One Step High accuracy Strep B Rapid Diagnostic test , quick and easily, gold colloidal method,swab specimen

Product Name: One Step Strep B Rapid Diagnostic test

Accessories:

Intended Use:

The Strep B Rapid Test Cassette (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Group B Streptococcus (GBS) antigens in specimens taken from vaginal or rectal swaps of pregnant women, or general swabs from newborn. This kit is intended for use as an aid in the diagnosis of Strep B infection.

Summary:

Group B Streptococci (GBS) or Streptococcus agalactiae are among the most frequent causes of life-threatening infectious in neonates. Between 5% and 30% of all pregnant women are colonized with GBS.1Several recent studies have shown that the intrapartum treatment of GBS-colonized women significantly reduces the incidence of GBS-caused sepsis.2-4 The US Center for Disease Control and Prevention (CDC) recommends routine examination for Group B streptococcus between the 35th and the 37th week of pregnancy. A CDC study has shown that routine examinations is 50% more effective than the use of antibiotics for pregnant women with clinical risk factors.

Standard culture methods require 24 to 48 hours, and the results may not be available soon enough for efficient treatment. Thus, methods utilizing more rapid screening techniques are required.

TEST PRINCIPLE

The Strep B Rapid Test Cassette (Swab) detects Group B Streptococcus antigens through visual interpretation of color development on the internal strip. Anti-Strep B antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with polyclonal anti-Strep B antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is sufficient Strep B antigen in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Hold the Extraction Reagent 1 bottle vertically and add 4 full drops (approximately 240 μl) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red in color. Hold the Extraction Reagent 2 bottle vertically and add 4 full drops (approximately 160 μl) to the tube. Extraction Reagent 2 is colorless. Mix the solution by gently swirling the extraction tube. The addition of Extraction Reagent 2 to Extraction Reagent 1 changes the color of the solution from red to yellow.
3. Immediately add the swab into the extraction tube, agitate the swab vigorously 15 times, leave the swab in the extraction test tube for2 minutes.
4. Press the swab against the side of the tube and squeeze the bottom of the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab.
5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface.
6. Add 3 full drops of the extracted solution (approx. 150μl) to the specimen well of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.Wait for the color to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

PERFORMANCE CHARACTERS:

Clinical Study

The Strep B Rapid Test Cassette (Swab) has been evaluated with specimens obtained from patients of STD clinics. Culture is used as the reference method for the Strep B Rapid Test Cassette (Swab). Specimens were considered positive if culture indicated a positive result. Specimens were considered negative if culture indicated a negative result.

Relative Sensitivity: 95.2% (95%CI:*89.6%-98.2%)

Relative Specificity: 97.8% (95%CI:*95.8%-99.0%)

Overall accuracy: 97.2% (95%CI:*95.3%-98.4%) *Confidence Intervals

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.