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Product Name: CEA Rapid Diagnostic Test

Intended Use:

The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of CEA in whole blood, serum or plasma to aid in monitoring of cancer patients.

Test Principle:

The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane based immunoassay for the detection of CEA in whole blood, serum or plasma. The membrane is pre-coated with anti-CEA antibodies on the test line region. During testing, the specimen reacts with the particle coated with anti-CEA antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-CEA antibodies on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

PERFORMANCE CHARACTERS:

Sensitivity and Specificity

The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) has correctly identified a panel of specimens and has been compared to a leading commercial CEA EIA test using clinical specimens. The results show that the relative sensitivity of the CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) is 98.9%, and the relative specificity is 99.5%.

Relative Sensitivity: 98.9% (95%CI*: 96.2%-99.9%) * Confidence Interval

Relative Specificity: 99.5% (95%CI*: 98.2%-99.9%)

Accuracy: 99.3% (95%CI*: 98.3%-99.8%)

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.