Alfresa Pharma Corporation

Features of Our NESCAUTO® Cp Auto Products

How Colloidal Gold Agglutination Works

The conventional fecal calprotectin test often uses the ELISA method. However, our NESCAUTO® Cp Auto products use a colloidal gold agglutination method, which is an immunoassay. The gold colloid agglutination method optically measures the color change caused by antigen-antibody reactions at two different wavelengths, and therefore, it is highly accurate and sensitive.1)

Measurement principle: Colloidal gold agglutination2)

No Sample Preparation Required
[Easy and quick use]

Compared to the conventional ELISA method, our NESCAUTO® Cp Auto products do not require sample preparation, which enables easy and quick use. The measurement time is as short as 10 to 15 minutes, allowing both the patient and the doctor to discuss and consult on the treatment policy together (shared decision making) after the patient is informed of the results on the day of the test, which is also beneficial as it leads to proactive treatment (improving adherence).

Steps of ELISA and NESCAUTO® Cp Auto products2)

Usefulness of Simultaneous Multiple Assay

Not only calprotectin but also hemoglobin in the fecal samples can be measured simultaneously from a sample obtained in a single Specimen Collection Container A, and therefore, disease activity can be assessed from the perspectives of both inflammation (calprotectin) and bleeding (hemoglobin).3)

Excellent Correlation with ELISA / Endoscopy Results

A strong correlation has been observed between the fecal calprotectin levels measured using our NESCAUTO® Cp Auto products and those measured using the conventional ELISA method (r = 0.98, p < 0.01). And, a strong correlation was observed in the colonoscopy findings [r = 0.70, p < 0.01 for ulcerative colitis (UC); r = 0.58, p < 0.01 for Crohn’s disease (CD)].4) In addition, high sensitivity and specificity can be expected for both UC and CD.4)

References

  • 1)Okuyama Y, et al. A novel sol particle immunoassay for fecal calprotectin in inflammatory bowel disease patients. Clin Chim Acta. 2016 May 1;456:1-6.
  • 2)Data on file: Alfresa Pharma Corporation
  • 3)Mooiweer E, et al. Fecal hemoglobin and calprotectin are equally effective in identifying patients with inflammatory bowel disease with active endoscopic inflammation. Inflamm Bowel Dis. 2014; 20(2): 307-314.
  • 4)Inoue K, et al. Usefulness of a novel and rapid assay system for fecal calprotectin in pediatric patients with inflammatory bowel diseases. J Gastroenterol Hepatol. 2014;29(7):1406-12.

Product Information

Product Unit Storage Notes IFU
NESCAUTO Cp Auto NS-Prime Reagent 1: 31 mL x 2
Reagent 2: 11 mL x 2
(400 tests/unit)
2-8°C For NS-Prime® TBA TBA
NESCAUTO Cp Auto AA01 Reagent 1: 12 mL x 2
Reagent 2: 5.5 mL x 2
(150 tests/unit)
2-8°C For AA01 TBA TBA
NESCAUTO Cp Auto Control L: 3 mL x 4 vials
H: 3 mL x 4 vials
2-8°C For NS-Prime® and AA01 TBA TBA
NESCAUTO Cp Auto Calibrator 1 mL x 4 vials
Calibrator Diluent: 12 mL
2-8°C For NS-Prime® and AA01 TBA TBA
Specimen Collection Container A 500 pcs. 1-30°C For NS-Prime® and AA01 TBA TBA
Wash Solution A 500 mL x 2 1-30°C For NS-Prime® and AA01 TBA TBA TBA
FIT NS-Prime Specimen Diluent 13 mL x 2 2-8°C For NS-Prime® TBA TBA TBA
FIT AA01 Specimen Diluent 8 mL x 2 2-8°C For AA01 TBA TBA TBA
ALL TBA TBA

TBA: to be announced

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