Chembio Diagnostics, Inc

DPP HIV-Syphilis, 20 tests/kit (CDI 65-9502-0)

Name: DPP HIV-Syphilis, 20 tests/kit (CDI 65-9502-0)
Brand: Chembio Diagnostics, Inc
SKU: CDI 65-9502-0
Price: 315 USD
Availability: InStock

SKU: CDI 65-9502-0

UNIT

QUANTITY

Kit

1 Kit (20 tests/kit)

$315.00

QUALITY CERTIFIED

FAST SHIPPING

RELIABLE FULFILLMENT

Internal SKU

CDI 65-9502-0

Brand Name

Chembio Diagnostics, Inc

Description

DPP HIV-Syphilis, 20 tests/kit (CDI 65-9502-0)

An FDA Approved, CLIA Waived dual rapid test for the detection of antibodies to HIV 1/2 and Treponema pallidum in fingerstick whole blood, venous whole blood, or plasma specimens.

Reliable

Patented DPP technology allows for higher sensitivity: >99% for HIV and >94% for T. pallidum
Built-in procedural control

Easy to Use

Small sample volume: 10 μl
15 minute dual rapid test
Provides objective results using simple, handheld digital reader (DPP Micro Reader)

Economical

Combined reimbursement: CPT Codes 86703, 86780
Ideal as the first line rapid test in your algorithm

Manufacturer #	65-9502-0
Brand	DPP
Manufacturer	Chembio Diagnostic
Country of Origin	USA
Application	Sexual Health Test Kit
CLIA Classification	CLIA Waived
Contents	(20) Individually Pouched DPP HIV-Syphilis Test Devices each with Desiccant Pouch (20) Disposable 10 µL Sample Loops with Break Point (20) DPP SampleTainer Bottles (1) DPP Running Buffer (1) Product Insert
Number of Tests	20 Tests
Reading Type	Machine Read
Sample Type	Whole Blood / Plasma Sample
Specialty	Molecular
Test Format	Cassette Format
Test Kit Type	Rapid Test
Test Name	HIV-Syphilis
Test Type	Antibody Test
Time to Results	15 Minute Results

Product	Catalog Number
DPP HIV-Syphilis (20 tests) FDA Approved	65-9502-0
DPP HIV-Syphilis Rapid Test Control Pack	65-9555-0
DPP Micro Reader for Use with DPP HIV-Syphilis	70-1056-0

FAQ:

Are there other confirmatory tests needed when using these rapids?

In the reverse testing algorithm for syphilis, you will need to reflex to RPR to find out if you have an active or past infection. For HIV you would need to confirm a positive based on your site’s protocols.

Could temperature be a factor when using this test in the field or on the street?

The test components should be at room temperature, 18 to 25 C (64 to 77 F), before performing the test and the test should be performed within the same temperature range. If the temperature of the testing area falls outside of 18 to 25 C (64 to 77 F) it is recommended to perform QC prior to testing.

Is it possible to visually interpret the test?

No. The test must be read using the DPP Micro Reade r.

Is there any data regarding efficacy with pregnant patients?

Yes, we Chembio has multiple sets of data in our IFU that addresses the test performance in this population of patients.

Is this test 4^th generation for HIV?

We do not detect antigen to HIV, just antibodies to HIV, the following papers support this approach to the rapid HIV Testing.

The paper ‘Field Accuracy of fourth Generation Rapid Test’ by Lewis et al analyzed 4 studies that included 17,381 samples screened using 4th generation (Antigen-Antibody) rapid tests.

Findings:

26 reference-standard-defined acute HIV infections were missed
35 false positives were observed

Lesson’s Learned: ‘Fourth-generation RDTs are currently unsuitable for the detection of acute HIV-1’ at the point of care.

Why the Poor Test Performance: The assay detects free HIV-1 p24 antigen. This has a short window of detection. “Antibodies form immune complexes with antigen in the bloodstream and preclude binding of antigen to the test strip. This technical difficulty can be overcome with an antigen dissociation step, but this may be hard to implement at the point of care.”

Is the concern for syphilis biological false positive the same as with traditional testing?

The term “biological false positive” for syphilis is defined as a positive reaction to regain tests (non-trep), but negative reaction to treponemal tests. Non-trep such as RPR, are looking for anti-cardiolipin antibodies which are not specifically associated with treponemal infections, so having a positive RPR and negative Treponemal test is what is usually referred to as a biological false positive when the traditional algorithm is used.