DPP® Zika IgM System

A 15 minute rapid test for detecting Zika virus infection

For Use Under Emergency Use Authorization (EUA) Only*

DPP Zika IgM System

Description

For the detection of Zika virus IgM antibodies in fingerstick whole blood, EDTA venous whole blood, EDTA plasma and serum

Key features

  • Fast: Provides results in as little as 15 minutes
  • Flexible: Detects Zika virus IgM antibodies from 8 days up to 12 weeks
  • Easy to use: Provides objective results using simple, handheld digital reader (DPP® Micro Reader)

Product performance

Wide testing window

DPP® Zika IgM Assay System detected Zika antibodies as early as day 8 and reliably detected for approximately 12 weeks1

DPP Zika IgM Detection Window

DPP® Zika IgM Assay System vs. laboratory-based serological assays2

DPP Zika IgM Assay vs lab

Days Post Onset of Symptoms (weeks)% Detected (# Reactive/ Total)
DPP® Zika IgM Assay SystemTest 1Test 2Test 3
0-7
( <=1 wk)
32.1%
(17/53)
20.7%
(11/53)
38%
(20/52)
17%
(7/41)
8-83
( >1-12 wks)
99.7%
(343/344)
82.8%
(285/344)
90.2%
(314/348)
93.3%
(139/149)

Serial samples from 50 confirmed Zika-positive cases were tested using DPP® and other lab-based assays.1

Showed equivalent specificity across all blood matrices

Matrix% concordance with presumed negative samples
Fingerstick whole blood100% (102/102)
EDTA venous whole blood98% (239/244)
EDTA Plasma 100% (89/89)
Serum98% (583/594)
DPP® Zika IgM Assay System showed equivalent specificity across all blood matrices.1

1Data from package insert
2Authorized under EUA by FDA

Order Information

Product NameContentsCatalog number
DPP® Zika IgM Assay SystemEach kit contains the items to perform 20 tests:
- 20 Individually Pouched DPP® Zika IgM Test Devices
- 20 Disposable 10 µL Microsafe®Tubes
- 20 Sample Vials
- 20 Transfer Pipets (100 µL)
- 1 DPP® IgM Sample Buffer - Blue Cap
- 1 DPP® IgM Running Buffer - Yellow Cap
- 1 Authorized Product Insert
65-9555-0
DPP® Micro Reader - 1 DPP® Micro Reader (includes 3 Lithium Batteries)
- 1 Holder for use with DPP® Zika IgM System Test Device
- 1 USB Cable
- 1 User Manual
61-1070-0
DPP® Zika IgM Assay Control Pack1 DPP® Zika Reactive Control
1 DPP® Zika Nonreactive Control
62-1001-0

*FDA Conditions for Authorization

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the diagnosis of Zika virus infection and not for any other viruses or pathogens; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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