Diagnostic Test

• Classification: Detection Diagonistic
• Type: Diagonistic Kit for Detection
• Certification: CE
• Group: All Peoples
• Transport Package: 50tests/Kit
• Trademark: Weimi
• Model NO.: IgM
• Origin: Guangzhou, China
• Production Capacity: 10000PCS/Day

Product Description

 test kit 
Diagnostic  Kit  for  IgM /IgG (Colloidal  Gold)




Package size
1 test/kit, 10 tests/kit, 20 tests/kit, 50tests/kit and 100 tests/kit.

Intended use
This product is used to qualitative detection of the presence of IgG antibody to V-2 in Human serum, plasma and/or whole blood.
The  common  symptoms  are  fever,  cough,  polypnea  and anhelation  when  infected  with  .  In  more  serious cases, infection may cause pneumonia, severe acute respiratory syndrome, renal failure and even death.  can be excreted through respiratory secretions and transmitted by air droplet. Infection may be caused by saliva, sneeze and contact.
Principle
A Monoclonal Mouse Anti-Human IgG conjugated to colloidal gold and embedded in the sample pad reacts with the IgG antibody  to  present  in  whole  blood,  serum  or plasma forming conjugate/ antibody complex.
As the mixture is allowed to migrate along the test strip, the conjugate/ antibody complex is captured by recombinan antigen immobilized on a membrane forming a colored test line in the test region.


Component

1. Cassette

2. Sample diluent

3. Pipette

Note: Do not interchange reagents from different lot of kit.



Storage and shelf life
Store at 2~30 ºC in sealed dark and dry place. Do not freeze. The shelf life is 18 months.
Samples requirement

1. Sample: Serum, plasma or whole blood

2. Sample collection

2.1 Collect serum or plasma specimens following regular clinical
laboratory  procedures.  Only  those  specimens  that  are  clean,


clear and with good fluidity can be used for the assay. Those specimens that are apparently hemolyzed, extremely thickened or with very high fat leval are NOT suitable for the assay.
2.2 Collect whole blood specimens following regular clinical laboratory procedures. Anticoagulant tube with EDTA or Sodium Citrate must be used for collecting whole blood samples.
2.3 Collect peripheral blood following regular clinical laboratory procedures.  The  first  drop  blood  was  removed  by  Dry  cotton ball.
3. Storage:  A specimen should be refrigerated  if not used the same day of collection. Specimens should be frozen if not used within 7 days of collecting. Specimen should be stored at -80ºC or  lower  if  not  used  within  in  3  months.  Avoid  freezing  and thawing the specimens more than 2-3 times.
4. Transportation: Samples must be transported in seal and refrigeration.


Test procedure
Read the insert carefully before use. Bring the Cassette, Sample
Diluent and samples to room temperature.
Dispense 10ul serum/plasma/whole blood into sampling well of Cassette.  Then  Dispense  100ul  Sample  diluent  into  sampling well of Cassette
Interpret the result at 15 minutes. Please do not judge the result after 20 minutes.

 

 

Results interpretion









Positive:  Both  test  band  and  control  band  appear  on  the membrane.
Negative: Only the control band appears on the membrane. Invalidity: No control band appears on the membrane.
Note: Within the specified time, regardless of the depth of the color, even if only a very weak band should also be judged as positive results.

 

 

Limitations


1. This product is qualitative test of IgM antibody

2. The result only show the presence or non-presence of IgG to The final diagnosis of the patient can not simply rely on the results of this experiment, the comprehensive judgments must be made combined with clinical examination.
3. The sensitivity depends on the concentration of IgG antibody to in the sample. Samples with low concentration may show negative result.

Performance
Positive control

All 5 positive controls should show positive result.

Negative controls

All 10 negative controls should show negative result.

Limit of Detection

4 samples, L1, L2, L3 and L4 were tested. L1, L2 and L3 show positive result and L4 shows negative result.
Repeatability

2 Controls, Q1 and Q2, are tested in 10 times. The results should be positive and the color is identical.


Note:

1.  This  product  is  only  for  In  vitro  diagnosis.  Please  operate following insert. Do not use after the expiry and damaged product.
2. Do not interchange reagents from different lot of kit.

3. Do not use water or purified water as negative control.

4. The cassette must be used within 1 hour after taking out the sealed bag. If the surrounding temperature is higher than 30 ºC  or the humidity is high, The cassette must be used immediately after
taking out the sealed bag.

5. Applying sufficient amount of samples diluents is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after 30 seconds, add one more drop of diluents.
6. The collection, processing, storage, discarding of the sample and the use of the reagent in the kit should take appropriate precautions. All the samples, reagents, and control substance should be handled
as infectious substances..


References
[1] Na Zhu.A Novelfrom Patients with Pneumonia in China, 2019. The new england journal of medicine. January 24,
2020.