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WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection

WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection

β-HCG Fertility Test Kit

WWHS Fertility Test Kit

HCG Rapid Test Cassette

Place of Origin:

CN

Brand Name:

WWHS

Certification:

ISO 13485, CE

Model Number:

β-HCG

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Product Details
Features:
High Accuracy
Product Name:
β-HCG Rapid Quantitative Test Kit
Pack Size:
25 Tests
Sample Diluent:
Whole Blood Buffer
Storage:
4-30℃
Format:
Cassette
Reactivity:
Human
Advantage:
High Sensitivity
Application In:
WWHS NIR-1000 Dry Fluoroimmunoassay Analyser
Supply Ability:
2 Million A Year
Type:
Fast Fertility Test Kit
Manufacturer:
WWHS Biotech INC
Payment & Shipping Terms
Minimum Order Quantity
500
Price
US 2.80 Kit
Packaging Details
Paper Box
Delivery Time
7 Days
Product Description

WWHS β-HCG Rapid Quantitative Test Kit For Fertility Detection

bHCG.pdf

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.

 

 

【Product name】

Diagnostic Kit for Neutrophil gelatinase-associtated lipocalin(Immunochromatographic assay)

 

【Packing specification】

25 Tests/kit

 

【Intended use】

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.

 

【Test principle】

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.

 

【Components】

Name Quantity Component
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.

 

【Applicable instrument】

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

 

【Sample requirements】

  1. Urine can be used as samples.
  2. The middle urine samples of random urine were collected for detection.
  3. After sample collection, clear urine samples can be stored at room temperature for 24 hours and at 2 ℃ ~ 8 ℃ for 7 days; It can be stored at - 20 ℃ for 30 days.

 

【Test procedure】

  1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.
  2. Start NIR-1000 dry fluoroimmunoassay analyser and correctly select the corresponding sample type on the instrument.
  3. Take out the ID card, make sure that the batch number of the ID card is consistent with that of the test card, and insert the ID card into the ID card port of the instrument.
  4. Take out the test card from the aluminum foil bag and use it within 15 minutes.
  5. Place the test card on a clean horizontal table and mark it horizontally.
  6. Mix 100 µL of urine sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
  7. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser and click the “instant test” button to read the results at 10 minutes after addition of samples.

 

【Reference interval】

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】

  1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
  2. For samples with NGAL concentration lower than 10.00ng/mL and higher than 1500.00ng/mL, the detection results are reported as "<10.00ng/mL "and ">1500.00ng/mL ", respectively.

 

【Limitation of method】

  1. This kit is only used to detect human serum/plasma/whole blood samples
  2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
  3. The content of triglyceride in the sample shall not exceed 30mg/mL, the content of hemoglobin shall not exceed 10mg/mL, and the content of bilirubin shall not exceed 0.25mg/mL, and the relative deviation of the test results shall not exceed ±15%.

4. When the concentration of NGAL in the sample is less than 2000ng/mL, there is no hook effect.

  1. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
  2. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±15.0%.

 

【Performance】

1. Limits of detection

No higher than 10.00 ng/mL.

2. Accuracy

The relative deviation from the target value is limited to ±15.0%.

3. Repeatability

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.

 

【Note】

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.

 

WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection 0WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection 1WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection 2WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection 3

 

Assay list          
Cardiac          
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.
4 NT-proBNP WB/Serum/Plasma 10min. 20-35000pg/ml Under 75:0~347pg/mL,
Over 75:0~449pg/mL
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.
Inflammation          
10 CRP / hs-CRP WB/Serum/Plasma 3min. 0.5-200mg/L CRP<10mg/L,hs-CRP<1mg/L nonspecficity inflammatory marker.
11 SAA Serum 5min. 1-200mg/L <10mg/L inflammation&infection.
12 PCT WB/Serum/Plasma 10min. 0.2-100ng/ml <0.5ng/ml Sepsis
13 CRP+SAA WB/Serum/Plasma 5min. same with single item same with single item inflammation&infection.
14 IL-6 WB/Serum/Plasma 10min. 5-4000pg/ml 10pg/ml diabetes,rheumatoid arthritis,etc
Thyroid Hormone          
15 TSH Serum/Plasma 15min. 0.3-100mU/L 0.35-5mU/L hyperthyroidism and hypothyroidism
16 TT3 Serum/Plasma 15min. 0.5-10nmol/L 1.3-3.1nmol/L thyroid dysfunction
17 TT4 Serum/Plasma 15min. 5-300nmol/L 66-181nmol/L thyroid dysfunction
18 FT3 Serum/Plasma 15min. 1-100pmol/L 4-10pmol/L thyroid dysfunction
19 FT4 Serum/Plasma 15min. 5-300pmol/L 19-39pmol/L thyroid dysfunction
Tumor Marker          
20 AFP Serum/Plasma 15min. 2.5-200ng/ml <20ng/ml pregnancy cancer
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
26 TPSA Serum/Plasma 15min. 0.5-40ng/ml <4ng/ml prostate cancer
27 FPSA Serum/Plasma 15min. 0.1-10ng/ml <1ng/ml prostate cancer
28 CA12-5 Serum/Plasma 15min. 20-500U/ml <35U/ml ovarian cancer
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
Fertility          
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
Gastrointestinal            
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.
Infection            
39 C.Pneumonia WB/Serum/Plasma 15min. qualitative qualitative CP infection
40 M.Pneumonia WB/Serum/Plasma 15min. qualitative qualitative MP infection
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
Renal Injury            
45 CysC WB/Serum/Plasma 5min. 0.4-9mg/L 0.5-1.1mg/L renal function
46 NGAL Urine 10min. 10-1500ng/mL <132ng/mL acute kidney injury.
Other            
47 FERR Serum 5min. 10-500ng/ml Male:24ng/mL~335ng/mL,
Female:11ng/mL~307ng/mL
iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia
48 HbA1c WB 10min. 4%-14% 4%-6% diabetes
49 VD Serum/Plasma 15min. 8-70ng/mL 19-57ng/mL fetation

 

WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection 4WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection 5WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection 6WWHS Fertility Test Kit β-HCG Rapid Test Cassette For Fertility Detection 7

 

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.

 

Product Features

 

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

6) CCU/ICU

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

 

FAQ:

 

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

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