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.

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⁾

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.

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⁾

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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®		Latest: July 1, 2026, Rev.4
					Archived: Nov. 1, 2022, Rev.3
FIT Hemoglobin AA01	Reagent 1: 11 mL x 2 Reagent 2: 5 mL x 2 (250 tests/unit)	2-8°C	For AA01
FIT Transferrin NS-Prime	Reagent 1: 33 mL Reagent 2: 13 mL (300 tests/unit)	2-8°C	For NS-Prime®
FIT Transferrin AA01	Reagent 1: 11 mL x 2 Reagent 2: 5 mL x 2 (250 tests/unit)	2-8°C	For AA01
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	Latest: July 1, 2026
				Rev.2	Rev.4	Rev.2	Rev.2	Rev.2
				Archived
				Apr. 1, 2024, Rev.1	Nov. 1, 2022, Rev.3	Apr. 1, 2024, Rev.1	Apr. 1, 2024, Rev.1	Apr. 1, 2024, Rev.1
FIT Hemoglobin NS-Prime Calibrator	1 mL x 4 vials (lyophilized) Calibrator Solution: 12 mL	2-8°C	For NS-Prime® and AA01	Latest: July 1, 2026
				Rev.2	Rev.4	Rev.2	Rev.2	Rev.2
				Archived
				Apr. 1, 2024, Rev.1	Nov. 1, 2022, Rev.3	Apr. 1, 2024, Rev.1	Apr. 1, 2024, Rev.1	Apr. 1, 2024, Rev.1
FIT Transferrin NS-Prime Calibrator	1 mL x 4 vials (lyophilized) Calibrator Solution: 12 mL	2-8°C	For NS-Prime® and AA01
Specimen Collection Container A	400 pcs.	1-30°C	For NS-Prime® and AA01
	500 pcs.
Wash Solution A	500 mL x 2	1-30°C	For NS-Prime® and AA01
FIT NS-Prime Specimen Diluent	13 mL x 2	2-8°C	For NS-Prime®	Latest: July 1, 2026
				Rev.3	Rev.4	Rev.3	Rev.3	Rev.3
				Archived
				Nov. 1, 2023, Rev.2	Nov. 1, 2022, Rev.3	Nov. 1, 2023, Rev.2	Nov. 1, 2023, Rev.2	Nov. 1, 2023, Rev.2
FIT AA01 Specimen Diluent	8 mL x 2	2-8°C	For AA01	Latest: July 1, 2026		Latest: July 1, 2026	Latest: July 1, 2026
				Rev.3		Rev.3	Rev.3
				Archived		Archived	Archived
				Nov. 1, 2023, Rev.2		Nov. 1, 2023, Rev.2	Nov. 1, 2023, Rev.2

In Preparation

• FIT

  

• FIT Publications

  

• Analyzers

  

• Calprotectin