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Faecal Occult Blood Test
Faecal Occult Blood Test

Faecal Occult Blood Test

The SAFECARE FOB Rapid Test Device is a rapid immunochromatographic assay designed for the qualitative detection of human hemoglobin in fecal specimens. It serves as an auxiliary diagnostic tool for lower gastrointestinal bleeding conditions, including colorectal concerns. The test provides results within minutes and is intended for professional in vitro diagnostic use only.
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Product Overview
FOB01

The SAFECARE FOB Rapid Test Device is a rapid immunochromatographic assay designed for the qualitative detection of human hemoglobin in fecal specimens. It serves as an auxiliary diagnostic tool for lower gastrointestinal bleeding conditions, including colorectal concerns. The test provides results within minutes and is intended for professional in vitro diagnostic use only.

 

Disease Background

 

 

Fecal occult blood (FOB) , often undetectable visually, can be an early sign of serious lower gastrointestinal (GI) conditions, most notably colorectal cancer – a leading cause of cancer-related deaths worldwide. Early detection of colorectal bleeding significantly improves treatment outcomes. Other potential causes include polyps, diverticulitis, colitis, hemorrhoids, ulcers, and GI irritations. Regular screening for fecal occult blood is a crucial non-invasive step in identifying individuals requiring further diagnostic investigation (like colonoscopy).

 

Ordering Information

 

 

Product Name

Catalog No.

Specimen

Format

Certification

Fecal Occult Blood Rapid Test Device

FOB-5011

Feces

Strip

CE
 

FOB-5012

Feces

Cassette

CE

 

 

Product Advantages

 
1

High Accuracy: Demonstrates 94.5% sensitivity and 99.8% accuracy compared to leading rapid tests.

2

Ease of Use: Simple procedure with clear visual results.

3

No Dietary Restrictions: Patients do not need to modify their diet before sample collection.

4

Rapid Results: Results available in 5 minutes.

5

CE Marked: Complies with European regulatory standards for in vitro diagnostic devices.

6

Stable Storage: Long shelf life when stored between 2–30°C in a sealed pouch.

FOB02

 

Operation Steps

 

FOB03

FOB04

 

FAQ

 

 

Q: How long does the test take?​​

A: The result can be read at 5 minutes.

Q: Are there any dietary restrictions before taking the test?​​

A: No, the product insert states that no dietary restrictions are necessary before testing.

Q: What can cause a false positive result?​​

A:Bleeding from non-cancerous sources like hemorrhoids, blood in urine, or stomach irritation can cause a positive result. Always consult a physician for a confirmed diagnosis.

Q: What if the control line does not appear?​

A: This is an invalid result. The test should be discarded and repeated with a new device. This is typically caused by incorrect procedure, insufficient sample volume, or using an expired test.

Q: Can this test detect all colorectal cancers?​

A: No. Some cancers or polyps may bleed intermittently or not at all, leading to a negative result. A negative result does not completely rule out disease. It is a screening tool, not a definitive diagnosis.

Q: Who should use this test?​

A: This is a professional-use IVD device intended for use by healthcare professionals in a clinical setting.

 

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