Test Kit is 98% accurate.

Answer: No, the Rapid Response Fecal Immunochemical Test (FIT) Test is specific to human hemoglobin.

Answer: The analytical sensitivity of the Rapid Response Fecal Immunochemical Test (FIT) Test is 50 ng hHb/ml buffer or 5 ug hHb/g feces.

Answer: The false positives for the Rapid Response Fecal Immunochemical Test (FIT) Test Kit are roughly 6%. However, it is looking for human hemoglobin (blood), not paroxadais activity. When a FIT Test has a positive test result, there’s the assurance that blood is in the stool. This could be indicative of diverticulitits, colitis, Chron’s disease, hemorrids, etc.

Answer: No, the Rapid Response Fecal Immunochemical Test (FIT) Test is specific to human hemoglobin.

Answer: Yes, you can take the FIT test regardless of menstruation.

Answer: The shelf life is 24 months from the date of manufacture.

Answer: The national average insurance reimbursement for the Rapid Response Fecal Immunochemical Test (FIT) Test Kit is $21.86.

Answer: No, the CPT Codes are 82274QW for insurance and G0328QW for Medicare.

Answer: Yes, Lochness Medical Inc. offers FIT Mailers separately. The kit contains 50 FIT Mailers. The product code is FOB-9V30.

Answer: Unscrew the cap with the spiral applicator from the sample collection tube. Use the spiral applicator to poke into the stool at 6 different sites. Collect the amount necessary to only cover the grooves of the spiral applicator. More information about collecting sample specimen can be found in the FIT Mailers’ Manual/Quick Card.2

Answer: Yes, the collection paper’s material allows the convenience to flush it down the toilet.

Answer: No, the Rapid Response Fecal Immunochemical Test (FIT) Test is specific to human hemoglobin.

Answer: Specimen can be left in the collection tube for 7 days at room temperature and 14 days refrigerated.

1. Rex,MD,FACG, Douglas K., David A. Johnson, MD, FACG, Johnson C. Anderson, MD, Phillip S. Schoenfeld,MD,MSEd, MSc,(Eqi), Carol A. Burke,MD,FACG, and John M. Inadomi, MD,FACG. "American College of Gastroenterology Guidelines for." 104. (2009): n. page. Web. 11 Feb. 2014.

3. Rapid Response® (FIT) Mailers Manual/Quick card, rev. 2013