Directions For Use; Interpretation Of Results - Gima STREP A Manual De Uso

11

DIRECTIONS FOR USE

Allow the test, reagents, and/or controls to reach room temperature (15-30°C) prior to
testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the
sealed pouch and use it as soon as possible. The 2 marks on top of the ribbed part of the valve
should be positioned as shown in the image below (Closed Valve Position). If they are not, turn
the ribbed part of the valve counterclockwise until it stops.
Mark Result Window
Closed Valve Position
2. Hold the bottle upright and add 5 full drops of Reagent A (approximately 300 µL) to the swab
chamber. Reagent A is red in color. Hold the bottle upright and add 5 full drops of Reagent B
(approximately 200 µL) to the swab chamber. Reagent B is colorless.
3. Immediately add the throat 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. Remove the swab by holding down the swab chamber with the thumb
and index finger. Lift the swab halfway up the chamber and press it against
the ribs inside the wall of the chamber. Rotate the swab 5 times while
pressing firmly against the ribs to release as much liquid as possible (see
image at right). Discard the swab.
5. Open the valve by twisting the ribbed part of the valve clockwise until it stops and then start
the timer. The 2 marks on top of the ribbed part of the valve should be aligned with the result
window, as shown in the image above (Open Valve Position). If the liquid has not appeared in the
window 1 minute after the valve is opened, discard the device and repeat the test with a new
throat swab specimen.
6. Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not read the result after
10 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and
another apparent colored line should be in the test line region (T). A positive result indicates that
Strep A antigen is detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration
of Strep A antigen present in the specimen. Therefore, any shade of color in the test line region
(T) should be considered positive.
Open Valve Position
Positive Negative
ENGLISH
Mark Result Window
Invalid