HAV lgM Antibody Test Cassette

  • Format:聽Cassette
  • Specimen:聽Serum/Plasma/Whole Blood
  • Size: 3.0mm, 4.0mm
  • Accuracy: over 99.5%
  • Results read within 15 minutes
  • Shelf time: 2 years
  • Description
  • Instruction for Use
  • Ordering Information
  • Inquiry

One step HAV lgM Antibody Test Cassette聽 is an in vitro diagnostic kit for the qualitative, presumptive detection of specific anti-HAV-IgM in human serum or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HAV infection.

 

Features

  • Fast read within 15 minutes
  • Accurate over 99.5%
  • Use easily and cost effectively
  • Visually interpreted

 

Packaging

Box of 25T, Ctn of 1000T

ONE STEP CASSETTE STYLE HAV IgM TEST (COLLOID GOLD)

INTRODUCTION

The one step cassette style HAV IgM test is a rapid test based on the principle of immunoassay combined with conjugated colloid gold technology. The HAV test is a diagnostic device for qualitative detection of anti-HAV IgM in human serum (or plasma) specimen.

 

SUMMARY

In acute infection period, anti-HAV IgM is present of high level in the patient鈥檚 sera. The IgM antibody titer is decreased significantly and even disappeared in convalescence period, instead IgG is present. Since cases of hepatitis A are not clinically distinguishable from other types of acute viral hepatitis, a correct diagnosis can be made by blood tests which detect the specific anti-viral antibodies.

 

SPECIMEN COLLECTION

For serum锛坥r plasma锛, collect blood into a container without anticoagulant. If the specimen cannot be tested on the day of collection, store the serum (or plasma) specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing.

 

TEST PROCEDURE

  1. Dilute the serum (or plasma) specimen 1000 times with 0.85% NaCl solution.
  2. Open a pouch containing a cassette, remove the test kit from the pouch and place it horizontally on the desk.
  3. Pipette 2 or 3 drops of diluted specimen into the sample well of the cassette.
  4. Read results within 10-15 minutes. Do not read results after 20 minutes.

 

INTERPRETATION OF RESULTS

Negative: Only one pink band appears on test region of the Cassette. This indicates that there is no detectable anti-HAV IgM in the serum.

Positive: Two pink bands appear on test region of the Cassette. This indicates that the specimen contains detectable amount of anti-HAV IgM.

Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.

 

PRECAUTION:

1銆丮ust use fresh specimen and avoid repetitive freezing, the result will be invalid

2銆乁se it before expiry date.

3銆乀he package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator. Use the test kit as soon as possible but within 1 hour after removal from pouch specially if the room temperature is more than 30鈩 and in high humidity environment.

4銆丱ld Serum can not be used. If the serum is thick, it can be used only after being separated.

LIMITATIONS

1銆乀he test is for in-vitro diagnostic use only.

2銆乀he test is qualitative filter detection锛宨t can not be used as the final test for blood donor.

 

STORAGE AND STABILITY

The test kit can be stored at room temperature (2 to 30掳C) in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.

 

REF.DescriptionCBM/ctnKGS/ctn
L113303HAV lgM聽 test cassette 3.0mm for Serum, 4NCU/ml0.0699
L113304HAV lgM聽 test cassette 4.0mm for Serum, 4NCU/ml0.0699
L113307HAV lgM聽 test cassette 3.0mm for Whole Blood, 4NCU/ml0.0699
L113308HAV lgM聽 test cassette 4.0mm for Whole Blood, 4NCU/ml0.0699

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