Item Brochure

• 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)
.
• 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.
• Do not interchange or mix components from different kit lots.
SPECIMEN COLLECTION AND PREPARATION
• Collect specimens with a sterile swab from the tonsils and/or the back of the throat
(2)
taking care to
avoid the teeth, gums, tongue or cheek surfaces.
• Do not use swabs with cotton tips, wooden shafts or calcium alginate swabs.
• Do not use a collection system that contains charcoal or semisolid transport media.
• If your lab requires a culture result as well as the OSOM Strep A Test result, streak the culture plate with
the swab before starting the OSOM Strep A Test procedure as the extraction reagents will cause the
specimen to become nonviable.
• Process the swab as soon as possible after collecting the specimen. If you do not perform the OSOM
Strep A test immediately, store the swabs either at room temperature or refrigerated for up to 72 hours.
The swabs and the test kit must be at room temperature prior to running the test.
• Sample Transport:
• Because the performance characteristics of this product were established with the sterile
rayon swabs supplied with the kit, we recommend using these swabs to assure optimal
performance.You may purchase the kit swabs in a double swab/dry tube format as an
accessory (Sekisui Diagnostics Part #7784).
• Because the test does not require live organisms for processing, a rayon transport swab
containing Stuart’s or Amies media may also be used; however, swabs from other suppliers
have not been validated.
CULTURE CONFIRMATION
The OSOM Strep A Test can also be used to confirm the identification of Group A Streptococcus on blood
agar plates. The plates must be less than 72 hours old. Lightly touch 1 – 3 suspect colonies (showing
characteristic beta hemolysis) using a sterile swab. Do not sweep the plate. Follow the instructions in the
TEST PROCEDURE section to test the swab.
QUALITY CONTROL
Internal Procedural Controls
The OSOM Strep A Test provides three levels of procedural controls with each test run:
• The color of the liquid changes from pink to light yellow as you add Extraction Reagent 2 to Extraction
Reagent 1. This is an internal extraction reagent control. The color change means that you mixed the
extraction reagents properly. The color change also means that the reagents are functioning properly.
• The red Control Line is an internal positive procedural control. The Test Stick must absorb the proper
amount of sample and the Test Stick must be working properly for the red Control Line to appear.
For the Test Stick to be working properly, the capillary flow must occur.
• A clear background is an internal background negative procedural control. If no interfering substances
are in the specimen and the Test Stick is working properly, the background in the Control Line area will
clear. A discernible result will be seen.
If the red Control Line does not appear, the test may be invalid. If the background does not clear and
interferes with the test result, the test may be invalid. Call Sekisui Diagnostics Technical Service if you
experience either of these problems.
External Quality Control Testing
Each kit contains Positive and Negative Control material. The Controls are for external quality control
testing. Use the Controls to test that the extraction reagents and the Test Sticks are working. Also use
the Controls to test that you are able to correctly perform the test procedure. If you choose, you may use
Group A and non Group A Streptococcus ATCC reference strains as controls. Some commercial controls
may contain interfering additives. Therefore Sekisui Diagnostics recommends that you do not use other
commercial controls with the OSOM Strep A Test.
Quality Control requirements should be established in accordance with local, state and federal
regulations or accreditation requirements. Minimally, Sekisui Diagnostics recommends that positive
and negative external controls be run with each new lot and with each new untrained operator.
QC Testing Procedure:
• Dispense 3 drops Reagent 1 and 3 drops Reagent 2 into Test Tube.
• Vigorously mix the control contents. Add 1 free falling drop of Control from dropper bottle.
• Place a clean swab into the Tube.
• Continue as you would for a patient sample, as instructed in the PROCEDURE section.
LIMITATIONS
• The OSOM Strep A Test has been categorized as CLIA waived only for the application of qualitative
detection of Group A Streptococcal Antigen from throat swabs. The application for the confirmation of
presumptive Group A Streptococcal colonies recovered from culture is not waived.
• The results obtained with this kit yield data that must be used only as an adjunct to other information
available to the physician. The OSOM Strep A Test is a qualitative test for the detection of Group A
Streptococcal antigen. This test does not differentiate between viable and nonviable Group A Streptococci.
• The OSOM Strep A Test should be used only with throat swabs or colonies taken directly from a plate. 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. The quality of the test depends on the quality of the sample;proper throat
swab specimens must be obtained.