Place of Origin:
ISO 13485, CE
WWHS β-HCG Rapid Quantitative Test Kit For Fertility Detection
The β-hCG Rapid Quantitative Test along with WWHS Fluorescence Immunoassay Analyzer (FIA) is
intended for vitro quantitative determination of β-hCG in human whole blood, serum or plasma. This
test used as an aid in the early detection of pregnancy.
Diagnostic Kit for Neutrophil gelatinase-associtated lipocalin(Immunochromatographic assay)
The kit is used for quantitative determination of Neutrophil gelatinase-associtated lipocalin (NGAL) in human urine. Clinically, it is mainly used to assist in the diagnosis of renal function injury.
The kit is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of NGAL. The NGAL antigen in the sample was first bound with the conjugated compound of fluorescent labeled NGAL monoclonal antibody, then moved and combined with another NGAL monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
|Test cards||25||It is composed of fluorescent pad (coated with fluorescently-labeled NGAL monoclonal antibody), nitrocellulose membrane (coated with NGAL monoclonal antibody and Goat anti mouse IgG antibody), absorbent paper and backing.|
|Sample diluent||25 (0.3mL/ tube)||Phosphate buffer|
|ID card||1||With specific stand curve file|
The components in different batches of kits cannot be used interchangeably.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
The normal reference value is less than 132ng/mL in this assay. It is strongly recommended that each laboratory should determine its own normal and abnormal values.
【Interpretation of test results】
【Limitation of method】
4. When the concentration of NGAL in the sample is less than 2000ng/mL, there is no hook effect.
1. Limits of detection
No higher than 10.00 ng/mL.
The relative deviation from the target value is limited to ±15.0%.
The within and between assay coefficient of variations are within 15.0%.
4. Linearity range
Within the linear range (10.00~ 1500.00)ng/mL, the linear correlation coefficient R≥0.990.
1. The kit can be used for in vitro diagnosis only.
2. Test card and buffer solution are single-use and they cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.
5. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.
6. The kit used should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.
|cat#.||Product item||Specimen||Reaction Time||Measure Range||Clinical Range||Itended Use|
|1||cTnI||WB/Serum/Plasma||12min.||0.1-40ng/ml||<0.3ng/ml||several heart diseases including myocardial infarction and heart failure.|
|2||Myo||WB/Serum/Plasma||12min.||5-400ng/ml||<58ng/ml||acute myocardial infarction (AMI) in early stage.|
|3||CK-MB||WB/Serum/Plasma||12min.||1-200ng/ml||<5ng/ml||acute myocardial infarction (AMI) in early stage.|
|heart failure .|
|5||D-Dimer||WB/Plasma||10min.||40-10000ng/ml||<500ng/ml||disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc.|
|6||cTnI+Myo+CKMB||WB/Serum/Plasma||12min.||same with single item||same with single item||Triple marker of myocardial infarction.|
|7||ST2||WB/Serum/Plasma||10min.||10-400ng/ml||<35ng/ml||heart failure .|
|8||Lp-PLA2||WB/Serum/Plasma||10min.||10-900ng/ml||<175ng/ml||Risk evaluation of ACS and atherosclerotic ischemic stroke patients.|
|9||S100-β||WB/Serum/Plasma||10min.||0.05-10ng/ml||<0.2ng/ml||Cerebral infarction, cerebral injury.|
|10||CRP / hs-CRP||WB/Serum/Plasma||3min.||0.5-200mg/L||CRP<10mg/L,hs-CRP<1mg/L||nonspecficity inflammatory marker.|
|13||CRP+SAA||WB/Serum/Plasma||5min.||same with single item||same with single item||inflammation&infection.|
|15||TSH||Serum/Plasma||15min.||0.3-100mU/L||0.35-5mU/L||hyperthyroidism and hypothyroidism|
|21||CEA||Serum/Plasma||15min.||1-200ng/ml||<5ng/ml||colon cancer, colorectal cancer,etc.|
|22||NSE||Serum/Plasma||15min.||1-400ng/ml||<16ng/ml||non-small cell lung cancer|
|23||FOB||fecal specimens||10min.||50-1000ng/ml||<100ng/ml||Abnormal recessive gastrointestinal bleeding|
|24||PG II||Serum/Plasma||15min.||1-100ug/L||PGI/PGII>3.0||gastric abnormalities|
|25||PG I||Serum/Plasma||15min.||2.5-200ug/L||>70ng/ml||gastric abnormalities|
|29||CA15-3||Serum/Plasma||15min.||10-400U/ml||< 25 U/mL||breast cancer|
|30||HE4||Serum/Plasma||15min.||50-2000pmol/L||<140 pmol/L||ovarian cancer|
|31||CA19-9||Serum/Plasma||15min.||10-400U/ml||< 27 U/mL||pancreatic cancer|
|32||β-HCG||Serum/Plasma||15min.||5-400mIU/ml||<10 mIU/mL||Early pregrancy, ectopic HCG cancer,incomplete abortion|
|33||CK19(Cyfra21-1)||Serum/Plasma||15min.||0.5-50ng/ml||<2.5ng/ml||non-small cell lung cancer|
|34||HCG / β-HCG||Serum/Plasma||10min.||5-20000mIU/ml||<5 mIU/mL||early pregrancy.|
|35||AMH||Serum/Plasma||10min.||0.1-16ng/ml||Male: 20-60 years old, 0.92-13.89 ng/mL
Female: 20-29 years old, 0.88-10.35 ng/mL
30-39 years old, 0.31-7.86 ng/mL 40 -50 years old, <5. 07 ng/mL
|ovarian reserve level|
|36||FOB||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|37||TRF||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|38||FOB+TRF||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|41||Covid-19 Antigen||nasal swab, throat swab or nasal wash/aspirate specimens||15min.||qualitative||qualitative||respiratory tract|
|42||Covid-19 Ab IgG/IgM||WB/Serum/Plasma||15min.||qualitative||qualitative||respiratory tract|
|43||FluA||nasal swab, throat swab or nasal wash/aspirate specimens||15min.||qualitative||qualitative||respiratory tract|
|44||FluB||nasal swab, throat swab or nasal wash/aspirate specimens||15min.||qualitative||qualitative||respiratory tract|
|46||NGAL||Urine||10min.||10-1500ng/mL||<132ng/mL||acute kidney injury.|
|iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia|
Storage and expiry date
Storage: Store at 4-30 ℃ in dark, sealed, dry place, no frozen.
Expiry date: 12 months; date of production is on box.
Why Choose WWHS
Our company's main business is INFRARED fluorescent POCT. The main application scenarios of POCT include emergency department, ICU, chest pain center and stroke center, operating room, and various departments of grade hospitals. Community health, outpatient and other primary medical institutions at all levels; Pharmacies, home use and other organizations and individuals targeted at end customers. POCT is characterized by its simplicity and speed, freedom from application scenarios, and high cost performance. However, the current pain point of POCT industry lies in how to solve the problems of low sensitivity and poor precision faced by POCT products.
1 Wide-Range Diagnostics, It can be used in following areas
1) Department of thoracic Surgery
2) Clinical Laboratory
3) Department of Emergency
4) First Aid Community Hospital
5) Department of Respiration
7) Department of cardiology
8) Department of Geriatrics
2 Simple Procedure To Operate
1) Sample Can Be Plasma&whole Blood
2) Choose Internal Or External According To Needs
3) Single&Batch Processing
Q: What's the minimum order quantity (MOQ)?
A: For most of our medical products, even order for only one unit is warmly welcomed.
Q: Can you do OEM/ private label?
A: Of course we can do OEM/private label for you.
Q: How about your delivery time?
A: 2~10 day depends your order quantity.
Q: What is your terms of delivery?
A: DHL, UPS, FedEx, TNT, EMS, customer's freight forwarder is also available.
Q: What is your terms of payment?
A: Trade Assurance, T/T in advance, L/C, Western union, paypal
Please suggest your preferred payment method.
Q: Do you have certification?
A: ISO13485, CE
Q: Do you test all your goods before delivery?
A: Yes, we have 100% test before delivery
Q:How about after-sale serive ?
A:We will send you any parts within 15 months warranty, and supply you technology support for long time, solve problem as soon as possible .
Send your inquiry directly to us