Tumor Marker PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Strip Device Rapid Test Diagnostic Kit Accurate
Product name: PSA Prostate Specific Antigen Semi-quantitative Rapid Test Kit
Specimen: Whole blood/serum/plasma
Format: Strip/cassette
Specification: 25pcs, 40pcs, or customized
MOQ: 10,000 pcs
Sensitivity: 4ng/mL, 10ng/mL
Application: Specific antigen in prostate, help in diagnosis of early prostatic diseases.
CTnI One Step Troponin I Rapid Test Kit
(Whole blood/serum/plasma)
1.Product description
Introduction:
Product name:
CTnI One Step Troponin I Rapid Test Kit
Specification:
Lateral-flow Immunofluorescence Chromatographic Assay 10 pcs, 25 pcs, 50 pcs, 100 pcs/box, or customized
Type:
Cassette
MOQ:
10,000 PCS
Analytical Range:
1.0~50ng/ml (Whole Blood); 0.1~50ng/ml (Serum/Plasma)
Specimen:
Human serum/plasma/whole blood
Manufacturer:
Hangzhou Laihe Biotech Co., Ltd.
Clinical significance
1. Diagnosis of various chest pain
2. Foundation of ACS diagnosis and risk stratification
3. Best markers for ACS prognosis
4. An aid in the diagnosis of myocardial infarction (injury)
5. Can improve clinical, economic and operational outcomes
Principle
Insert the sample cassette into Immunofluorescence Quantitative Analyzer. The detection system will scan the markers and bond zone to gain optical signals, and then analyze the signals to get the concentration of the tested sample.
Storage
Valid for 24 months under 4-30 °C with aluminum foil bag packing. Once opened, the cassette is valid for 1 hour.
2.Application
Clinical Laboratory, ED, ICU, CCU, Respiratory Department, Cardiology Department, Pediatrics Department, Surgery Department, Hematology Department, etc.
A rapid, one step test for the qualitative detection of Amphetamines in human urine.
For healthcare professionals including professionals at point of care sites
For professional in vitro diagnostic use only.
A drug-free urine pool was spiked with Amphetamine at the following concentrations: 0 ng/mL, 500 ng/mL, 750 ng/mL, 1,000 ng/mL, 1,250 ng/mL and 1,500 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:
AMP Concentration (ng/mL)Percent of CutoffnVisual Result
NegativePositive
00%30300
500-50%30300
750-25%30237
1,000Cutoff30921
1,250+25%30129
1,500+50%30030
Multi-drug one step 2-15 drug test device
(urine/saliva)
1.Product description
15.Png
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Give a rapid diagnosis for reference to help in hospitals & clinics, rehabilitation centers, diseases control & prevention centers, military recruiting, high-risk group census, physical examination and some related special industries.
Urine or saliva specimen to choose, easy specimen collection
Instant result in 5 minutes
Ce marked
Valid for 24 months. Store at 2-30,
2.Features
-choices: urine or saliva specimen for multi-drug test
-test more than 2 drugs in one time, distinct c/t lines
-customized sensitivity, printing color and packing
-accurate, specific, quiet, stable, convenient
-latest production
-best seller in china domestic market, competitive quality and price
-easy payment and shipment
(Note: The cut-off value 2.0ng/ml is for reference only. Clinical departments shall adjust according to patient's situation.)
CRP/hsCRP
- Differential diagnosis of virus infection and bacterial infection
- CRP relating with cardiovascular disease (CVD)
- Accurate early diagnosis in pregnant women with amniorrhexis premature delivery and ch
hsCRP
< 1.0 mg/L
Cardiovascular disease risk: Low risk
1.0-3.0 mg/L
Cardiovascular disease risk: Moderate risk
Anti-inflammatory therapy is recommended.
> 3.0 mg/L
Cardiovascular disease risk: High risk
Anti-inflammatory and antithrombotic therapy is recommended.
CRP
< 10 mg/L
Less possibility of bacterial infection or bacterium are eradicated
10-25 mg/L
Virus infection signal
When course is short, bacterial infection is possible. Re-check after hours.
25-50 mg/L
Virus/bacterial infection signal
50-100 mg/L
Usually bacterial infection
Virus infection is uncommon.
> 100 mg/L
Bacterial infection signal
Less possibility of virus infection
We can provide various infectious diseases test kits as listed.
Product name
Cat. No.
Specimen
Packing
Chlamydia Rapid Test Device
ICH-502
Swab/urine
Cassette: 10 or 40pcs/box or Customized
HBsAg One Step Hepatitis B Surface Antigen Test Device
IHBsg-302
Serum/plasma
Cassette: 10 or 40pcs/box or Customized
HBsAg Hepatitis B Surface Antigen Rapid Test Device
IHBsg-402
Whole blood/serum/plasma
Cassette: 10 or 40pcs/box or Customized
HBsAg One Step Ultra Hepatitis B Surface Antigen Test Device
IHBsg-302U
Serum/plasma
Cassette: 10 or 40pcs/box or Customized
HCV Hepatitis C Virus Rapid Test Device
IHC-302
Serum/plasma
Cassette: 10 or 40pcs/box or Customized
HCV Hepatitis C Virus Rapid Test Device
IHC-402
Whole blood/serum/plasma
Cassette: 10 or 40pcs/box or Customized
HIV 1/2 Antibody Rapid Test Device
IHI-402
Whole blood/serum/plasma
Cassette: 10 or 40pcs/box or Customized
H. Pylori Antigen Rapid Test Device
IHPg-602
Feces
Cassette: 10 or 40pcs/box or Customized
H. Pylori Antibody Rapid Test Device
IHPb-602
Serum/plasma
Cassette: 10 or 40pcs/box or Customized
Syphilis Ultra Rapid Test Device
ISY-402U
Whole blood/serum/plasma
Cassette: 10 or 40pcs/box or Customized
Dengue Fever Rapid Test Device
IDE-402
Whole blood/serum/plasma
Cassette: 10 or 40pcs/box or Customized
Malaria P. f. /P. v. Rapid Test Device
IMA-422
Whole blood
Cassette: 10 or 40pcs/box or Customized
2.Features
-Customized sensitivity, printing color and packing
-Accurate, quiet, stable, convenient
-Latest production
-Competitive quality and price
-Easy payment and shipment
(1)The One Step Drug Screen Test Panel (Urine) is an immunoassay based on the principle of competitive binding.Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody.
(2)During testing,a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody coated on the particles. The antibody coated particles will then be captured by the immobilized drug conjugate and a visible colored line will show up in the test line region of the specific drug strip. The colored line will not form in the test line region if the drug level is above its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles.
A rapid test for the qualitative detection of antibodies (IgG and IgM) to Dengue virus in whole blood, serum, or plasma.
For professional in vitro diagnostic use only.
INTENDED USE
The Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.
DIRECTIONS FOR USE
Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.
1.Bring the pouch to room temperature before opening. 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 or Plasma Specimens:
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 μL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 L) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 uL) and start the timer. See illustration below.
To use a micropipette: Pipet and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below.
3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
A rapid test for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.
For professional in vitro diagnostic use only.
Sensitivity
The Malaria P.f/ Pan Rapid Test Device (Whole Blood) has been tested with thin or thick microscopy on clinical samples. The results show that the sensitivity of the Malaria P.f/ Pan Rapid Test Device (Whole Blood) is >99.9% relative to microscopy.
For Pan:
Relative Sensitivity: >99.9% (158/158) (97.6%100.0%)*
For P.f:
Relative Sensitivity: >99.9% (53/53) (93%100.0%)*
Specificity
The Malaria P.f/ Pan Rapid Test Device (Whole Blood) uses highly specific antibodies for Malaria P.f/ Pan antigens in whole blood. The results show that the specificity of the Malaria P.f/ Pan. Rapid Test Device (Whole Blood) is over 99.0% relative to microscopy.
Relative Specificity: >99.0% (324/327)(97.3%99.8%)*
Accuracy: >99.4%(535/538)(98.3%99.8%)*
* 95% Confidence Interval
Total Results211327538
Note: The comparison for Pan line has been only done with blood specimens positive with Plasmodium vivax specimen. The claims for Pan lines are based on scientific findings that Pan-malarial Aldolase is found in other malarial parasites including Plasmodium ovale and Plasmodium malariae.