Fecal Hemoglobin and Fecal Transferrin Rapid Tests

Two complementary tests. One stool specimen. Broader assessment of occult gastrointestinal bleeding.

The Fecal Hemoglobin Rapid Test and Fecal Transferrin Rapid Test are separate, individually packaged lateral-flow tests designed to detect microscopic blood-related biomarkers in human feces.

Although each test is supplied and performed separately, healthcare professionals may use them together as a dual-biomarker screening approach. Testing for both hemoglobin and transferrin can provide additional information compared with testing for either biomarker alone.

Occult gastrointestinal bleeding may occur in conditions such as colorectal polyps, colorectal cancer, ulcers, inflammatory bowel disease, diverticular disease and other gastrointestinal disorders. A positive result does not diagnose cancer, but indicates that further clinical evaluation may be required.

Important Product Information

These products are sold in separate packages.

Each package contains its own:

• Test cassette
• Specimen collection and extraction system
• Buffer, where provided
• Package insert
• Lot number and expiry date

A single stool specimen may be collected and sampled into the separate specimen collection tubes supplied with each kit. The buffers, collection tubes or extracted specimens should not be mixed unless specifically validated and authorised in the product instructions.

Why Test Hemoglobin and Transferrin Together?

Complementary biomarkers of gastrointestinal bleeding

Fecal Hemoglobin—Hb

Hemoglobin is a major blood protein commonly detected by fecal immunochemical testing. Its detection can indicate microscopic gastrointestinal bleeding and is particularly useful within lower gastrointestinal and colorectal screening pathways.

Fecal Transferrin—Tf

Transferrin is another blood-derived protein. It is considered more stable than hemoglobin under some gastrointestinal and fecal conditions and may remain detectable when hemoglobin has partially degraded.

Combined clinical value

Parallel testing may:

• Increase the opportunity to identify different patterns of occult gastrointestinal bleeding.
• Provide complementary information when one biomarker is detectable and the other is not.
• Strengthen evidence of bleeding when both tests are positive.
• Support colorectal cancer screening, gastrointestinal assessment and referral decisions.
• Help healthcare professionals identify patients requiring further clinical investigation.

The tests detect evidence of bleeding; they do not identify its exact source or independently diagnose colorectal cancer.

Intended Use

Fecal Hemoglobin Rapid Test

A lateral-flow immunoassay intended for the qualitative detection of human hemoglobin in fecal specimens.

It may be used by healthcare professionals as an aid in identifying occult gastrointestinal bleeding and within appropriate colorectal cancer screening or gastrointestinal assessment pathways.

Fecal Transferrin Rapid Test

A lateral-flow immunoassay intended for the qualitative detection of human transferrin in fecal specimens.

It may be used as an aid in the assessment of gastrointestinal bleeding and as a complementary test alongside fecal hemoglobin testing.

Intended users

• Hospitals and clinics
• Diagnostic laboratories
• Gastroenterology and oncology services
• Health-screening centres
• Physician offices
• Public-health screening programmes

For professional and in-vitro diagnostic use only.

Test Principle

Both products use lateral-flow immunochromatographic technology.

The test membrane contains antibodies directed against the relevant target biomarker:

• Anti-human hemoglobin antibodies in the Hb test
• Anti-human transferrin antibodies in the Tf test

After the extracted fecal specimen is added to the specimen well, the liquid migrates along the membrane by capillary action.

When the target biomarker is present at or above the test’s detection threshold, it reacts with antibody-coated particles and forms a visible coloured line in the test region—T.

A coloured line in the control region—C confirms that:

• Adequate specimen volume was applied.
• Membrane migration occurred correctly.
• The test procedure functioned as intended.

Recommended Dual-Test Workflow

One stool specimen, two independent tests

1. Collect a fresh stool specimen in a clean, dry collection container.
2. Open the specimen collection tube supplied with the hemoglobin test.
3. Sample the stool according to the Hb kit instructions.
4. Repeat the sampling procedure using the separate tube supplied with the transferrin test.
5. Mix each collection tube independently.
6. Apply the extracted sample from each tube to its corresponding cassette.
7. Read and record each test independently.
8. Interpret the Hb and Tf results together with symptoms, medical history and other clinical findings.

Do not transfer the buffer or extracted sample from one kit into the other kit unless this procedure has been specifically validated.

Specimen Collection and Handling

Specimen type

Fresh human feces.

Collection instructions

• Collect approximately 1–2 g or 1–2 mL of feces in a clean and dry container.
• Avoid contamination with urine, toilet water, disinfectants or cleaning products.
• Unscrew the specimen collection tube.
• Insert the sampling applicator into at least five different areas of the stool specimen.
• Collect approximately 50 mg, roughly one-quarter of a pea-sized sample.
• Do not scoop a large amount of stool into the collection tube.
• Return the applicator to the tube and tighten the cap securely.
• Shake vigorously to mix the specimen with the extraction buffer.
• Allow the tube to stand for approximately two minutes before testing.

Specimen stability

For best performance:

• Test the specimen within six hours of collection.
• When immediate testing is not possible, specimens may be stored at 2–8°C for up to three days.
• For longer storage, keep specimens below −20°C, where permitted by the validated procedure.
• Bring refrigerated or frozen specimens to room temperature before testing.
• Frozen samples must be completely thawed and mixed thoroughly.
• Avoid repeated freezing and thawing.

The specimen-handling requirements of the final approved package insert should always take precedence.

Working Procedure

Before testing

Allow the following to reach 15–30°C:

• Test cassettes
• Specimen extraction tubes
• Patient specimens
• Controls, when used

Do not open the foil pouch until testing is ready to begin.

Test procedure

1. Check the product name, lot number and expiry date.
2. Remove the relevant test cassette from its sealed pouch.
3. Place the cassette on a clean, dry and level surface.
4. Mix the corresponding specimen collection tube thoroughly.
5. Hold the tube vertically.
6. Remove or break the dispensing tip as instructed.
7. Add three drops—approximately 100 µL into the specimen well marked S.
8. Start the timer.
9. Read the result at approximately five minutes.
10. Do not interpret the result after ten minutes.

Perform the hemoglobin and transferrin tests using their respective cassettes and specimen collection tubes.

Individual Result Interpretation

Positive

Two coloured lines appear:

• One line in the control region—C
• One line in the test region—T

Any visible test line should be considered positive, even when faint, provided that the control line is present and the result is read within the specified time.

Negative

One coloured line appears in the control region—C, with no coloured line in the test region—T.

A negative result means that the biomarker was not detected above the test threshold. It does not completely exclude intermittent bleeding, colorectal polyps, colorectal cancer or other gastrointestinal disease.

Invalid

The control line does not appear.

Possible causes include:

• Insufficient specimen volume
• Incorrect specimen application
• Improper procedural technique
• Damaged test device
• Deteriorated or expired product

Repeat the test using a new cassette. Do not report an invalid result.

Combined Result Interpretation

The two-test pattern must not be used to determine the exact anatomical source of bleeding.

Clinical Follow-Up

When either test is positive

A positive Hb or Tf result should be assessed together with:

• Patient age
• Gastrointestinal symptoms
• Family history
• Previous colorectal polyps
• Inflammatory bowel disease
• Medication history
• Physical examination
• Other laboratory and diagnostic findings

Depending on the patient’s risk profile, further evaluation may include:

• Physician assessment
• Complete blood count
• Iron studies
• Gastroenterology referral
• Colonoscopy
• Imaging or other investigations

A positive fecal blood-related test does not necessarily mean that the patient has cancer. However, positive colorectal screening results should not be ignored, and appropriate diagnostic follow-up should be arranged.

Storage and Stability

• Store each unopened test kit at 4–30°C.
• Keep the device in its original sealed pouch until use.
• Protect from direct sunlight, excessive heat and moisture.
• Do not freeze the test device unless specifically permitted by the manufacturer.
• Use the test before the expiry date printed on the package.
• After opening the foil pouch, use the cassette within one hour.
• Do not use the product when the pouch is damaged.
• Do not interchange devices, buffers or collection tubes between different products, lots or manufacturers.

Materials Provided

The contents may vary according to the registered product configuration.

Hemoglobin test package

• Fecal Hemoglobin Rapid Test Cassette
• Specimen collection tube with extraction buffer
• Package insert

Transferrin test package

• Fecal Transferrin Rapid Test Cassette
• Specimen collection tube with extraction buffer
• Package insert

Materials required but not provided

• Clean specimen collection container
• Timer
• Disposable gloves
• Protective clothing
• Biohazard disposal container
• Positive and negative controls, where required

Quality Control

Each cassette contains an internal procedural control.

A valid control line confirms:

• Proper specimen application
• Adequate liquid migration
• Functional test reagents
• Correct procedural performance

External positive and negative controls are not necessarily included. Their periodic use is recommended according to laboratory policy, regulatory requirements and good laboratory practice.

Do not report patient results when quality-control requirements are not met.

Warnings and Precautions

• For professional and in-vitro diagnostic use only.
• For single use only.
• Do not use after the expiry date.
• Do not use if the sealed pouch is damaged.
• Handle all fecal specimens as potentially infectious.
• Wear gloves, protective clothing and eye protection as appropriate.
• Do not eat, drink or smoke in the testing area.
• Avoid direct contact with specimen and extraction buffer.
• Dispose of used devices and specimens according to applicable biomedical-waste procedures.
• Do not reuse test cassettes, droppers or collection tubes.
• Do not mix reagents from different kits or lots.
• Follow institutional biosafety procedures.
• Keep away from children.

Limitations

• These are qualitative screening tests.
• They do not measure the exact concentration of hemoglobin or transferrin.
• A positive result indicates the presence of the relevant biomarker, not the cause of bleeding.
• Positive results can occur with non-cancerous conditions, including hemorrhoids, ulcers, inflammation, polyps and diverticular disease.
• Bleeding may be intermittent; therefore, a negative result does not completely exclude disease.
• Improper specimen collection, storage or testing may cause inaccurate results.
• Results should not be interpreted after the specified reading time.
• These tests do not replace colonoscopy or comprehensive clinical evaluation.
• High-risk or symptomatic patients may require direct diagnostic assessment regardless of a negative rapid-test result.
• No combined diagnostic sensitivity or specificity should be claimed unless the dual-testing algorithm has been independently validated.

Frequently Asked Questions

Are the two tests supplied in one box?

No. The Fecal Hemoglobin and Fecal Transferrin tests are supplied as two separately packaged products.

Can they be performed from the same stool specimen?

Yes. One stool specimen may be used, but it should be sampled separately into the collection tube supplied with each product.

Can the same extraction tube be used for both tests?

No, unless the specific product configuration has been validated for shared extraction. Each test should normally be performed using its own supplied collection system.

Does a positive result mean colorectal cancer?

No. A positive result indicates that a blood-related biomarker was detected in the fecal specimen. Further clinical assessment is required to determine the cause.

What happens when one test is positive and the other is negative?

This may occur because hemoglobin and transferrin have different biological and stability characteristics. Either positive result should be clinically evaluated.

Does a negative result exclude colorectal cancer?

No. Bleeding may be intermittent, below the detection threshold or absent at the time of collection.

Are dietary restrictions required?

These antibody-based tests detect human blood proteins and generally do not require the dietary restrictions associated with traditional guaiac-based occult blood tests. Patients should nevertheless follow the final approved product instructions.