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Legionella Product Sheet

Legionella Product Sheet

Legionella Product Sheet

Product catalog summary
Overview:
The SAS™ Legionella Test is a rapid diagnostic tool designed for the qualitative detection of Legionella pneumophila serogroup 1 antigens in urine, aiding in the diagnosis of Legionnaire’s Disease. It is classified as moderately complex under CLIA regulations.
Specifications:
  • CLIA Classification: Moderately complex
  • CPT Code: 87449
  • Sensitivity: Greater than 90.5%
  • Specificity: Greater than 95%
  • Specimen Type: Urine
  • Storage: Room temperature
  • Shelf Life: 18 months
Test Procedure:
  1. Ensure the test pouch and specimen are at room temperature before opening.
  2. Remove the test device from the pouch and place it on a flat surface. Label the device with patient or control identifications.
  3. Dispense 4 drops (approximately 150µL) of the supernatant into the round sample well.
  4. Wait for colored lines to appear, which should occur within 15 minutes.
Interpreting Results:
  • Negative Result: A colored line appears only in the control (C) area.
  • Positive Result: Colored lines appear in both the control (C) and specimen (S) areas.
  • Results should be read within 15 minutes for accuracy.
Product Information:
  • Product No. 044020: 20-Test Kit for detecting Legionella pneumophila serogroup 1 antigens.
  • Product No. 044413: Control set with 2 x 1 mL vials, for use with Product No. 044020.
Contact Information:
Reliable Diagnostic Tests, 4919 Golden Quail, San Antonio, Texas 78240, U.S.A. Phone: (210) 699-8800, Fax: (210) 699-6545, Website: www.sascientific.com
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Catalog excerpts

Legionella Product Sheet-1

CPT Code: 87449 Sensitivity: >90.5% Specificity: >95% Specimen: Urine SAS™ Legionella Test is a rapid membrane based immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigens in urine. SAS™ Legionella Test aids in the detection of Legionnaire’s Disease. •  CLIA Classification: Moderately complex. • Simple to run—one-step procedure, results within 15 minutes. • Disposable specimen droppers included. • Room temperature storage. Reliable Diagnostic Tests

 Open the catalog to page 1
Legionella Product Sheet-2

Test Procedure The pouch must be at room temperature before opening to avoid condensation of moisture on the membrane. Allow specimen and/or controls to reach room temperature prior to testing. 1. Remove the test device from the protective ­ pouch and place it on a flat surface. Label the device with patient or control identifications. 2. Dispense 4 drops (approximately 150µL) of the supernatant into the round sample well (see i ­llustration). Wait for colored lines to appear. Test Results 15 Minutes Read results in 15 minutes or less. The presence of the control line is not indicative of the...

 Open the catalog to page 2
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