Item Brochure

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specimens may be held at room temperature for no longer than 24 hours. Swabs may also
be stored at 4°C or -20°C for up to 36 hours.
• To run a culture as well as the OSOM Test, separate swabs must be collected because the
Sample Buffer will kill Trichomonas organisms.
QUALITY CONTROL (QC)
The OSOM
Trichomonas Rapid Test provides two methods of control for the assay:
internal controls to aid in determining test validity, and external controls to demonstrate
proper test function.
Internal Procedural Controls
Several controls are incorporated into each Test Stick for routine quality checks.
1. The appearance of the control line in the results window is an internal positive
procedural control.
Test System: The appearance of the control line assures that adequate sample volume was
present. It also ensures that adequate capillary migration of the sample has occurred. It also
veries proper assembly of the Test Stick.
Operator: The appearance of the control line indicates that enough sample volume was present
for capillary ow to occur. If the control line does not appear at the read time, the test is invalid.
2. The clearing of the background in the results area may be documented as an internal
negative procedural control. It also serves as an additional capillary ow control. At the read
time, the background should appear white to light grey and not interfere with the reading
of the test. The test is invalid if the background fails to clear and hides the appearance of
a distinct control band. If any background color does not clear and interferes with the test
result, the test may be invalid.
External Quality Control Testing
OSOM Test kits include a Positive Control Swab for external quality control testing. Kit swabs
may be used as negative controls. Additional Positive Control Swabs may be purchased
separately (Trichomonas Positive Control Kit catalog number 182). Use the Controls to
ensure that the Test Sticks are functioning properly. Also, the Controls may be used to
demonstrate proper performance by the test operator. 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 Procedures
The Positive Control Swab is impregnated with sufcient Trichomonas antigen to produce a
visible positive test result. To perform a positive or negative control test, complete the steps in
the Test Procedure section treating the control swab in the same manner as a specimen swab.
EXPECTED RESULTS
Studies have shown that the incidence of Trichomonas infections by culture in women
presenting to STD clinics is between 8-37%
1,2
. In a clinical trial involving the OSOM
Trichomonas Rapid Test at seven sites, including STD clinics, hospital emergency
departments, and public health clinics, the prevalence of Trichomonas Infections detected
by culture or wet mount ranged from 13% to 29%. Up to 50% of women infected with
Trichomonas may not be aware of symptomology. The highest incidence of this disease is
found in women with at-risk factors that predispose them to acquiring sexually transmitted
diseases. Trichomoniasis also has a high likelihood of co-infection with other STDs,
including those that also result in symptoms of vaginitis.
LIMITATIONS OF THE PROCEDURE
• The OSOM Trichomonas Rapid Test is only for the qualitative detection of T. vaginalis antigen
from vaginal swabs and the saline solution remaining from a wet mount of a vaginal swab.
• The performance of the OSOM Trichomonas Rapid Test with specimens other than vaginal
uid or the saline solution remaining from a wet mount of a vaginal swab has not been
established.
• The results obtained with this kit yield data that must be used only as an adjunct to other
information available to the physician.