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Prodesse ProGastro SSCS Assay

  • One test.
  • Five answers.
  • Four hours.

Get there faster with the Health Canada and FDA approved ProGastro SSCS assay.

ProGastro SSCS is for the detection and differentiation of SalmonellaShigellaCampylobacter, (C. jejuni and C. coli only, undifferentiated) nucleic acids and Shiga Toxin 1 (stx1) and Shiga Toxin 2 (stx2) genes. 

 

 

About

When patients are suffering from painful gastroenteritis, they can’t afford to wait —        and neither can you. The ProGastro SSCS assay is a real-time PCR in vitro diagnostic test that delivers accurate, qualitative results for the five most common bacterial gastrointestinal pathogens in just four hours.  The ProGastro SSCS assay can deliver fast answers to guide patient care and help you identify potential outbreaks sooner.

The ProGastro SSCS assay delivers:

Faster time to results

Requires 4 hours versus 24 to 48 hours or longer with culture.

Streamlined workflow

Uses a single protocol to efficiently test for the five most common bacterial gastrointestinal pathogens.

Clear results

Provides accurate qualitative, real-time PCR results for each pathogen.

Minimal disruption     

Runs on third-party lab equipment you may already own. 

Performance Data

ProGastro SSCSCampylobacter (C. jejuni / C. coli) Comparison Results

 

 

Culture

 

 

 

 

Positive

Negative

Total

 

Positive

20

13a

33

Sensitivity 100.0%
(83.9% - 100.0%) 95% CI

Negative

0

1106

1106

Specificity 98.8%
(98.0% - 99.3%) 95% CI

Total

20

1119

1139

 

aSix (6) samples were positive for Campylobacter (C. coli or C. jejuni) by bi-directional sequence analysis.
 

ProGastro SSCS - Salmonella Comparison Results

 

 

Culture

 

 

 

 

Positive

Negative

Total

 

Positive

20

10a

30

Sensitivity 95.2%(77.3% - 99.2%) 95% CI

Negative

1b

1108

1109

Specificity 99.1%(98.4% - 99.5%) 95% CI

Total

21

1118

1139

 

aTen (10) samples were positive for Salmonella by bi-directional sequence analysis.
bOne (1) sample was negative for Salmonella by bi-directional sequence analysis.

 

ProGastro SSCSShigella Comparison Results

 

 

Culture

 

 

 

 

Positive

Negative

Total

 

Positive

15

6a

21

Sensitivity 100.0%
(79.6% - 100.0%) 95% CI

Negative

0

1118

1118

Specificity 99.5%
(98.8% - 99.8%) 95% CI

Total

15

1124

1139

 

                   

aSix (6) samples were positive for Shigella by bi-directional sequence analysis.

 

ProGastro SSCSSTEC Comparison Results

 

 

Broth Enrichment/EIA

 

 

 

 

Positive

Negative

Total

 

Positive

9a

9b

18

Sensitivity 100.0%
(70.1% - 100.0%) 95% CI

Negative

0

1121

1121

Specificity 99.2%
(98.5% - 99.6%) 95% CI

Total

9

1130

1139

 

                   

aSix (6) samples positive for stx1, one (1) sample positive for stx2, and two (2) samples positive for stx1 and stx2 by bi-directional sequence analysis.
bFive (5) samples positive for stx1 and three (3) samples positive for stx2 by bi-directional sequence analysis.

 

ProGastro SSCS - stx1 Comparison Results

 

 

Broth Enrichment/EIA and sequencing
or stx1

 

 

 

 

Positive

Negative

Total

 

Positive

8

6a

14

Positive Percent Agreement 100.0%
 (67.6% - 100.0%) 95% CI

Negative

0

4

4

Negative Percent Agreement 40.0%
(16.8% - 68.7%) 95% CI

Total

8

10

18

 

                   

 

aFive (5) samples were positive for stx1 by bi-directional sequence analysis, but were negative by Broth Enrichment/EIA. 

 

ProGastro SSCS - stx2 Comparison Results

 

 

Broth Enrichment/EIA
and sequencing for stx2

 

 

 

 

Positive

Negative

Total

 

Positive

3

3a

6

Positive Percent Agreement 100.0%
(43.9% - 100.0%) 95% CI

Negative

0

12

12

Negative Percent Agreement 80.0%
(54.8% - 93.0%) 95% CI

Total

3

15

18

 

                   

aThree (3) samples were positive for stx2 by bi-directional sequence analysis, but were negative by Broth Enrichment/EIA.

Regulatory

The Prodesse ProGastro SSCS assay was cleared for in vitro diagnostic use by the FDA in January 2013.

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.