Quality Control - Gima STREP A Manual De Uso

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ENGLISH
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test
line region (T). A negative
result indicates that Strep A antigen is not present in the specimen, or is present below the
detectable level of the test. The patient's
specimen should be cultured to confirm the absence of Strep A infection. If clinical symptoms
are not consistent with results, obtain
another specimen for culture.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural
techniques are the most likely
reasons for control line failure. Review the procedure and repeat the test with a new test. If the
problem persists, discontinue using
the test immediately and contact your local distributor.

QUALITY CONTROL

Internal Quality Control
Internal procedural controls are included in the test. A colored line appearing in the control line
region (C) is an internal positive procedural control. It confirms sufficient specimen volume,
adequate membrane wicking and correct procedural technique.
External Quality Control
It is recommended that a positive and negative external control be run every 25 tests, and as
deemed necessary by internal laboratory procedures. External positive and negative controls
are supplied in the kit. Alternatively, other Group A and non-Group A Streptococcus reference
strains may be used as external controls. Some commercial controls may contain interfering
preservatives; therefore, other commercial controls are not recommended.
Procedure for External Quality Control Testing
1. Add 5 full drops of Reagent A and 5 full drops of Reagent B into the swab chamber of a test,
holding the bottles upright.
2. Add 1 full drop of positive or negative control solution into the swab chamber, holding the bottle
upright.
3. Place a clean swab into the swab chamber. While holding the base of the chamber, agitate
the swab vigorously 10 times in the swab chamber. Leave the swab in the chamber for 1 minute.
4. Continue with Step 4 of Directions For Use.
If the controls do not yield the expected results, do not use the test results. Repeat the test or
contact your distributor.
LIMITATIONS
1. The Strep A Twist Rapid Test Device (Throat Swab) is for in vitro diagnostic use only. The test
should be used for the detection of Strep A antigen in throat swab specimens only. Neither the
quantitative value nor the rate of increase in Strep A antigen concentration can be determined by
this qualitative test.
2. This test will only indicate the presence of Strep A antigen in the specimen from both viable
and non-viable Group A Streptococcus bacteria.
3. A negative result should be confirmed by culture. A negative result may be obtained if the
concentration of the Strep A antigen present in the throat swab is not adequate or is below the
detectable level of the test.
4. Excess blood or mucus on the swab specimen may interfere with test performance and may
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yield a false positive result. Avoid touching the tongue, cheeks, teeth or any bleeding areas of
the mouth with the swab when collecting specimens.