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ManualsBrandsSekisui Diagnostics ManualsRapid TestsOsom® Strep A Test - 50/kit

Rev. 3096-3, 05/16

Strep A Test

4 5321

1 min 5 min

10x

3 drops 3 drops

POSITIVE

NEGATIVE

INVALID

Summary of content (6 pages)

PAGE 1
3 drops 1 3 drops 10x 2 1 min 3 Strep A Test ® 4 5 min 5 Rev.
PAGE 2
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. Faklam, R.R. and Washington, J.A., Streptococcus and Related Catalase-Negative Gram-Positive Cocci, in Manual of Clinical Microbiology, 5th Edition, Balows, A., Hausler, W.J., Herrmann, K.L., Isenberg, H.D., and Shadomy, H.J., Eds., Am. Society of Microbiology, Washington, D.C.
PAGE 3
® Strep A Test CLIA Complexity, testing from throat swabs: Waived CLIA Complexity, testing from colonies recovered from culture: Moderate INTENDED USE The OSOM ® Strep A Test is intended for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies recovered from culture. For laboratory and professional in vitro diagnostic use only.
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• For in vitro diagnostic use. • Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner. • Follow your laboratory safety guidelines in the collection, handling, storage and disposal of controls, patient specimens and all items exposed to patient specimens (3) . • T he Positive and Negative Controls contain sodium azide which may react with lead or copper plumbing to form potentially explosive metal azide.
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• T his test does not differentiate between carriers and acute infection. Pharyngitis may be caused by organisms other than Group A Streptococcus (1,2) . • A negative result may be obtained if the specimen is inadequate or antigen concentration is below the sensitivity of the test. • T he American Academy of Pediatrics states (4) : “Several rapid diagnostic tests for GAS pharyngitis are available ...
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• Let stand for 1 minute. •E xpress as much liquid as possible from the swab by squeezing the sides of the tube as the swab is withdrawn.Discard the swab. •R emove Test Stick(s) from the container; re-cap container immediately. •P lace the Absorbent End of the Test Stick into the extracted sample. 1 min 5 min • Read results at 5 minutes. Positive results may be read as soon as the red Control Line appears. • Results are invalid after the stated read time. The use of a timer is recommended.