Tumor Mark PSA Home Testing Kits Semi - Quantitative Detection For Prostate Antigen

Tumor Mark PSA Home Testing kits, detecting Prostate specific antigen, High Accuracy, private test use

Product Name: Tumor Mark PSA Home Testing kit

Intended Use:

The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Cassette (Whole Blood

/Serum /Plasma) is a rapid chromatographic immunoassay for semi-quantitative detection of Prostate Specific Antigen in whole blood, serum or plasma.

Summary:

Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It is a single chain glycoprotein with a molecular weight of approximate 34 kDa.1 PSA exists in three major forms circulating in the serum. These forms are free PSA, PSA bound to α1 – Antichymotrypsin (PSA-ACT) and PSA complexed with α2–macroglobulin (PSA-MG).2 PSA has been detected in various tissues of the male urogenital system but only prostate glandular and endothelial cells secrete it. The PSA level in serum of healthy men is between 0.1 ng/mL and 2.6 ng/mL. It can be elevated in malignant conditions such as prostate cancer, and in benign condition such as benign prostatic hyperplasia and prostatitis. A PSA level of 3 to 10ng/ml is considered to be in the “gray-zone” and levels above 10ng/ml are highly indicative of cancer.3 Patients with PSA values between 3-10ng/ml should undergo further analysis of the prostate by biopsy. The prostate specific antigen test is the most valuable tool available for the diagnosis of early prostate cancer. Many studies have confirmed that the presence of PSA is the most useful and meaningful tumor marker known for prostate cancer and prostate infection of Benign Prostatic Hyperplasia (BPH).4 The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Device (Whole blood /Serum /Plasma) utilizes a combination of colloidal gold conjugate and anti-PSA antibodies to selectively detect total PSA in whole blood, serum or plasma. The test has a cut-off value of 3ng/ml and a reference value of 10ng/ml.

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

Clinical Performance For One Step PSA Test

A total of 257 patients was selected as participants in this study, the samples collected from these patients were tested by the RDTs and by a commercial Elisa Test. Comparison for all subjects is showed in the following table.

Table 2　

Sensitivity＝[106/(106+5)]×100%=95.50%

Specialty＝[143/(3+143) ]×100%=97.95%

Total＝[(106+143)/(106+5+3+143)]×100%=96.89%

Conclusion

257 samples were tested by RDT test and Elisa test for PSA.When compared with the reference standard, PSA RDT has a sensitivity and specificity of 95.50% and 97.75% respectively.

There are many ways to detect PSA in Serum. The ELISA is the most sensitive assay and is particularily effective when a large number of samples are processed per day. However, for laboratories with small caseloads, the time and labor to carry out ELISAs can be demanding. The one step PSA tests (Deangel) are easier to employ and provide results in a more rapid fashion compared with the traditional PSA detection methods currently used in forensic science. Since PSA RDT tests offer the same sensitivity as ELISA, they present a viable alternative for many laboratories.