Hot Selling Psa Prostate Specific Antigen Test Cassette

Product Description

Hot Selling PSA Prostate Specific Antigen Test Cassette
 
A rapid test for the semi-quantitative detection of prostate specific antigen (PSA) in whole blood,
serum or plasma.
For professional in vitro diagnostic use only.
 
 
 1) INTENDED USE
 
Hot Selling PSA Prostate Specific Antigen Test Cassette is
a rapid chromatographic immunoassay for semi-quantitative detection of Prostate Specific Antigen in
whole blood, serum or plasma.
 
2) SUMMARY
 
Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It is a single
chain glycoprotein with a molecular weight of approximately 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 4 to 10 ng/mL is considered to be
in the "gray-zone" and levels above 10 ng/mL are highly indicative of cancer.3 Patients with PSA
values between 4-10 ng/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 4 ng/mL and a reference value of 10 ng/mL.
 
3) PRINCIPLE 
 
Prostate Specific Antigen Rapid Test Device PSA Detection in Whole Blood/Serum/Plasmais
a semi-quantitative, membrane based immunoassay for the detection of PSA in whole blood, serum or
plasma. The membrane is pre-coated with PSA antibodies on the test line region. During testing, the
specimen reacts with the particle coated with anti-PSA antibody. The mixture migrates upward on the
membrane chromatographically by capillary action to react with anti-PSA antibodies on the membrane
and generate a colored line. A test line (T) intensity weaker than the reference line (R) indicates that
the PSA level in the specimen is between 4-10 ng/mL. A test line (T) intensity equal or close to the
reference line (R) indicates that the PSA level in the specimen is approximately 10 ng/mL. A test line
(T) intensity stronger than the reference line (R) indicates that the PSA level in the specimen is above
10 ng/mL. To serve as a procedural control, a colored line will always appear in the control line region
(C) indicating that proper volume of specimen has been added and membrane wicking has occurred.
 
4) STORAGE AND STABILITY
 
Store as packaged in the sealed pouch either 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.
 
5) SPECIMENS COLLECTION AND PREPARATION
 
The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Device (Whole Blood/Serum/Plasma)
can be performed using whole blood (from venipuncture or fingerstick), serum, or plasma.

To collect Fingerstick Whole Blood specimens:

Wash the patient's hand with soap and warm water or clean with an alcohol swab. Allow to dry.

Massage the hand without touching the puncture site by rubbing down the hand towards the
fingertip of the middle or ring finger.

Puncture the skin with a sterile lancet. Wipe away the first sign of blood.

Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the
puncture site.

Add the Fingerstick Whole Blood specimen to the test by using a capillary tube:

Touch the end of the capillary tube to the blood until filled to approximately 80 μL. Avoid air
bubbles.

Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the
whole blood onto the specimen well (S) of the test device.

Add the Fingerstick Whole Blood specimen to the test by using hanging drops:

Position the patient's finger so that the drop of blood is just above the specimen well (S) of the
test device.

Allow 2 hanging drops of fingerstick whole blood to fall onto the specimen well (S) of the test
device, or move the patient's finger so that the hanging drop touches the specimen well (S).
Avoid touching the finger directly to the specimen well (S).

Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, nonhemolyzed
specimens.

Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
 
6) MATERIALS
 
A. Materials Provided
 
Test devices         Droppers            Buffer             Package insert
 
B. Materials Required But NOT Provided
 
Timer              Specimen collection containers           Lancets (for fingerstick whole blood only)
Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
Centrifuge
 
7) DIRECTION FOR USE 
 
Allow the test, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C)
prior to testing.

1. Bring the pouch and buffer to room temperature before opening pouch. Remove the test device
from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface.

For Serum, Plasma or Venipuncture Whole Blood specimens:

Hold the dropper vertically and transfer 1 drop of serum, plasma (approximately 40 μL) or 2 drops of
venipuncture whole blood (approximately 80 μL) to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.

For Fingerstick Whole Blood specimens:

To use a capillary tube: Fill the capillary tube and transfer approximately 80 μL of fingerstick
whole blood specimen to the specimen well (S) of the test device, then add 1 drop of buffer
(approximately 40 μL) and start the timer. See illustration below.

To use hanging drop: Allow 2 hanging drops of fingerstick whole blood specimen
(approximately 80 μL) to fall into the center of the specimen well (S) of the test device, then add
1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear.* Read the result at 5 minutes. Do not interpret the result
after 10 minutes.

*Note: If migration is not observed in the result window after 30 seconds, add one or two extra
drops of buffer.
 
8) INTERPRETATION OF RESULTS
 
                                           (Please refer to the illustration above)

POSITIVE: Three distinct colored lines appear.

A. A test line (T) intensity weaker than the reference line (R) indicates a PSA level between 4-10 ng/mL.

B. A test line (T) intensity equal or close to the reference line (R) indicates a PSA level of
approximately 10 ng/mL.

C. A test line (T) intensity stronger than the reference line (R) indicates a PSA level above 10 ng/mL
.
NEGATIVE: Colored lines appear in both the control (C) and reference (R) regions. No
apparent colored line appears in the test line region (T). This indicates a PSA level below 4 ng/mL.
 
INVALID: Control line (C) or reference line (R) fail(s) to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for control line and reference 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.
 
 
9) QUALITY CONTROL 
 
A procedural control is included in the test. The appearance of colored lines in the control line
region (C) and reference line region (R) is considered a procedural controls. It confirms sufficient
specimen volume, adequate membrane wicking 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.
 
10) CLINICAL SENSITIVITY, SPECIFICITY AND ACCURACY
 
The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Device (Whole Blood/Serum/
Plasma) has been tested with a leading commercial PSA EIA Test using clinical samples.
 
Relative Sensitivity: 98.7% (95.4%-99.8%)*
Relative Specificity: 98.5% (96.3%-99.6%)*
Relative Accuracy: 98.6% (97.0%-99.5%)*
 
 
We are a supplier of rapid test kits products in China . Focus areas are one step Fertility Test Kits, One Step Drug of Abuse Test Kits , One Step Cardiac Marker Test Kits, One Step Infectious Disease Test Kits and One Step Tumor Marker Test Kits . Welcome to contact us  as following for our Newest Product Catalogue :
 
 
 
TEL: +86-571-87352763
 
FAX:+86-571-87352130
 
 
 
Other Products available in our factory :

Tumor Markers Rapid Test
Catalog No.	Product name	Specimen	Format	Sensitity	CE	SFDA
TFOB-16	FOB Fecal Occult Blood Test	Feces	Strip/Cassette	50/200ng/ml		√
TAFP-14	AFP Alpha-Fetoprotein Test	WB/S/P	Strip/Cassette
TCEA-14	CEA Carcinoembryonic Antigen Test	WB/S/P	Strip/Cassette
TPSA-14	PSA Prostate Specific Antigen Test	WB/S/P	Strip/Cassette
Cardiac Markers Rapid Test
Catalog No.	Product name	Specimen	Format	Sensitity	CE	SFDA
CTI-402	TnI One Step Troponin I Test	WB/S/P	Strip/Cassette	0.5ng/ml		√
CMA-435	Myoglobin/CK-MB/Troponin I Combo Test	WB/S/P	Strip/Cassette	see insert		√
Fertility Rapid Test
Catalog No.	Product name	Specimen	Format	Sensitity	CE0197	SFDA
FHCG-11	hCG Pregnancy Test	Urine	Strip/Cassette/Midstream	10/25mIU/ml	√	√
FHCG-12	hCG Pregnancy Test	Urine/Serum	Strip/Cassette/Midstream	25mIU/ml		√
FLH-11	LH Ovulation Test	Urine	Strip/Cassette/Midstream	20/25mIU/ml	√	√
FFSH-11	FSH Menopause Test	Urine	Strip/Cassette/Midstream	25mIU/ml

 
 

Infectious Disease Rapid Test
Catalog No.	Product name	Specimen	Format	CE	SFDA
IDEAB-13	Dengue IgG/IgM Test	Serum/Plasma	Cassette	√
IDEAG-14	Dengue NS1 Antigen Test	Whole Blood/Serum/Plasma	Strip/Cassette	√
IDEN-14	Dengue IgG/IgM/NS1 Antigen Test	Whole Blood/Serum/Plasma	Cassette	√
IHAV-14	HAV Hepatitis A Virus IgG/IgM Test	Whole Blood/Serum/Plasma	Cassette
IHBsg-14	HBsAg Hepatitis B Surface Antigen Test	Whole Blood/Serum/Plasma	Strip/Cassette		√
IHBsb-14	HBsAb Hepatitis B Surface Antibody Test	Whole Blood/Serum/Plasma	Strip/Cassette
IHCV-14	HCV Hepatitis C Virus Test	Whole Blood/Serum/Plasma	Strip/Cassette		√
IHIV-14	HIV 1/2  Test	Whole Blood/Serum/Plasma	Strip/Cassette
IHIV-M14	HIV 1/2 Tri-line  Test	Whole Blood/Serum/Plasma	Cassette
IHPab-14	H.Pylori Ab Test	Whole Blood/Serum/Plasma	Strip/Cassette	√	√
IHPag-14	H.Pylori Ag Test	Feces	Strip/Cassette	√	Pending
IROT-16	Rotavirus Test	Feces	Strip/Cassette
IADE-16	Adenovirus Test	Feces	Strip/Cassette
IRAV-16	Rotavirus/Adenovirus Combo Test	Feces	Cassette
IFLUA-18	Influenza A	Secretion	Strip/Cassette
IFLUB-18	Influenza B	Secretion	Strip/Cassette
ILEI-13	Leishmania IgG/IgM Test	Serum/Plasma	Cassette
ILEP-13	Leptospira IgG/IgM Test	Serum/Plasma	Cassette
IMA-Fg14	Malaria Ag p.f Test Cassette	Whole Blood	Strip/Cassette	√
IMA-Vg14	Malaria Ag p.v Test Cassette	Whole Blood	Strip/Cassette	√
IMA-Tg14	Malaria Ag P.f/P.v Tri-line Test Cassette	Whole Blood	Cassette	√
IMA-Tb14	Malaria Ab P.f/P.v Tri-line Test Cassette	Whole Blood	Cassette	√
IMA-P14	Malaria P.f./Pan Tri-line Test Cassette	Whole Blood	Cassette	√
ITB-14	TB Tuberculosis Test	Whole Blood/Serum/Plasma	Strip/Cassette
ITOX-14	Toxo IgG/IgM Test	Whole Blood/Serum/Plasma	Cassette
ITP-14	Syphilis Test	Whole Blood/Serum/Plasma	Strip/Cassette	√	√
ITY-14	Typhoid IgG/IgM Test Cassette	Whole Blood/Serum/Plasma	Cassette
ITOM-345	ToRCH Toxo/Rubella/CMV/HSV 1/2 IgM Antibodies Combo Test Device	Whole Blood/Serum/Plasma	Cassette
IMC-435	MCT HBsAg/HCV/HIV Multi Combo Test	Whole Blood/Serum/Plasma	Cassette
IBR-14	Brucellosis (Brucella) IgG/IgM Test	Whole Blood/Serum/Plasma	Cassette
ICHA-14	Chikungunya IgM Test	Whole Blood/Serum/Plasma	Strip/Cassette
ICPab-14	Chlamydia Pneumoniae Ab Test	Whole Blood/Serum/Plasma	Strip/Cassette		Pending
ICTag-18	Chlamydia Trachomatis Ag Test	Secretion	Strip/Cassette		Pending
IMPab-14	Mycoplasma Pneumoniae IgM Ab Test	Whole Blood/Serum/Plasma	Strip/Cassette		Pending
INGHag-18	Neisseria Gonorrhoeae Ag Test	Secretion	Strip/Cassette		Pending
ITSH-13	Neonatal TSH Test	Serum/Plasma	Strip/Cassette

Drug of Abuse Rapid Test
Catalog No.	Product name	Specimen	Format	Cut off	CE	SFDA
DMOP-11	MOP Morphine Test	Urine	Strip/Cassette/Dipcard	100/200/300ng/ml	√	√
DMET-11	MET Methamphetamine Test	Urine	Strip/Cassette/Dipcard	300/500/1000ng/ml	√	√
DTHC-11	THC Marijuana Test	Urine	Strip/Cassette/Dipcard	50ng/ml	√	√
DKET-11	KET Ketamine Test	Urine	Strip/Cassette/Dipcard	500/1000ng/ml	√	√
DMDMA-11	MDMA Ecstasy Test	Urine	Strip/Cassette/Dipcard	500ng/ml	√	√
DCOC-11	COC Cocaine Test	Urine	Strip/Cassette/Dipcard	100/300ng/ml	√	√
DAMP-11	AMP Amphetamine Test	Urine	Strip/Cassette/Dipcard	500/1000ng/ml	√	Pending
DBZO-11	BZO Benzodiazepines Test	Urine	Strip/Cassette/Dipcard	200/300ng/ml	√	Pending
DOA-21	MOP-MET 2 IN1 Test	Urine	Cassette/Dipcard	Same as single	√	√
DOA-31	MOP-MET-KET 3 IN 1 Test	Urine	Cassette/Dipcard	Same as single	√	√
DOA-51	MOP-MET-KET-THC-MDMA 5 IN 1 Test	Urine	Cassette/Dipcard/Cup	Same as single	√	√
DOA-27	MOP-MET 2 IN1 Test	Saliva	Cassette	15ng/ml;50ng/ml	√	Pending
DK2-11	K2 Synthetic Cannabis Test	Urine	Strip/Cassette/Dipcard	200ng/ml	√
DBAR-11	BAR Barbiturates Test	Urine	Strip/Cassette/Dipcard	300ng/ml	√
DBUP-11	BUP Buprenorphine Test	Urine	Strip/Cassette/Dipcard	10ng/ml	√
DCOT-11	COT Cotinine Test	Urine	Strip/Cassette/Dipcard	200ng/ml	√
DEDDP-11	EDDP Methadone MetaboliteTest	Urine	Strip/Cassette/Dipcard	100ng/ml	√
DFYL-11	FYL Fentanyl Test	Urine	Strip/Cassette/Dipcard	200ng/ml	√
DMTD-11	MTD Methadone Test	Urine	Strip/Cassette/Dipcard	300ng/ml	√
DMQL-11	MQL Methaqualone Test	Urine	Strip/Cassette/Dipcard	300ng/ml	√
DOPI-11	OPI Opiate Test	Urine	Strip/Cassette/Dipcard	2000ng/ml	√
DOXY-11	OXY Oxycodone Test	Urine	Strip/Cassette/Dipcard	100ng/ml	√
DPCP-11	PCP Phencyclidine Test	Urine	Strip/Cassette/Dipcard	25ng/ml	√
DPPX-11	PPX Proproxyphene Test	Urine	Strip/Cassette/Dipcard	300ng/ml	√
DTCA-11	TCA Tricyclic Antidepressants Test	Urine	Strip/Cassette/Dipcard	1000ng/ml	√
DTML-11	TML Tramadol Test	Urine	Strip/Cassette/Dipcard	200/300ng/ml	√
DAMP-17	AMP Amphetamine Test	Saliva	Cassette	50ng/ml	√
DCOT-11	COT Cotinine Test	Saliva	Cassette	50ng/ml	√
DKET-17	KET Ketamine Test	Saliva	Cassette	200ng/ml	√
DMOP-17	MOP Morphine Test	Saliva	Cassette	15ng/ml	√
DMET-17	MET Methamphetamine Test	Saliva	Cassette	50ng/ml	√
DOPI-17	OPI Opiate Test	Saliva	Cassette	40ng/ml	√
DOXY-17	OXY Oxycodone Test	Saliva	Cassette	50ng/ml	√
DPCP-17	PCP Phencyclidine Test	Saliva	Cassette	10ng/ml	√
DOA-SN1	Multi-Drug Single Line Panel	Urine	Cassette/Dipcard/Cup	Same as single	√
DOA-MN1	Multi-Drug Multi Line Cassette	Urine	Cassette/Cup	Same as single	√
DALK-17	Saliva Alcohol Test	Saliva	Strip	See insert
*Cutoff in blue is the SAMHSA standard.