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Products

Syphilis Test
Syphilis Whole Blood Test Cassette

Catalog No.       Product Name

ABT-STD-B60   Syphilis Whole Blood Test Cassette


INTENDED USE

ACCU-TELL® Rapid Syphilis Test 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.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid Syphilis Test Cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of a seroconversion 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® Rapid Syphilis Test Cassette (Whole Blood/Serum/Plasma) is >99.9%, and the relative specificity is 99.7%.

Method

TPPA

Total Result

ACCU-TELL® Rapid Syphilis Test 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 15 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 15 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® Rapid Syphilis Test 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® Rapid Syphilis Test 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® Rapid Syphilis Test 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® Rapid Syphilis Test 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.