Alfresa Pharma Corporation

Features of Our FIT Hemoglobin and FIT Transferrin Products

How Colloidal Gold Agglutination Works

The conventional fecal occult blood test uses a chemical to perform the test, such as guaiac test (g-FOBT). However, our FIT Hemoglobin and Trasnferrin products use an immunoassay that reacts specifically to human hemoglobin/transferrin, eliminating the need for dietary restrictions before the test. In addition, our products use a colloidal gold agglutination method that optically measures color and turbidity changes caused by antigen-antibody reactions at two different wavelengths, and they are highly accurate and sensitive.

Measurement principle: Colloidal gold agglutination1)

Innovative Specimen Collection Container A
[Easy to use and excellent hemoglobin stability after sampling]

The stability of hemoglobin was excellent in the Specimen Collection Container A, and after sampling, the samples (50–381 ng/mL) remained negative or positive (cut-off value: 100 ng/mL) for 33 days at -40℃ and -7℃, for 14 days at 25℃, and for 7 days at 37℃.2)

Hemoglobin stability after sampling2)

-40°C, for 33 days -7°C, for 33 days 25°C, for 14 days 37°C, for 7 days
50 ng/mL > 90% > 90% > 90% > 90%
169 ng/mL > 90% > 90% > 90% > 70%
266 ng/mL > 90% > 90% > 70% > 50%*
381 ng/mL > 90% > 90% > 50%* > 30%*
  • Hb residual ratios decreased to 37-55%, but the results were still positive (cut-off: 100 ng/mL).
    This result is provided for reference only. The stability varies depending on the specimen.

The Specimen Collection Container A is flat and rectangular in shape and easy to handle, and has high structural strength1) to withstand shocks during transportation. After fecal sampling, the aqua blue buffer solution turns green, which camouflages the fecal color and eases the user’s discomfort and serves as a useful indicator to show that the user has taken a fecal sample.

Features of Specimen Collection Container A1)

Usefulness of Transferrin
[Simultaneously measured with hemoglobin with the same Specimen Collection Container A]

The efficacy of the fecal immunochemical test (FIT) has been established. However, hemoglobin, the substance to be measured, may become inactivated by the bacteria in the large intestine if it remains in the large intestine for a long time, and this instability may result in false negatives. Transferrin in the stool is one of the blood components and is relatively stable against the bacteria in the large intestine. Accordingly, measuring transferrin simultaneously with hemoglobin provides more accurate information on bleeding in the large intestine and decreases the risk of oversight due to false negative with hemoglobin.3) This simultaneous assay can be expected to show higher accuracy and efficacy in colorectal cancer screening.4)

References

  • 1)Data on file: Alfresa Pharma Corporation
  • 2)Instructions for use: Alfresa Pharma Corporation
  • 3)Uchida K, et al. A new immunochemical fecal occult blood test--combination assay of hemoglobin and transferrin. Rinsho Byori. 1989; 37: 58-62. [Article in Japanese]
  • 4)Hirata I. Evaluation of the usefulness of the simultaneous assay of fecal hemoglobin (Hb) and transferrin (Tf) in colorectal cancer screening - for the establishment of the Hb and Tf two-step cutoff assay (HTTC assay). Diagnosis (Berl). 2020 May 26;7(2):133-139.

Product Information

Product Unit Storage Notes IFU
FIT Hemoglobin NS-Prime Reagent 1: 33 mL x 4
Reagent 2: 13 mL x 4
(1,200 tests/unit)
2-8°C For NS-Prime®
FIT Hemoglobin AA01 Reagent 1: 11 mL x 2
Reagent 2: 5 mL x 2
(250 tests/unit)
2-8°C For AA01 TBA TBA TBA
FIT Transferrin NS-Prime Reagent 1: 33 mL
Reagent 2: 13 mL
(300 tests/unit)
2-8°C For NS-Prime® TBA TBA TBA
FIT Transferrin AA01 Reagent 1: 11 mL x 2
Reagent 2: 5 mL x 2
(250 tests/unit)
2-8°C For AA01 TBA TBA TBA
FIT NS-Prime Control L: 2 mL x 5 vials (lyophilized)
H: 2 mL x 5 vials (lyophilized)
Control Solution: 30 mL
2-8°C For NS-Prime® and AA01
FIT Hemoglobin NS-Prime Calibrator 1 mL x 4 vials (lyophilized)
Calibrator Solution: 12 mL
2-8°C For NS-Prime® and AA01
FIT Transferrin NS-Prime Calibrator 1 mL x 4 vials (lyophilized)
Calibrator Solution: 12 mL
2-8°C For NS-Prime® and AA01 TBA TBA TBA
Specimen Collection Container A 500 pcs. 1-30°C For NS-Prime® and AA01
Wash Solution A 500 mL x 2 1-30°C For NS-Prime® and AA01 TBA TBA
FIT NS-Prime Specimen Diluent 13 mL x 2 2-8°C For NS-Prime®
FIT AA01 Specimen Diluent 8 mL x 2 2-8°C For AA01 TBA TBA TBA
ALL

TBA: to be announced

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