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Diagnostics Direct

Syphilis Health Check™ Test

Syphilis Health Check™ Test

1 box contains these components:

  • 20 test cassettes, individually packed in sealed pouches
  • 20 disposable plastic fixed volume pipettes (for whole blood only) packed in one pvc re-sealable bag
  • 1 diluent dropper bottle - saline buffer, detergent and sodium azide (NaN3, 0.1%) (5ml)
  • 1 IFU (instruction for use) leaflet
  • 1 Quick Reference Guide

1 master case = 76 boxes

1 pallet = 24 master cases or 12 master cases

 

Intended use statement: 

Syphilis Health Check is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood, serum or plasma. This product can be used as an initial screening test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. 

This test is not intended for use in screening blood or plasma donors.

 

In short:

Syphilis Health Check 

Syphilis Antibody Rapid Immunochromatographic Test

Rapid qualitative screening for human Treponema Pallidum (Syphilis) TP antibodies in Whole Blood, Serum or Plasma

 

 First and only CLIA Waived rapid treponemal syphilis test:

    CLIA Waived for Whole Blood – Finger Stick

    CLIA Moderately Complex for Whole Blood, Serum or Plasma

Simple 2 Step Procedure

Results in 10 Minutes

High Accuracy >97%*, even with untrained testers

 For in vitro diagnostic use only

Room temperature storage

 510(k) number K102400 

CPT code: 86780 QW

 National Average Medicare Published Rate: $13.24

 

*Agreement to reference methods – see P.I. CLIA studies

Performance:

Percent Positive Agreement: 94.9% (95% C.I. = 92.4 - 96.8%) 

Percent Negative Agreement: 93.3% (95% C.I. = 91.3 - 95.0%) 


Notice: This product must be drop shipped by the manufacturer, and therefore might take longer to arrive than a product directly shipped by Verséa.

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