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Accu-Tell® Single Drug of Abuse Rapid Test Cassette (Saliva)

Single Drug Urine Rapid Test

Accu-Tell® Single Drug of Abuse Rapid Test Cassette (Saliva) is a One Step chromatographic immunoassay for the detection of drugs in human saliva at the cut-off concentrations.

CATALOG

TEST PROCEDURE of Single Drug-Of-Abuse Test 

Allow the test cassette, specimen, and/or controls to reach room temperature (15-30ºC) prior to testing. Instruct the donor to not place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2. Remove the collector from the sealed pouch and insert the sponge end of the collector into the mouth. Actively swab the inside of the mouth and tongue to collect Saliva for a total of 3 minutes until the sponge becomes fully saturated.  Gentle pressing the sponge between the tongue and teeth will assist saturation. No hard spots should be felt on the sponge when saturated.

3. Remove the collector from the mouth. Place saturated Saliva collector into chamber and press sponge fully against the strainer to collect Saliva.  Discard the collector.  Snap the cap shut on the collection chamber.

4. Place the test cassette on a clean and level surface.  Unscrew cap cover from the collection chamber.  Invert the collection chamber and transfer 3 drops of Saliva (approximately 120 µL) into specimen well of the test cassette and start the timer.  Avoid trapping air bubbles in the specimen well.  Place screw cap on the collection chamber.  See illustration below.

5. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not read results after 1 hour. We also produce Rapid Test Saliva Cup and Saliva Rapid Test Cassette.

LIMITATIONS

1. ACCU-TELL® Single Drug of Abuse Rapid Test Cassette (Saliva) provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method.

2. A positive result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in saliva.

3. A negative result may not necessarily indicate drug-free saliva. Negative results can be obtained when drug is present but below the cut-off level of the test.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.

Infectious Disease Tests

12.

Accu-Tell® HAV IgM Rapid Test Cassette (Serum/Plasma)

Accu-Tell® HAV IgM Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis A virus (HAV) in serum or plasma.

HAV Rapid Test

CATALOG

KEY POINTS

Detection for: IgM anti-HAV in serum or plasma;

Specimen volume: 50 μl;

Reading time: 20 minutes;

Relative Sensitivity: >99.9% (95%CI*: 88.7%-100%);

Relative Specificity: 99.1% (95%CI*: 96.8%-99.9%);

Accuracy: 99.2% (95%CI*: 97.1%-99.9%).

INTRODUCTION of China Infectious Disease Tests

HAV is a positive RNA virus, a unique member of picornavirdae. Its transmission depends primarily on serial transmission from person to person by the fecal-oral route. Although hepatitis A is not ordinarily a sexually transmitted disease, the infection rate is high among male homosexuals, as result of oral-anal contact.

The presence of specific anti-HAV IgM in blood samples s ests acute or recent HAV infection. The IgM antibody rapidly increases in titer over a period of 4-6 weeks post infection, and then declines to non-detectable levels within 3 to 6 months in most patients.

INTENDED USE

ACCU-TELL® HAV IgM Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis A virus (HAV) in serum or plasma.

TEST PROCEDURE 

1. Sample dilution: Add 50μl HAV serum or plasma into the sample dilution bottle first, then mix the solution plenty.

2. Remove the test cassette from sealed pouch and used it within one hour. Best results will be obtained if the assay is performed immediately after opening foil pouch.

3. Hold the dropper vertically, draw the sample dilution up to the Fill Line as shown in illustration below (approximately 5μL).Then transfer the  sample dilution to the sample port (S) which part have been marked. Or using micropipette add 5μl dilution sample into the sample port (S) which part have been marked.

4. Add 2 drops of buffer (approx. 80μl) into the dilution well (B) of the test cassette, start the time.

5. Read the results at 20 minutes; do not interpret after 20 minutes

PERFORMANCE CHARACTERISTICS of Infectious Disease Tests

Sensitivity and Specificity

ACCU-TELL® HAV IgM Rapid Test Cassette (Serum/Plasma) was compared with a leading commercial ELISA HAV IgM test; the results show that ACCU-TELL® HAV IgM Cassette (Serum/Plasma) has a high sensitivity and specificity.

Relative Sensitivity: >99.9% (95%CI*: 88.7%-100%)

Relative Specificity: 99.1% (95%CI*: 96.8%-99.9%)

Accuracy: 99.2% (95%CI*: 97.1%-99.9%)

*95% Confidence Intervals

LIMITATIONS

1. The Assay Procedure and the Assay Result Interpretation must be followed closely when testing the presence of anti-HAV IgM in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.

2. ACCU-TELL® HAV IgM Rapid Test Cassette (Serum/Plasma) is limited to the qualitative detection of anti-HAV IgM in human serum or plasma. The intensity of the test band does not have linear correlation with the antibody titer in the specimen.

3. A negative result for an individual subject indicates absence of detectable anti-HAV IgM. However, a negative test result does not preclude the possibility of exposure to or infection with HAV.

4. A negative result can occur if the quantity of the anti-HAV IgM present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

5. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.

6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings. We are also IgG Rapid Test Cassette Supplier.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.