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One Step Fertility Test Kit 300 Tests / Hour AMH Rapid Test Cassette

One Step Fertility Test Kit 300 Tests / Hour AMH Rapid Test Cassette

Brand Name:WWHS
Certification:ISO 13485, CE
Model Number:AMH
Minimum Order Quantity:500
Delivery Time:7 Days
Place of Origin:CN
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Location: Shenzhen China
Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen
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Product Details

【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】

NameQuantityComponent
Test cards25The 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 diluent25 (0.3mL/ tube)Phosphate buffer
ID card1With 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.

SexAgeReference Interval (ng/mL)
Adult male0.92~13.89
Female20~290.88~10.35
30~390.31~7.86
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.

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.



PRINCIPLE:

The AMH Rapid Test Cassette (Whole Blood/Serum/Plasma) is a semi-quantitative membrane based
immunoassay for the detection of anti-Mullerian Hormone in whole blood, serum or plasma. In this test
procedure, anti-AMH antibodies is immobilized in the test line region of the test. After specimen is
added to the specimen well of the cassette, it reacts with anti-AMH antibody coated colloid gold
particles in the test. This mixture migrates chromatographically along the length of the test and
interacts with the immobilized anti-AMH antibodies. If the specimen contains AMH, a colored line will
appear in the test line region indicating a positive result. If the specimen does not contain AMH, a
colored line will not appear in this region indicating a negative result. To serve as a procedural
control, a colored line will always appear in the control line region, indicating that proper volume
of specimen has been added and membrane wicking has occurred.


Assay list     
Cardiac     
cat#.Product itemSpecimenReaction TimeMeasure RangeClinical RangeItended Use
1cTnIWB/Serum/Plasma12min.0.1-40ng/ml<0.3ng/mlseveral heart diseases including myocardial infarction and heart failure.
2MyoWB/Serum/Plasma12min.5-400ng/ml<58ng/mlacute myocardial infarction (AMI) in early stage.
3CK-MBWB/Serum/Plasma12min.1-200ng/ml<5ng/mlacute myocardial infarction (AMI) in early stage.
4NT-proBNPWB/Serum/Plasma10min.20-35000pg/mlUnder 75:0~347pg/mL,
Over 75:0~449pg/mL
heart failure .
5D-DimerWB/Plasma10min.40-10000ng/ml<500ng/mldisseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc.
6cTnI+Myo+CKMBWB/Serum/Plasma12min.same with single itemsame with single itemTriple marker of myocardial infarction.
7ST2WB/Serum/Plasma10min.10-400ng/ml<35ng/mlheart failure .
8Lp-PLA2WB/Serum/Plasma10min.10-900ng/ml<175ng/mlRisk evaluation of ACS and atherosclerotic ischemic stroke patients.
9S100-βWB/Serum/Plasma10min.0.05-10ng/ml<0.2ng/mlCerebral infarction, cerebral injury.
Inflammation     
10CRP / hs-CRPWB/Serum/Plasma3min.0.5-200mg/LCRP<10mg/L,hs-CRP<1mg/Lnonspecficity inflammatory marker.
11SAASerum5min.1-200mg/L<10mg/Linflammation&infection.
12PCTWB/Serum/Plasma10min.0.2-100ng/ml<0.5ng/mlSepsis
13CRP+SAAWB/Serum/Plasma5min.same with single itemsame with single iteminflammation&infection.
14IL-6WB/Serum/Plasma10min.5-4000pg/ml10pg/mldiabetes,rheumatoid arthritis,etc
Thyroid Hormone     
15TSHSerum/Plasma15min.0.3-100mU/L0.35-5mU/Lhyperthyroidism and hypothyroidism
16TT3Serum/Plasma15min.0.5-10nmol/L1.3-3.1nmol/Lthyroid dysfunction
17TT4Serum/Plasma15min.5-300nmol/L66-181nmol/Lthyroid dysfunction
18FT3Serum/Plasma15min.1-100pmol/L4-10pmol/Lthyroid dysfunction
19FT4Serum/Plasma15min.5-300pmol/L19-39pmol/Lthyroid dysfunction
Tumor Marker     
20AFPSerum/Plasma15min.2.5-200ng/ml<20ng/mlpregnancy cancer
21CEASerum/Plasma15min.1-200ng/ml<5ng/mlcolon cancer, colorectal cancer,etc.
22NSESerum/Plasma15min.1-400ng/ml<16ng/mlnon-small cell lung cancer
23FOBfecal specimens10min.50-1000ng/ml<100ng/mlAbnormal recessive gastrointestinal bleeding
24PG IISerum/Plasma15min.1-100ug/LPGI/PGII>3.0gastric abnormalities
25PG ISerum/Plasma15min.2.5-200ug/L>70ng/mlgastric abnormalities
26TPSASerum/Plasma15min.0.5-40ng/ml<4ng/mlprostate cancer
27FPSASerum/Plasma15min.0.1-10ng/ml<1ng/mlprostate cancer
28CA12-5Serum/Plasma15min.20-500U/ml<35U/mlovarian cancer
29CA15-3Serum/Plasma15min.10-400U/ml< 25 U/mLbreast cancer
30HE4Serum/Plasma15min.50-2000pmol/L<140 pmol/Lovarian cancer
31CA19-9Serum/Plasma15min.10-400U/ml< 27 U/mLpancreatic cancer
32β-HCGSerum/Plasma15min.5-400mIU/ml<10 mIU/mLEarly pregrancy, ectopic HCG cancer,incomplete abortion
33CK19(Cyfra21-1)Serum/Plasma15min.0.5-50ng/ml<2.5ng/mlnon-small cell lung cancer
Fertility     
34HCG / β-HCGSerum/Plasma10min.5-20000mIU/ml<5 mIU/mLearly pregrancy.
35AMHSerum/Plasma10min.0.1-16ng/mlMale: 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      
36FOBfecal specimens10min.qualitativequalitativegastrointestinal hemorrhage.
37TRFfecal specimens10min.qualitativequalitativegastrointestinal hemorrhage.
38FOB+TRFfecal specimens10min.qualitativequalitativegastrointestinal hemorrhage.
Infection      
39C.PneumoniaWB/Serum/Plasma15min.qualitativequalitativeCP infection
40M.PneumoniaWB/Serum/Plasma15min.qualitativequalitativeMP infection
41Covid-19 Antigennasal swab, throat swab or nasal wash/aspirate specimens15min.qualitativequalitativerespiratory tract
42Covid-19 Ab IgG/IgMWB/Serum/Plasma15min.qualitativequalitativerespiratory tract
43FluAnasal swab, throat swab or nasal wash/aspirate specimens15min.qualitativequalitativerespiratory tract
44FluBnasal swab, throat swab or nasal wash/aspirate specimens15min.qualitativequalitativerespiratory tract
Renal Injury      
45CysCWB/Serum/Plasma5min.0.4-9mg/L0.5-1.1mg/Lrenal function
46NGALUrine10min.10-1500ng/mL<132ng/mLacute kidney injury.
Other      
47FERRSerum5min.10-500ng/mlMale:24ng/mL~335ng/mL,
Female:11ng/mL~307ng/mL
iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia
48HbA1cWB10min.4%-14%4%-6%diabetes
49VDSerum/Plasma15min.8-70ng/mL19-57ng/mLfetation


About NIR-1000 Dry Fluoroimmunoassay Analyser


It is a fluorescence immunochromatographic analysing system with internal temperature control,
which can help diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.


Feature


Immunofluorescence technology
Testing time less than 15 minutes


Smarter Operation


1. High Quality: Imported Major Components with Advanced German Technology

2.User-Friendly Design: 7 Inch touch screen, great touch feeling, simple graphic interface

3. Built-In Lithium Battery: High Mobility for first aid&amulance

4. Two Test Mode: Internal&External mode for different clinical needs

5. Smart Report: Auto Printing

6. Visual Results: Able to connect with LIH/HIS


FAQ


1.How to buy your products?Do you have distributor in our country?

You can buy the products from our company directly.Normally the procedure is:Sign the contact ,payment byT/T, contact the shipping company to delivery the goods to your country.


2. What is the warranty?

The free warranty is one year from the day of Commissioning qualified.


3.Can we visit your country?

Of course,we will prepare for everything in advance if it is necessary .Generally,it is require that customers must have build agency relationship or business relationship with our company.


4.How long is the validity of quotation?

Generally,our price is valid within one month from the date of quotation .The price will be adjusted appropriately according to the price fluctuation of raw material and changes in market.


5.Do you have the CE certificate?

Yes, most of our products have the CE certificate.

China One Step Fertility Test Kit 300 Tests / Hour AMH Rapid Test Cassette supplier

One Step Fertility Test Kit 300 Tests / Hour AMH Rapid Test Cassette

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