IVD SYSTEMS & AUTOMATED CLINICAL DIAGNOSTIC ANALYSERS
banner12.jpg

EASY Line

New Line for Rapid Diagnostic Tests

Rapid Test Product Information & Purchase Order

Method & Sample Line Product Package Info
Tumour Markers EASY Line EASY Line Fecal Occult Blood (FOB) Test (Strip) Tests per Package: 50
Fecal Code: 15900-2 Package Format: Strip (3mm)
image not exist
  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

  • Stock:
  • Available
    *Usually shipping within 5 business days
  • Min Order:
  • 5 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

Please pay attention to the revision of the document that must be the same as the revision reported in the box label.
In case of discrepancy please contact our Customer Care e-mail: info@adaltis.net.

* Other document related to the product available at Documentation Centre and it is accessible for Adaltis distributors/partners after registration only.

The EASY Line Fecal Occult Blood (FOB) Test is a rapid one step screening test for the qualitative detection of FOB in stool sample. Test results are read visually without any instrument.

For “in vitro” diagnostic use only.

EASY Line Fecal Occult Blood (FOB) Test is a lateral flow chromatographic immunoassay for the qualitative detection of FOB in stool sample at the following cut-off concentrations:

Test

Calibrator

Cut-off

EASY Line Fecal Occult Blood (FOB) Test

Fecal Occult Blood (FOB)

200 ng/mL

Fecal occult blood test is an important means of diagnosis of gastrointestinal bleeding and gastrointestinal cancer screening simple and easy. Commonly used laboratory method for the o-toluidine method, which reagent stability is poor, their sensitivity, specificity and robustness are obvious deficiencies; present more and more laboratories using colloidal gold test strip assay, this method is superior in many aspects o-toluidine method, but also inadequate in some respects.

EASY Line Fecal Occult Blood (FOB) Test is a immunoassay utilizing highly specific reactions between double antibody sandwich for the detection of Fecal Occult Blood.

EASY Line Fecal Occult Blood (FOB) Test is a rapid stool samples screening test that utilizes monoclonal antibodies to selectively detect elevated levels of Fecal Occult Blood without the of an instrument.

Fecal occult blood (feces occult blood): also known as fecal occult blood refers gastrointestinal bleeding, destruction of red blood cells to be digested, no abnormal change in stool appearance under the microscope to the naked eye and cannot confirm the bleeding.

Bloody stool situation caused by gastrointestinal bleeding, usually including fecal occult blood and blood in the stool. Fecal occult blood and stool although only one word, but both very different performance for the diagnosis of the disease is also great differences.

Blood in the stool: the colour was bright red, dark red or tarry, more performance for blood stools, tarry stools, common in the lower digestive tract especially the colon, rectum and anal bleeding a particular symptom, suggesting intestinal organic disease. Generally can be directly judged by the naked eye, and therefore beneficial when patients find themselves taking aggressive diagnosis and treatment.

Fecal occult blood: a small amount of gastrointestinal bleeding, stool does not cause colour change, the destruction of red blood cells to be digested, no abnormal change in stool appearance under the microscope cannot confirm the naked eye and bleeding, stool tests only when they found a small amount of blood cells, because long-term bleeding, often accompanied by symptoms of anemia. Because fecal occult blood cannot be found directly by the naked eye, resulting in the vast majority of early gastrointestinal cancer patients are unable to timely detection and early intervention, thus delaying the optimal timing of treatment, as is generally hidden killer lurking in our body.

EASY Line Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and qualitative detection of human occult blood in feces. The assay is designed to detect lower levels of colorectal bleeding than other biochemical detection methods. The test principle is an immunochromatographic sandwich method, which employ two specific monoclonal antibodies to selectively identify hemoglobin in test samples. The result is very specific, and easier to interpret than those of guaiac-basic test. The sensitivity is very high with the ability to detect 200 ng/mL hemoglobin in feces. In addition, the accuracy of the test is not affected by interfering substances, and dietary restriction is not necessary.

The kit contains reagents for 50 tests in strip (code 15900-2).

Individually packed test devices (strip)

50

Sample Collection Tube

50

Number of tests

50

Code

15900-2

The test contains a membrane strip coated with Hemoglobin antibody conjugates on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with Hemoglobin antibody.

  • Specimen collection container (for strip, cassette)

  • Disposable gloves

  • Timer

Accuracy

A side-by-side comparison was conducted using EASY Line Fecal Occult Blood (FOB) Test and other commercially available rapid One Step Fecal Occult Blood Test. Testing was performed on 1200 stool samples. All the presumptive positive and negative results were confirmed by the result of hospital.

Test

Substance

EASY Line Fecal Occult Blood (FOB) Test

 Fecal Occult Blood

%Agreement with results of hospital

 

FOB

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

%Agreement with commercial kit

 

FOB

Positive Agreement

100%

Negative Agreement

100%

Total Results

100%

The 1200 clinical samples for rotavirus were run using each strip contained within EASY Line Fecal Occult Blood (FOB) Test by an untrained operator at a Professional Point of Care site. The untrained operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

Reproducibility

Reproducibility studies were carried out using commercially available standards. Each standard was diluted in normal, stool sample to give the appropriate concentration. Each specimen, at each concentration of analyte, was tested eight times daily, in duplicate, for five consecutive days. A total of 40 determinations were made at each concentration. The results are given below:

Sample

Total number of Determinations

Result

Precision

Buffer

40

40 negative

>99%

Human hemoglobin 200 ng/mL

40

40 positive

>99%

Human hemoglobin 500 ng/mL

40

40 positive

>99%

Sheep hemoglobin 0.5 mg/mL

40

40 negative

>99%

Chicken hemoglobin 0.5 mg/mL

40

40 negative

>99%

Bovine hemoglobin 0.5 mg/mL

40

40 negative

>99%

Pig Hemoglobin 0.5 mg/mL

40

40 negative

>99%

Rabbit hemoglobin 0.5 mg/mL

40

40 negative

>99%

Dog hemoglobin 0.5 mg/mL

40

40 negative

>99%

Horseradishperoxidase2.0 mg/mL

40

40 negative

>99%

Analytical Sensitivity

Human hemoglobin was diluted with Normal saline Standard.The results are summarized below.

Antigen concentration Cut-off Range

ROV

-

+

Buffer

10

0

Human hemoglobin 100 ng/mL

10

0

Human hemoglobin 200 ng/mL

0

10

Human hemoglobin 500 ng/mL

0

10

Analytical Specificity

When the sample concentration is below the level of the material shown in the following list, and does not affect the test results.

Name

Concentration

Sheep hemoglobin

0.5 mg/mL

Chicken hemoglobin

0.5 mg/mL

Bovine hemoglobin

0.5 mg/mL

Pig Hemoglobin

0.5 mg/mL

Rabbit hemoglobin

0.5 mg/mL

Dog hemoglobin

0.5 mg/mL

Horseradish peroxidase

2.0 mg/mL

Cross-Reactivity

A study was conducted to determine the cross-reactivity test, whenother bacteria present in stool specimens.

Non Cross-Reacting Compound

When the sample concentration is below the level of the 107 bacteria/mL, and does not affect the test results.

Name

Name

Staphylococcus aureus

Neisseria gonorrhoeae

Pseudomonas aeruginosa

B streptococcus

Streptococcus C

Proteus vulgaris

Mucositis Brenham cocci

Feces Enterococcus

White rosary

Proteus variation

Neisseria meningitidis

Acinetobacter

Chlamydia trachomatis

Salmonella

Calcium acetate Acinetobacter

Vaginalis

E. coli

Klebsiella pneumoniae

Catarrhal Brenham bacteria

Haemophilus influenzae

Feces Enterococcus

Salmonella choleraesuis

Adenovirus

Rotavirus

The results show that those bacterias in Stool specimens above are all negative.

Need assistance to make an order? Contact Sales & Orders Centre order@adaltis.net.
For Application Support application@adaltis.net