Tumor marker Prostate specific antigen PSA Quantitative rapid test kit

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Product Overview

Description



Product Description




Product Information



Product Name
Tumor Marker PSA Prostate specific antigen Rapid Test Kit
Format
Cassette
Test Item
Prostate specific antigen
Specimen
Whole blood/Serum/Plasma
Storage
2-30°C
Specification
25 pcs/box
Matched Machine


Materials Provided

A Box:
(1)The test device consists of test strip and a plastic device. The main components in the test strip are nitrocellulose membrane, absorbent paper, PVC board. The membrane is pre-coated with anti-PSA antibodies on the test line region.
(2)ID chip:It contains information including product name, product lot number and standard curve.
Specification: 1pcs/box
B Box:
(1)Sample buffer:it consists of fluorescent indicators of Prostate specific antigen monoclonal antibodies, rabbit IgG fluorescent indicators and PBS.
Specification: 25 tubes/box
Explanation:Different batches of test kits are not interchangeable in order to avoid the wrong results.
Materials required but not provided: pipette and dropper for sample adding







Direction and Result


Please read the instruction of diagnostic kit and immunofluorescence quantitative analyzer manufactured by Hangzhou Laihe Biotech Co., Ltd. carefully before using the device.

1. Preparation:Switch on immunofluorescence quantitative analyzer manufactured by Hangzhou Laihe Biotech Co., Ltd. 


2. The test card, ID chip, buffer and test sample shall be cooled down to room temperature before testing(15-30℃). Opening the test kit after it reaches to room temperature is suggested.


3. Ensure ID card and test kit are the same lot number and then insert ID chip into port. Press “read ID chip” button after entering the test interface. With calibration completed, test kit can be detected.


4. Sample adding:Add 40μl samples to the detection buffer tube If the sample type is serum or plasma. Add 80μl samples if the sample type is whole blood. Fully mix (30s-1min) and absorb 75μl mixture into the reagent plate.


5. Mode choose:According to sample mode, choose the plasma/ serum mode or whole blood mode in the sample type options on immunofluorescence analyzer.


6. Analyzing:
①Normal Analyze:insert the test device into analyzer immediately after sample adding and then press “Analyze” button. Analyzer will have an automatic count-down by system and automatically read test kit and provide test results.
②Immediate Analyze:wait for 12 minutes after sample adding, then insert the test device into analyzer, press “test” button. Analyzer will automatically read test kit and provide test results.

 

7. Press “Print” button and the test results will be automatically printed in paper document. 


8. Make inactivation treatment of test device after testing, rest buffer, pipette head and rest clinical specimens.




Interpretation of Results

If PSA<4.0ng/mL, it indicates no risk of prostate cancer

If PSA>4.0ng/mL, it indicates a possible risk of prostate cancer



Packing






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About Company




Company Instruction

Hangzhou Laihe Biotech Co., Ltd. (hereafter referred to as "Laihe Biotech") is a life science company specialized in R & D, manufacturing, marketing and service in point-of-care testing, monitoring and health technology industry, is committed to provide fast, accurate and reliable health detection products and services. Founded by Dr returned from United States in February 2012, today Laihe Biotech has a team of experienced scientists researching and developing diagnostic products.
At present, we have a wide range of products including Drug of abuse test kit, Cardiac marker test kit, Tumor marker test kit, Fertility test kit, Infectious diseases test kit, Torch test kit, POCT test kit, POCT Quantitative Immunofluorescence Analyzer, Hair Drug Trace Rapid Analyzer.        



History

Hangzhou Laihe Biotech Co., Ltd. (hereafter referred to as "Laihe Biotech") is a life science company specialized in R & D, manufacturing, marketing and service in point-of-care testing, monitoring and health technology industry, is committed to provide fast, accurate and reliable health detection products and services.



Professional Team

Founded by Dr returned from United States in February 2012, today Laihe Biotech have a team of experienced scientists researching and developing diagnostic products, and have already built an independent POCT platform which including various rapid test products like Cardiac Marker Series (cTnI, NT-proBNP, H-FABP, etc.), Inflammation Series (ds-CRP, PCT, etc.), Tumor Marker Series (AFP, CEA, etc.), Diabetes Monitoring Series (HbA1c), Fertility Series (TORCH) and Infectious Diseases Series. We continue to be innovative, and promote in-vitro diagnostic products in a miniaturized, individualized, family-oriented and low-cost way.







Certifications




Business license, production licence, ISO 13485, CE, FSC etc.



Our Service




Warehouse and Shipment

We have warehouse in our factory.

1. International express: TNT, DHL, FedEx, UPS, EMS. (door to door)

2. Logistics company: transportation by land, by air and by sea (according to customer's request)




After-sale Service System

Marketing research& customers feedback help us to know customers' further need and to upgrade our products. Our R&D direction keep pace with the marketing need: OEM support include sensitive adjustment (DOA); customer made packing and so on. New product lines are always being developed.
Professional and patient technical support are our service standard, If you have any technical problems, please contact us by Hotline/ Email/Facebook , we will reply you within 12 hours (working days).





Q&A


1. Are you manufacturer or trader ?

We're manufacturer and have our own factory, so our price is very competitive.



2. What product are you offering ?

With a wide range of tests, the eight most common tests are:
(1) Drug of abuse test kit
(2) Cardiac marker test kit
(3) Tumor marker test kit
(4) Fertility test kit
(5) Infectious diseases test kit
(6) TORCH test kit
(7) POCT test kit
(8) POCT Quantitative Immunofluorescence Analyzer
(9) POCT immunofluorescence analyzer



3. Can you offer samples and make customized products ?

Of course. For samples, lease pick up the models you like and inform us to do a PI for sample freight; we can customize the products as customer's request, such as cut-off (DOA), strip size, package, etc.



4. Where is your market ?

We got ISO 13485:9001 and CE certificate. Our main sales market is Asia, Europe, Africa, Middle East and Oceania.



5. What's the lead time after we confirm the order ?

Well, they depends on the quantity and package design of your order. Neutral packages are usually very fast, around 10-15 working days, while OEM packages usually takes 25-40 working days. Orders above 1,000,000pcs will need 2 months for first order.





4.9824 s.