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Anti Mullerian Hormone Rapid Test Kit For Clinical Diagnostic

Anti Mullerian Hormone Rapid Test Kit For Clinical Diagnostic

  • Anti Mullerian Hormone Rapid Test Kit For Clinical Diagnostic
  • Anti Mullerian Hormone Rapid Test Kit For Clinical Diagnostic
  • Anti Mullerian Hormone Rapid Test Kit For Clinical Diagnostic
  • Anti Mullerian Hormone Rapid Test Kit For Clinical Diagnostic
  • Anti Mullerian Hormone Rapid Test Kit For Clinical Diagnostic
Anti Mullerian Hormone Rapid Test Kit For Clinical Diagnostic
Product Details:
Place of Origin: CN
Brand Name: WWHS
Certification: ISO 13485, CE
Model Number: Anti Mullerian Hrmone
Payment & Shipping Terms:
Minimum Order Quantity: 2000
Price: US 1.50-2.50 Kit
Packaging Details: Colorful Paper Box
Delivery Time: 7 Days
Payment Terms: L/C, T/T
Supply Ability: 20000 Kits per Week
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Detailed Product Description
Product Name: AMH Rapid Test Kit Sample Buffer: 25 Vials
Linearity Range: Within The Specified Linearity Range (4.0%,14.0%) Storage: Room Temperature
Warranty: 12 Months Applicable Instrument: NIR-1000 Dry Fluoroimmunoassay Analyser
Manufacturer: WWHS Biotech INC Reactivity: Human
Feature: High Sensitivity Annual Capacity: 3 Million A Year
High Light:

Clinical Diagnostic Hormone Rapid Test Kit

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Anti Mullerian Hormone Rapid Test Kit

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Anti Mullerian Hormone Test Kit

【Product Name】

Anti-Mullerian Hormone (AMH) Rapid Quantitative Test (Fluorescence immunoassay)

 

【Packing Specification】

25 Tests/kit

 

【Intended Use】

The kit is used for quantitative determination of AMH in human whole blood,serum or plasma. It is mainly used to evaluate ovarian reserve and assist in the diagnosis of polycystic ovary syndrome .

 

【Test principle】

The Diagnostic Kit for AMH is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of AMH. The AMH antigen in the sample was first bound with the conjugated compound of fluorescent labeled AMH monoclonal antibody, then moved and combined with another AMH 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 The product consists of fluorescent pat (coated with fluorescently-labeled AMH antibody), nitrocellulose membrane (coated with AMH antibody and Goat anti mouse IgG antibody), absorbent paper and PVC soleplate.
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. Plasma, serum and whole blood can be used as samples. The whole blood should be collected in a tube containing heparin, citrate or EDTA as the anticoagulant. If the serum procedure is used, collect blood in a tube without anticoagulant and allow clotting. Hemolyzed samples should not be used.
  2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
  3. It is highly recommended to use fresh samples instead of keeping the samples at room temperature for a long time. After samples were collected, the detection should be completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored at 2℃~8℃ for 24 hours. Plasma and serum samples can be stored at 2℃~ 8℃ for 7 days, -20℃for 30 days.
  4. Before testing, the sample should return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use. Repeated freeze-thaw cycles should be avoided.

 

【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 according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the information card. The information card is inserted before use, so it is not necessary to calibrate again, and the test can be carried out only after the quality control is passed. Otherwise, the cause should be found out before testing.)
  3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
  4. Place the test card on a clean horizontal table and mark it horizontally.
  5. Mix 100µL of sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
  6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 10 minutes after addition of samples, then dispose of used test appropriately.

 

【Reference Interval】

Test and analyze the AMH from healthy people serum, and use the 95 percentile method to determine the AMH reference interval.

Sex Age Reference Interval (ng/mL)
Adult male 0.92~13.89
Female 20~29 0.88~10.35
30~39 0.31~7.86
40~50 ≤5.07
 

It is strongly recommended that each laboratory should determine its own normal and abnormal values.

 

【Interpretation of test results】

  1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
  2. For samples whose AMH concentration is lower than 0.10ng/mL and higher than 16.00ng/mL, test result is “0.10ng/mL” and “16.00ng/mL” respectively.

 

【Limitation of test 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 triglyceride content in the sample does not exceed 15mg/mL, the hemoglobin content does not exceed 10mg/mL, the bilirubin content does not exceed 0.5mg/mL, the cholesterol does not exceed 10mg/mL, and the relative deviation of the measurement results does not exceed ±15.0%.

4. When AMH concentration of samples reaches 160.00ng/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.

6. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±10.0%.

7. For samples exceeding the linearity range, test cannot be conducted after dilution.

8. Inhibin A (≤100ng/mL), Activin A (≤100ng/mL), LH (≤500mIU/mL), FSH (≤500mIU/mL) several commonly used drugs in the sample (Cefoxitin ≤2500mg/ L. Metformin≤2000mg/L, ibuprofen≤500mg/L, rifampicin≤60mg/L, doxycycline≤50mg/L), the relative deviation of the measurement results does not exceed ±15.0%

 

【Performance】

1. Limits of detection

No higher than 0.10ng/mL

2. Accuracy

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

  1. Precision

The within and between assay coefficient of variations are within 15%.

  1. Linear range

Within the linear range (0.10 ~ 16.00) 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.

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.

Anti Mullerian Hormone Rapid Test Kit For Clinical Diagnostic 0

 

Other WWHS Assay Items

 

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.

 

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Test Method

 

1. Please thoroughly read the specification before test. Frozen test card and sample should be placed at room temperature (15-30) ℃ for at least 30min before use.
2. Start NIR-1000 dry fluoroimmunoassay analyser and verify quality control according to the specification.
3. The quality of reagent is controlled using internal quality control product (not provided) of the company and result should be controllable.
4. Take out the test card from the aluminum foil bag and use it within 15min
5. Place the test card on a clean horizontal table top and label it.
6. Take 10μL of sample and add it into HbA1c sample buffer (1.00mL). Then, mix the solution evenly, take 100μL of the solution and add it into the well.
7. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, keep time for 10min and press 【Instant test】. The analyser will judge and read the test result automatically. Or press 【Fixed time test】 to keep time for 10min automatically. The analyser will judge and read the test result automatically and display it in the screen.


Applicable Instrument


WWHS NIR-1000 dry fluoroimmunoassay analyser

Advantage

Immunofluorescence technology
Testing time less than 15 minutes
Easy-to-use touch-screen platform,multi-language system

 

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 .

Contact Details
WWHS Biotech.Inc(exclusive marketed by Dawin)

Contact Person: sales

Tel: +8613823276027

Send your inquiry directly to us (0 / 3000)

Contact

Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen

Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen