PSA Rapid Test Cassette (Whole Blood/Serum/Plasma) (Semi-quantitative)

Name: PSA Rapid Test Cassette (Whole Blood/Serum/Plasma) (Semi-quantitative)
SKU: DTS218
Rating: 5 (1 reviews)

Regulatory status: For research use only, not for use in diagnostic procedures.

COA

SDS

Datasheet

Summary

Sample

Human whole blood, serum or plasma

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.

Storage

Store as packaged at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

Precision

Intra-Assay
Assays were carried out to determine assay reproducibility using replicates of 10 tests in three different runs for each of three lots using PSA specimen levels at 0ng/ml, 2ng/ml, 3ng/ml, 10ng/ml and 20ng/ml. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by using the five PSA specimen levels at 0ng/ml, 2 ng/ml, 3 ng/ml, 10 ng/ml and 20 ng/ml of PSA in 3 independent assays. Three different lots of the PSA Rapid Test Cassette (Whole Blood /Serum /Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Sensitivity

Sensitivity and Specificity
The PSA Rapid Test Cassette (Whole blood /Serum /Plasma) has been tested with a leading commercial PSA ELISA Test using clinical samples.

General Description

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.
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).
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.
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).
The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Cassette (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.

Citations

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Documents

pdf COA

pdf SDS

pdf Datasheet

QA & Reviews

Customer Reviews

References

External validation of the Briganti nomogram predicting lymph node invasion in patients with intermediate and high-risk prostate cancer diagnosed with magnetic resonance imaging-targeted and systematic biopsies: A European multicenter study

UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Authors: Diamand, Romain; Oderda, Marco; Albisinni, Simone; Fourcade, Alexandre; Fournier, Georges; Benamran, Daniel; Iselin, Christophe; Fiard, Gaelle; Descotes, Jean-Luc; Assenmacher, Gregoire; Svistakov, Ilyas; Peltier, Alexandre; Simone, Giuseppe; Di Cosmo, Giacomo; Roche, Jean-Baptiste; Bonnal, Jean-Louis; Van Damme, Julien; Rossi, Maxime; Mandron, Eric; Gontero, Paolo; Roumeguere, Thierry

Abstract

Objective: To validate a nomogram predicting lymph node invasion (LNI) in prostate cancer patients undergoing radical prostatectomy taking into consideration multiparametric-magnetic resonance imaging (mp-MRI) parameters and targeted biopsies in a western European cohort. Patients and Methods: A total of 473 men diagnosed by targeted biopsies, using software-based MRI-ultrasound image fusion system, and operated by radical prostatectomy with extended pelvic lymph node dissection across 11 Europeans centers between 2012 and 2019 were identified. Area under the curve of the receiver operator characteristic curve, calibration plot and decision curve analysis were used to evaluated the performance of the model. Results: Overall, 56 (11.8%) patients had LNI on final pathologic examination with a median (IQR) of 13 (9-18) resected nodes. Significant differences (all P < 0.05) were found between patients with and without LNI in terms of preoperative PSA, clinical stage at DRE and mp-MRI, maximum diameter of the index lesion, PI-RADS score, Grade Group on systematic and targeted biopsies, total number of dissected lymph nodes, final pathologic staging and Grade Group. External validation of the prediction model showed a good accuracy with an area under the curve calculated as 0.8 (CI 95% 0.75-0.86). Graphic analysis of calibration plot and decision curve analysis showed a slight underestimation for predictive probability for LNI between 3% and 22% and a high net benefit. A cut-off at 7% was associated with a risk of missing LNI in 2.6%, avoiding unnecessary surgeries in 55.9%. Conclusions: We report an external validation of the nomogram predicting LNI in patients treated with extended pelvic lymph node dissection in a western European cohort and a cut-off at 7% seems appropriate. (C) 2020 Elsevier Inc. All rights reserved.

Ecological risks of demersal fishing on deepwater chondrichthyan populations in the Southern Indian and South Pacific Oceans

ICES JOURNAL OF MARINE SCIENCE

Authors: Georgeson, L.; Rigby, C. L.; Emery, T. J.; Fuller, M.; Hartog, J.; Williams, A. J.; Hobday, A. J.; Duffy, C. A. J.; Simpfendorfer, C. A.; Okuda, T.; Stobutzki, I. C.; Nicol, S. J.

Abstract

Risks to deepwater chondrichthyans (sharks, rays, and chimaeras) from fishing are poorly understood, particularly in areas beyond national jurisdiction. We adapted productivity-susceptibility analysis (PSA) and sustainability assessment for fishing effects (SAFE) to assess the vulnerability of 173 deepwater chondrichthyans to various demersal fishing gears in the Southern Indian and South Pacific Oceans. Several species were categorized as being at high or extreme vulnerability, including some deepwater shark species in the Southern Indian Ocean that are reported to be commercially targeted. There was good concurrence between PSA and SAFE results for species categorized as being at high or extreme vulnerability by the SAFE, but as expected there was an overall greater number assessed to be as higher vulnerability using PSA due to its precautionary nature. Our results indicate probable misclassifications in the PSA relative vulnerability rankings, highlighting the value of applying more quantitative tools, such as SAFE, when adequate data are available. Our findings indicate that better catch, effort, and biological information are needed to inform the assessment and management of deepwater chondrichthyans. If targeted fishing of deepwater shark species continues in the Southern Indian Ocean, improved assessments and estimates of sustainable yields are urgently required to mitigate the risk of overexploitation.