High Accuracy Fecal Occult Blood Home Testing kits, 4mm cassette, Detection of Colorectal cancer at home

Product Name: One Step Fecal Occult Blood Fecal Occult Blood Home Testing kits

Summary:

Many diseases can cause hidden blood in the feces. This is also known as Fecal Occult Blood (FOB), Human Occult Blood, or Human Hemoglobin. In the early stages, gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms, only occult blood. Traditional guaiac-based methods lack sensitivity and specificity, and also have diet restrictions prior to testing.The FOB Rapid Test Cassette (Feces) is a rapid test to qualitatively detect low levels of Fecal Occult Blood. The test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at 50ng/ml or higher, or 6μg/g feces. In addition, unlike guaiac assays, the accuracy of the test is not affected by the diet of the patients.

INTENDED USE:The FOB Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Human Occult Blood in feces.

QUALITY CONTROL

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal valid procedural control. It confirms sufficient specimen volume and correct procedural technique.

Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

TEST PROCEDURE

1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch.
3. Specimen collection. Please see “SPECIMEN COLLECTION AND STORAGE”.
4. Shake the sample collection tube well.
5. Holding the sample collection tube upright, carefully break off the tip of collection tube.
6. Squeeze 3 drops of sample solution into the sample well “S” .
7. Read results between 5-10 minutes. Do not read results after 10 minutes.

Limitation

1. The FOB Rapid Test Cassette (Feces) is for in vitro diagnostic use only.
2. The FOB Rapid Test Cassette (Feces) will only indicate the presence of Fecal Occult Blood, the presence of blood in feces does not necessarily indicate colorectal bleeding.
3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
4. Other clinically available tests are required if questionable results are obtained.

PERFORMANCE CHARACTERS:

The FOB Rapid Test Dipstick (Feces) has been compared with another leading commercial rapid test using clinical specimens.

Relative sensitivity: 95.0% (95%CI*: 91.0%~97.6%);

Relative specificity: 99.5% (95%CI*: 98.7%~99.9%);

Accuracy: 98.6% (95%CI*: 97.4%~99.0%). *Confidence Intervals

Sensitivity

The FOB Rapid Test Dipstick (Feces) can detect levels of Fecal Occult Blood as low as 50 ng/mL or 6 μg/g feces.

Cross-reactivity

The FOB Rapid Test Cassette (Feces) is specific to human hemoglobin. Specimens containing the following substances were diluted in the extraction buffer to a concentration of 1.0 mg/ml, and tested on both positive and negative controls with no effect on test results: Bovine hemoglobin, Chicken hemoglobin, Pork hemoglobin, Goat hemoglobin, Horse hemoglobin, Rabbit hemoglobin and Turkey hemoglobin.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.