Item Brochure
A red Control Line but no blue Test Line is a negative result. A negative result means that no Group A
Streptococcus antigen was detected, or the levels of antigen in the specimen were below the detection
level of the assay.
Invalid
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.
8808395, 4-6,1988.
4. American Academy of Pediatrics. Summaries of Infectious Disease. In: Pickering LK, ed. 2000
Red Book: Report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American
Academy of Pediatrics 2000: 528.
5. Lauer, B.A., Reller, L.B., and Mirrett, S., Effect of Atmosphere and Duration of Incubation on Primary
Isolation of Group A Streptococci from Throat Cultures, J. Clin. Microb., 17: 338 – 340, 1983.
6. Wannamaker, L.W., Differences Between Streptococcal Infections of the Throat and of the Skin, N.
Eng. J. Med., 282: 23 – 31, 78 – 85, 1970.
7. Fleiss, J. L., Statistical Methods for Rates and Proportions, 2nd Ed., John Wiley & Sons, 1981.
ASSISTANCE
For assistance, call Sekisui Diagnostics Technical Service at 800-332-1042.
RE-ORDER
No. 147 (25 Tests)
KEY TO COMPONENT LABELING
OSOM
®
is a registered U.S. trademark of Sekisui Diagnostics, LLC.
** Patent number 6,194,221
*** OIA
®
is a registered trademark of Inverness Medical – BioStar Inc. and the Strep A OIA
Max Test is manufactured by Inverness Medical – BioStar Inc.
Licensed under U.S. Patent Nos. 5,714,389; 5,989,921, 6,485,982 and 6,979,576 and
related non-U.S. patents and patent applications.
Sekisui Diagnostics, LLC 6659 Top Gun Street, San Diego, CA 92121 USA
Use by YYYY-MM
Batch code
Catalog number
Contents sufficient for <n> tests
In vitro diagnostic medical device
Temperature limitation
Manufacturer/Manufactured by
Consult instructions for use
Authorized representative
in the European Community
Oxidizer, consult the SDS for
further information .
Warning, consult the SDS for
further information
Tel: 80 0-332-1042
www.sekisuidiagnostics.com
© 2015 Sekisui Diagnostics, LLC – All rights reserved.