2 6 drops * 10x 3 2 min *NOTE: Adding more then 6 drops during step 2 may provide erroneous results. 1 4 Ultra Strep A Test ® 5 5 min 6 Rev.
® Ultra Strep A Test CLIA Complexity: Waived INTENDED USE The OSOM ® Ultra Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens. For laboratory and professional in vitro diagnostic use only. SUMMARY AND EXPLANATION OF TEST Group A Streptococcus is one of the most important causes of acute upper respiratory tract infection.
• If no glass ampule is inside the Extraction Reagent Bottle or the glass ampule appears to be broken before use (reagent is colorless or yellow), discard and use another Extraction Reagent Bottle. • The Positive and Negative Controls contain sodium azide which may react with lead or copper plumbing to form potentially explosive metal azide. For sites permitted to dispose of material down a sink: large quantities of water must be used to flush discarded control material down a sink.
• The OSOM Ultra Strep A Test should be used only with throat swab specimens. The use of swab specimens taken from other sites or the use of other samples such as saliva, sputum or urine has not been established. • This test does not differentiate between carriers and acute infection. • Pharyngitis may be caused by viral or bacterial pathogens other than Group A Streptococcus (1,2) . • If the test result is inconsistent with the clinical symptoms, a second throat swab should be collected for repeat testing.
Statistical Analysis b for the Sensitivity of the Various Test Methods: Test Method Sensitivity p SSC A vs. SSC B 87 / 94 (92.6%) vs. 82 / 94 (87.2%) 0.3312 OSOM Ultra vs. SSC A 87 / 94 (92.6%) vs. 87 / 94 (92.6%) 0.7811 OIA Max vs. SSC B 71 / 94 (75.5%) vs. 82 / 94 (87.2%) 0.0581 OSOM Ultra vs. OIA Max 87 / 94 (92.6%) vs. 71 / 94 (75.5%) 0.0021 a. N/A, Not applicable, all culture positives are true-positive by definition. b.
TEST PROCEDURE Absorbent End Result Window Handle End STEP 1 Just before testing, squeeze the Extraction Reagent Bottle to crush the ampule inside. Note: The ampule must be crushed before proceeding to the next step. STEP 2 Vigorously shake the Extraction Reagent Bottle 3 – 5 times to mix the contents. The liquid in the Extraction Reagent Bottle should turn from pink to light yellow. 6 drops Add only 6 drops of the Extraction Reagent to the Test Tube.
INTERPRETATION OF TEST RESULTS Positive A blue Test Line and a red Control Line is a positive result. A positive result means that the assay detected Group A Streptococcus antigen in the specimen. Note that the blue line can be any shade of blue and can be lighter or darker than the line in the picture. Negative A red Control Line but no blue Test Line is a negative result.
REFERENCES 1. Youmans, G.P., Paterson, P.Y. and Sommers, H.M., Upper Respiratory Tract Infection: General Considerations, in The Biologic and Clinical Basis of Infectious Diseases, W. B. Saunders Co., Philadelphia, 177 – 183, 1980. 2. Manual of Clinical Microbiology, 7th Edition, Murray, P.R., Baron, E.J., Pfaller, M.A., Tenover, F.C., Yolken, R.H., Eds., Am. Society of Microbiology, Washington, D.C., 1999. 3. CDC, Biosafety in Microbiological and Biomedical Laboratories, 2nd Ed., HHS Publication No.
