|Place of Origin:||CN|
|Certification:||ISO 13485, CE|
|Minimum Order Quantity:||1000|
|Price:||US 1.50-2.99 Kit|
|Packaging Details:||Colorful Paper Box|
|Delivery Time:||10 Days|
|Payment Terms:||L/C, T/T|
|Supply Ability:||20000 Kits per Week|
|Product Name:||AMH Rapid Quantitative Test Kit||Sample Buffer:||25 Vials|
|Warranty:||12 Months||Applicable Instruments:||NIR-1000 Dry Fluorescent Immunoassay Analyzer|
|Formal Name:||Anti Mullerian Hrmone||Reactivity:||Human|
|Inspection:||Fluorescence Immunoassay||Storage:||At Room Temperature|
|Advantage:||High Sensitivity||Annual Capacity:||3 Million A Year|
High Sensitivity AMH Test Kit,
CE Approval AMH Test Kit,
CE Anti Mullerian Hormone Test Kit
Anti-Mullerian Hormone (AMH) Rapid Quantitative Test (Fluorescence immunoassay)
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 .
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.
|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.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
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)|
It is strongly recommended that each laboratory should determine its own normal and abnormal values.
【Interpretation of test results】
【Limitation of test method】
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.
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%
1. Limits of detection
No higher than 0.10ng/mL
The relative deviation to the target value is limited to ±15.0%.
The within and between assay coefficient of variations are within 15%.
Within the linear range (0.10 ~ 16.00) 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||LH||Serum/Plasma||20min.||1-200mIU/ml||Male: 1.70-8.60 mIU/mL;
Follicular phase : 2.95 13.65 mIU/mL
Ovulation phase: 13.65-95.75 Miu/mL Luteal phase: 1.25-11.00 mIU/mL
Menopause phase: 8.24 -55.23 mIU/mL
|37||FSH||Serum/Plasma||20min.||1-100mIU/ml||Male: 1.50-12.40 mIU/mL
Follicular phase : 4.46-12.43 mIU/mL Ovulation phase: 4.88-20.96 mIU/mL Luteal phase: 1 .96-7.70 mIU/mL
Menopause phase: 22.70-130.00 mIU/mL
|38||Testosterone||Serum/Plasma||20min.||0.25-16ng/ml||Male: 20-49 years old, 1.61-8.41 ng/mL
>50 years old, <0.61 ng/mL
Female: 20-49 years old, <0.80ng/mL
>50 years old, <0.71 ng/mL
|sexual hormone disturbance and hypogonadism.|
|40||PRL||Serum/Plasma||20min.||1-200ng/ml||Female (non-pregnant): 4.60-25.07 ng/mL Male: 3.45-17.42 ng/mL||breastfeeding&abnormal lactation|
|42||E2||Serum/Plasma||20min.||10-1000pg/ml||Male: <85 pg/mL
Follicular Phase: 12-262 pg/mL
Ovulation: 40-396 pg/mL
Luteal Phase: 21-381 pg/mL
Menopause: <190 pg/mL
Pregnancy: >145 pg/mL
|43||FOB||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|44||TRF||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|45||FOB+TRF||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|46||Covid-19 Antigen||nasal swab, throat swab or nasal wash/aspirate specimens||15min.||qualitative||qualitative||respiratory tract|
|47||Covid-19 Ab IgG/IgM||WB/Serum/Plasma||15min.||qualitative||qualitative||respiratory tract|
|48||FluA||nasal swab, throat swab or nasal wash/aspirate specimens||15min.||qualitative||qualitative||respiratory tract|
|49||FluB||nasal swab, throat swab or nasal wash/aspirate specimens||15min.||qualitative||qualitative||respiratory tract|
|51||NGAL||Urine||10min.||10-1500ng/mL||<132ng/mL||acute kidney injury.|
|iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia|
Interpretation of 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 AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /ml", respectively.
Limitations of methods
1. This kit is only used to detect human 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 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.
4. When the concentration of AFP in the sample is less than 20000ng/ml, there is no hook effect.
5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. When RF concentration in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.
Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping.
WWHS NIR-1000 dry fluoroimmunoassay analyser
1. What is the MOQ?
Generally if you choose the different products, our minimum order qty. also will be different. One sample available.
2. What about the delivery time?
The goods need 7-21 work days to be made upon deposit.
3. Does your product have any warranty?
Yes, we offer 6 months limited warranty for our products.
Damage due to misuse, ill treatment and unauthorized modifications and repairs are not covered by our warranty.
4. What's your payment method?
We usually accept the payment methods include PayPal, TT, and Western Union.
50% deposit in advance and balance before shipping. Buyer can choose which payment ways that you accept.
PayPal is most useful and safe, please don’t refuse PayPal fee when you choose PayPal.
5. What's your shipping method?
We provide comprehensive shipping methods.
For small quantity orders we ship by DHL Air-Express, or EMS/TNT/UPS/FEDEX Express service, it is safe and fast.
For large quantity orders we ship by Air transportation or sea transportation, we can also ship order to buyer’s cargo agent in China.
Contact Person: sales
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