DPP® Syphilis Screen & Confirm

Assay

A Paradigm Shift in Confirmatory Testing for Syphilis Infection

A rapid point-of-care test that simultaneously and separately detects treponemal and nontreponemal antibodies.

Innovative Design • Screens & confirms syphilis infection simultaneously, no need for reflex testing

Easy to Use • Does not require specialized medical training

Actionable • Provides results in 15 minutes, enabling physicians to make treatment decisions

Cost Effective • Reduces overtreatment rate, healthcare patient visits, and cost burden

About Syphilis Infection & DetectionSyphilis is a sexually transmitted disease (STD) caused by the spirochete bacterium Treponema pallidum. According to the World Health Organization, every year about 5.6 million new syphilis infections are acquired.1

The presence of an active syphilis infection can be confirmed by the detection of two distinct anti bodies: treponemal and nontreponemal. The presence of treponemal antibodies can indicate a Treponema pallidum infection, but does not indicate if the infection is active. Presence of nontreponemal antibodies indicates an active infection. Hence, the detection of both treponemal and nontreponemal antibodies simultaneously and separately confirms an active syphilis infection.

Chembio’s DPP® Syphilis Screen & Confirm Assay is unique because it simultaneously and separately detects both treponemal and nontreponemal antibodies, thus confirming an active syphilis infection.

1 http://www.who.int/mediacentre/factsheets/fs110/en/

The Paradigm Shift

FROM MULTIPLE VISITS TO SCREEN & CONFIRM A SYPHILIS INFECTION

TO JUST FIFTEEN MINUTES

PARADIGM SHIFT

Simultaneous detection and confirmation enables immediate treatment to stop the spread of infection.

DPP® Syphilis Screen & Confirm Assay

Product PerformanceRemarkable performance compared to standard laboratory-based algorithms DPP® Syphilis Screen & Confirm Assay showed 99.7% sensitivity in samples with RPR titer of ≥1:8

DPP® Syphilis Screen & Confirm Assay showed a concordance of 96.5% (reactive) and 95.5% (nonreactive) when compared with TP-PA assay

Identical performance of DPP® Syphilis Screen & Confirm and comparator RPR and TP-PA in known untreated syphilis case

Dual Test No. of samples tested with RPR

Nontreponemal Line Reactive Nonreactive Total

Positive 739 11 750

Negative 95* 756 851

Total 834 767 1601

1601 samples were tested with DPP® Syphilis Screen & Confirm Assay and the nontreponemal line was compared with rapid plasma reagin (RPR) test and results are shown above. At RPR titer of ≥1:8, the DPP® Syphilis Screen & Confirm Assay showed a sensitivity of 99.7% and 98.6% specificity.*

*Of the 95 samples missed by DPP® Syphilis Screen & Confirm, most had an RPR titer of 1:1.

Dual Test No. of samples tested with TP-PA

Treponemal Line Reactive Nonreactive Total

Positive 972 27 999

Negative 35 567 602

Total 1007 594 1601

1601 samples were tested with DPP® Syphilis Screen & Confirm and the results of the treponemal line were compared with the comparator TP-PA test.*

Syphilis Category (all untreated)

Total number

of samples

DPP® Syphilis Screen & ConfirmNumber of serum samples reactive

ComparatorNumber of serum samples reactive

Nontreponemal Treponemal RPR Test TP-PA Assay

Reactive Nonreactive Reactive Nonreactive Reactive Nonreactive Reactive Nonreactive

Primary 7 7 0 7 0 7 0 7 0

Secondary 6 6 0 6 0 6 0 6 0

Total 13 13 0 13 0 13 0 13 0

13 well characterized syphilis samples were tested with DPP® Syphilis Screen & Confirm and the results of the Nontreponemal and Treponemal lines were compared with RPR test and TP-PA tests respectively. A 100% concordance of results was seen.*

* Data from package insert

DPP® Syphilis Screen & Confirm Assay

“The sensitivities and specificities of NT and T lines of the Chembio rapid test for syphilis are high, with nearly perfect concordance with the gold standard serology.”

Guinard et at., Usefulness in clinical practice of a point-of-care rapid test for simultaneous detection of NT and T pallidum-specific antibodies in patients suffering from documented syphilis, Intl J of STD & AIDS, 2412, 944-50, 2013

“DPP test shows good sensitivity and specificity in detecting treponemal and nontreponemal antibodies in 3 kinds of specimens.”

Yin et al, Evaluation of Dual POC tests for Syphilis, Clinical Infectious Diseases, 56 (5):659-65, 2013.

“The dual POC tests exhibits remarkable performance characteristics compared to the standard laboratory-based testing algorithm.”

“The use of the dual POC test described here would result in the ability to both screen and confirm the serological status of patients in 15 min and give a better indication of active disease.”

Castro et al., Novel Point-of-Care Test for Simulta-neous Detection of Nontreponemal and Treponemal Antibodies in Patients with Syphilis, Journal of Clinical Microbiology,4615-4619, Dec 2010.

Ordering InformationDescription Catalog Number

DPP® Syphilis Screen & Confirm AssayCE-Marked

65-9520-0

© Copyright 2018, Chembio Diagnostic Systems, Inc. The Chembio logo and DPP are trademarks of Chembio

Diagnostic Systems, Inc. ® Indicates a Chembio trademark registered in the USA. MS-17-016 Rev 2

For More InformationVisit: www.chembio.comCall: 1.844.CHEMBIOEmail: info@chembio.com