4mm Cassette Infectious Disease Blood Tests , Tetanus Test For Blood Infection

One Step 4mm Cassette Tetanus Rapid Test , for detection of antibodies to Tetanus, gold colloidal method

Product Name: One Step Tetanus Rapid Diagnostic Test Cassette

Intended Use:

The Tetanus Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Tetanus toxin in whole blood, serum, or plasma to aid in the diagnosis of Tetanus toxin infection.

Summary:

Clostridium tetani is a bacterium that causes tetanus in humans. Clostridium tetani ate Gram-positive, spore-forming rods that are anaerobic. If they enter the body through a wound, they can multiply and produce a toxin that affects the nerves and controls the activity of muscles. Toxin of Clostridium tetani binds to membranes of peripheric nervous cells and inhibits the release of neurotransmitters.

Antibodies to tetanus toxin are produced in the human by the injection of chemically inactivated tetanus toxin (tetanus toxoid). Immunization is the best way to prevent C. Tetani infections in children and adults. Moreover, injection of specific and purified anti tetanus toxin IgG is used in order to refrain toxin action during an acute infection.It is sometimes better to know the level of anti tetanus toxin antibodies in a patient, to evaluate their immune status, in order to determine the necessity of a complementary vaccination which would assure immunity towards tetanus toxin.In emergency situations, it is important for the clinician to know the immune status in order to decide on the correct anti-tetanus prophylaxis for high risk patients (deep wounds).

TEST PRINCIPLE

The Tetanus Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane based immunoassay for the detection of Tetanus Toxin antibodies in whole blood, serum, or plasma. In this test procedure, purified tetanus toxoid (a non-pathogenic derivative of tetanus toxin) is immobilized in the test line region of the test. After specimen is added to the specimen well of the device, it reacts with Tetanus toxoid coated particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the purified tetanus toxoid. If the specimen contains tetanus antibodies, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain tetanus antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret 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 Sensitivity, Specificity and Accuracy

A total of 596 specimens were tested by Tetanus Rapid Test Cassette (Whole Blood/Serum/Plasma) and Tetanus ELISA test, both of them could detect 128 positive results and 455 negative results, sensitivity of Tetanus Rapid Test Cassette was 94.1%, specificity of the test was 98.9%.

Sensitivity and Specificity

Relative Sensitivity: 94.1% (95%CI*: 88.7%-97.4%) *Confidence Interval

Relatively Specificity: 98.9% (95%CI*: 97.5%-99.6%)

Accuracy: 97.8% (95%CI*: 96.3%-98.8%)