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Accu-Tell® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma)

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Accu-Tell® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.
Product Description

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

Syphilis Strip

Whole Blood/Serum/Plasma

ABT-STD-A60

100T/40T

CE

Syphilis Cassette

Whole Blood/Serum/Plasma

ABT-STD-B60

40T/20T

CE


KEY POINTS

Detection for: antibodies (IgG and IgM) to Treponema Pallidum (TP) qualitatively in whole blood.Serum or plasma.

Specimen volume:

For test strip: Serum or Plasma Specimen: 50μL

                        Venipuncture or Fingerstick Whole Blood specimen: 50μL

For test cassette:  Serum or Plasma specimen:40μL

                                Venipuncture or Fingerstick Whole Blood Specimen:80μL

Reading time: 10 minutes

Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);  

Relative specificity: 99.7% (95%CI*: 98.2%~100.0%);

Accuracy: 99.8% (95%CI*: 98.2%~100.0%).      


INTRODUCTION

Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane.  Relatively little is known about the organism in comparison with other bacterial pathogens.

 

INTENDED USE

ACCU-TELL® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.

 

TEST PROCEDURE

Test strips:

Syphilis strip WSP.png

Test Cassette:

Syphilis strip WSP.png

1. Remove the test strip from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Peel off the tape from the test card, and stick the test strip in middle of the test card with arrows pointing downwards as illustrated.

3. Place the Strip/Cassette on a clean and level surface.

For test strip

For Serum or Plasma specimen: Hold the dropper vertically and transfer 2 drop of serum or plasma (approximately 50μL) to the Specimen Pad of the test strip, then add 1 drop of buffer (approximately 40μL) and start the timer.

For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) onto the Specimen Pad of the test strip, then add 1 drop of buffer (approximately 40μL), and start the timer.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 50 μL of fingerstick whole blood specimen to the specimen area of test strip, then add 1 drop of buffer (approximately 40μL) and start the timer.

For test cassette:

For Serum or Plasma specimen:

Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40μL) to the specimen area, then add 1 drop of buffer (approximately 40μL),and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80μL) to the specimen area, then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 80μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.

4. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 30 minutes.


PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of a performance panel and has been compared to a leading commercial TPPA Syphilis test using clinical specimens. The results show that the relative sensitivity of ACCU-TELL® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) is >99.9% and the relative specificity is 99.7%.

Method

TPPA

Total Result

ACCU-TELL®   Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma)

Results

Positive

Negative

Positive

130

1

131

Negative

0

299

299

Total Result

130

300

430

Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);

Relative specificity: 99.7% (95%CI*: 98.2%~100.0%);

Accuracy: 99.8% (95%CI*: 98.2%~100.0%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of four specimens: a negative, a low positive, a medium positive and a high positive. The negative, low positive, medium positive and high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 10 independent assays on the same four specimens: a negative, a low positive, a medium positive and a high positive. Three different lots of ACCU-TELL® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) have been tested over a 3-day period using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV,HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to Syphilis negative and positive specimens.

Acetaminophen:          20 mg/dL                       Caffeine:          20 mg/dL

Acetylsalicylic Acid:      20 mg/dL                      Gentisic Acid:   20 mg/dL

Ascorbic Acid:                    2g/dL                       Albumin:               2 g/dL

Creatin:                      200 mg/dL                       Hemoglobin    1.1 mg/dL

Bilirubin:                             1g/dL                       Oxalic Acid:     600mg/dL

None of the substances at the concentration tested interfered in the assay.

 

LIMITATIONS

1. ACCU-TELL® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of TP antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in TP antibodies can be determined by this qualitative test.

2. ACCU-TELL® Syphilis Rapid Test Strip/Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of TP antibodies in the specimen and should not be used as the sole criteria for the diagnosis of TP infection.

3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of TP infection.

 

 

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