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Mycoplasma Pneumoniae IgM Test Kit 3000 Tests/Day For Renal Injury Detection

Mycoplasma Pneumoniae IgM Test Kit 3000 Tests/Day For Renal Injury Detection

  • Mycoplasma Pneumoniae IgM Test Kit 3000 Tests/Day For Renal Injury Detection
  • Mycoplasma Pneumoniae IgM Test Kit 3000 Tests/Day For Renal Injury Detection
Mycoplasma Pneumoniae IgM Test Kit 3000 Tests/Day For Renal Injury Detection
Product Details:
Place of Origin: CN
Brand Name: WWHS
Certification: CE
Model Number: Mycoplasma Pneumoniae IgM
Payment & Shipping Terms:
Minimum Order Quantity: 1000
Price: US 1.50 - 2.50 Kit
Packaging Details: Colorful Paper Box
Delivery Time: 7 Days
Payment Terms: T/T
Supply Ability: 20000 Kits per Week
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Detailed Product Description
Product Name: M.Pneumoniae Rapid Test Kit Type: One Step Assay
Storage: At Room Temperature Feature: High Sensitivity
Formal Name: Mycoplasma Pneumoniae IgM Rapid Test Reactivity: Human
Manufacturer: WWHS Biotech INC Throughput: 3000 Tests/Day
Usage: Renal Injury Detection Keywords: High Stability, High Accuracy
High Light:

Mycoplasma Pneumoniae IgM Test Kit

,

3000 Tests/Day IGM Test Kit

,

Igm Rapid Test Cassette

【Product name】

Mycoplasma Pneumoniae IgM Antibody Rapid Test Kit (Colloidal Gold)

 

【Package specification】

25 Tests/kit

 

【Intended use】

It is used for qualitative detection of mycoplasma pneumoniae IgM antibody in human serum, plasma, and whole blood samples. It is applicable to the auxiliary diagnosis of mycoplasma pneumoniae infection.

 

【Inspection principle】

The principle of chromatographic capture method is applied to qualitatively detect Mycoplasma pneumoniae IgM antibody in human plasma, serum and whole blood. After the sample is added into the sample hole, the anti Mycoplasma pneumoniae antibody (IgM) in the sample will bind to the gold labeled Mycoplasma pneumoniae antigen after re dissolution and migrate upward by chromatography. When it migrates to the detection line, it will bind to the anti human IgM (u-chain) antibody on the detection line, Form a visible gold labeled Mycoplasma pneumoniae antigen anti Mycoplasma pneumoniae IgM antibody anti human IgM antibody complex. Anti Mycoplasma pneumoniae IgM antibody negative samples did not form gold labeled complexes.

 

【Components】

Name Quantity Component
Test cards 25

a) Anti human IgM (U chain) antibody (fixed in the T region of nitrocellulose membrane);

b) Sheep anti human Mycoplasma pneumoniae antigen polyclonal antibody (fixed in the C region of nitrocellulose membrane);

c) Colloidal gold labeled Mycoplasma pneumoniae antigen;

d) Other test strip supports.

Sample diluent 25(1mL/tube) Phosphate buffer
 

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.

 

【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】

Please read the operating instructions carefully before testing. Before the test, please restore all reagents to room temperature, and the reagents shall be carried out at room temperature.

1. Open it along the opening of the aluminum foil bag, take out the reagent card and place it flat.

2. Add 10 µL of serum or plasma to be tested (20 µL of whole blood) into the sampling hole of the test card, and slowly add 3 drop (or 80 µL) of sample buffer.

3. Observe the displayed results within 15 ~ 20 minutes, and the displayed results after more than 20 minutes are invalid.

 

【Interpretation of results】

1. (a) Both the control line and the test line were positive; (b) Only the control line is negative; (c) The control line is not displayed, so this experiment is invalid.

2. The positive results show that the sample contains Mycoplasma pneumoniae IgM antibody. It should also be combined with other clinical indicators to determine whether the patient is infected with Mycoplasma pneumoniae.

3. The negative result shows that no Mycoplasma pneumoniae IgM antibody is detected, but if the content of Mycoplasma pneumoniae IgM antibody in the sample is too low, which is lower than the detection limit of this kit, although the test result is negative, the possibility of infection with Mycoplasma pneumoniae is not ruled out.

 

 

【Limitations of methods】

1. This reagent is only used for testing serum, plasma and whole blood samples.

2. The test results of this reagent are only for clinical reference and shall not be used as the only basis for clinical diagnosis and treatment. The clinical management of patients shall be comprehensively considered in combination with their symptoms / signs, medical history, other laboratory tests and treatment reactions.

3. The substance detected in this test card is MP IgM antibody. In the window period of MP acute infection or when the titer of MP IgM in the sample is lower than the detection limit of this kit, incorrect negative results may be obtained, and the patient should be prompted to recheck within 7-14 days.

4. MP IgM positive not only occurred in the primary interference of Mycoplasma pneumoniae, but also in the secondary infection.

5. Cross reactivity: no cross reactivity with serum samples of patients infected with Ureaplasma urealyticum, Mycoplasma genitalium, Mycoplasma hominis, Streptococcus pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Mycobacterium tuberculosis, Legionella pneumophila and Pseudomonas aeruginosa, and no cross reactivity with syncytial virus, adenovirus, influenza virus There was no cross reaction in serum samples of patients infected with parainfluenza virus.

6. When the content of triglyceride in the sample does not exceed 15mg / ml, the content of hemoglobin does not exceed 5mg / ml, the content of bilirubin does not exceed 0.5mg/ml, and the RF concentration is less than 2000iu / ml, it has no effect on the test results.

7. When the human anti mouse concentration in the sample is less than 50NG / ml, HAMA effect will not occur.

 

【Performance】

1. Positive coincidence rate: all 10 positive quality control samples were positive, and the positive coincidence rate was 100%.

2. Negative coincidence rate: all 10 negative quality control samples were positive, and the negative coincidence rate was 100%.

3. Repeatability: the judgment results of yin and Yang of the same reference material shall be consistent, and the apparent chromaticity shall be consistent.

4. Difference between batches: the test results between batches shall be completely consistent, and the apparent chromaticity shall be consistent.

5. Detection limit: not higher than 5IU/ml.

 

cat#. Product Item Specimen Reaction Time Measure Range Clinical Range Itended Use
Cardiac          
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 Maker          
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
36 LH Serum/Plasma 20min. 1-200mIU/ml Male: 1.70-8.60 mIU/mL;
Female:
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
reproductive dysfunction
37 FSH Serum/Plasma 20min. 1-100mIU/ml Male: 1.50-12.40 mIU/mL
Female:
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
reproductive system
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.
39 Progesterone Serum/Plasma 20min. 1-50ng/ml   pregrancy progesterone
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
41 SHBG Serum/Plasma 20min. 1-200nmol/L 15-120nmol/L unphysiological diseases.
42 E2 Serum/Plasma 20min. 10-1000pg/ml Male: <85 pg/mL
Female:
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
ovarian vitality.
Gastrointestinal            
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.
Infection            
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
Renal injury            
50 CysC WB/Serum/Plasma 5min. 0.4-9mg/L 0.5-1.1mg/L renal function
51 NGAL Urine 10min. 10-1500ng/mL <132ng/mL acute kidney injury.
Other            
52 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
53 HbA1c WB 10min. 4%-14% 4%-6% diabetes
54 VD Serum/Plasma 15min. 8-70ng/mL 19-57ng/mL fetation

 

Mycoplasma Pneumoniae IgM Test Kit 3000 Tests/Day For Renal Injury Detection 0Mycoplasma Pneumoniae IgM Test Kit 3000 Tests/Day For Renal Injury Detection 1

Mycoplasma Pneumoniae IgM Test Kit 3000 Tests/Day For Renal Injury Detection 2

 

 

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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