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Products

Syphilis Test
Syphilis Whole Blood Test Strip

Catalog No.          Product Name               

ABT-STD-A60           Anti-Syphilis Whole Blood Strip


INTENDED USE

ACCU-TELL®Rapid Syphilis Test Strip (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 Strip (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®Rapid Syphilis Test Strip (Whole Blood/Serum/Plasma) is >99.9% and the relative specificity is 99.7%.

Method

TPPA

Total Result

Rapid Syphilis Test Strip (Whole Blood/Serum/ Plasma)

Results

Positive

Negative

Positive

200

1

201

Negative

0

319

319

Total Result

200

320

520

Relative Sensitivity: 99.9% (95%CI*: 99.4%-100%)                           

*Confidence Interval

Relative Specificity: 99.7% (95%CI*: 98.3%-100%)

Accuracy: 99.8% (95%CI*: 98.9%-100%)

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®Rapid Syphilis Test Strip (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 Strip (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 Strip (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 Strip (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.