IgG IgM Tuberculosis Rapid Test Kit

TB (Tuberculosis) Rapid Test Kit

For the Qualitative Detection of Antibody against Tuberculosis in serum and plasma

Main Features

♦ High Sensitivity

♦ Specificity

♦ Reliable: high accurate, early detection of the presence of TB

♦ Simple: No Instrument Required

♦ Convenient: Room Temperature Storage, Built-In Control line

♦ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

♦ Certified by Authoritative Certification System and Standards

♦ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

Summary

Tuberculosis Rapid Test (Whole Blood/Serum/Plasma) is a membrane-based screening test for the rapid detection of IgM anti-Mycobacterium Tuberculosis and IgG anti-Mycobacterium Tuberculosis in human whole blood, serum or plasma.

This innovative rapid screening test is based on lateral flow immunochromatography and is among the easiest point of care (POC) assay diagnostics.

The Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)is suitable to test for antibodies in whole blood, serum or plasma. It is for professional in vitro diagnostic use only.

Main Specifications

Materials Supplied

1.Test Cassette

2 Pipette Dropper

3.Desiccant

4.Buffer

5.Package Insert

Material Required But Not Provided

1. Clock or Timer
2. Specimen collection containers.
3. Timer
4. Lancets (for fingerstick whole blood only)
5. Centrifuge (for plasma only)

Specimen Collection

1. The TB Tuberculosis Rapid Test (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick) serum, or plasma specimens.

2. To collect Venipuncture Whole Blood Specimens: Collect anti-coagulated blood sample (EDTA, heparin, and sodium citrate) following standard laboratory procedures.

3. To collect Fingerstick Whole Blood Specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.

Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.

Puncture the skin with a sterile lancet. Wipe away the first sign of blood. Add the Fingerstick Whole Blood specimen to the test cassette by using hanging drop:

Position the patient’s finger so that the drop of blood is just above the sample pad(s) of the test cassette.

Allow 2 hanging drops of fingerstick whole blood to fall into the center of sample pad(s) on the test cassette, or move the patient’s finger so that the hanging drop touches the center of the sample pad(s). Avoid touching the finger directly to the sample pad(s).

Gently form a rounded drop of blood over the puncture site and add the fingerstick whole blood specimen to test device using a capillary tube Touch the end of capillary tube to blood until filled to approximately 50 ul .

Place the bulb onto the top end of the capillary tube dispense the whole blood into the specimen well(s) of the test device.

4. Separate Whole Blood,serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear,
non-hemolyzed specimens.

5. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

6. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

7. If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.

Interpretation of Results

Negative: No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no TB antibody has been detected.

Positive: In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains TB.

Invalid: If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

Storage and Stability

All reagents are ready to use as supplied. Store unused test device unopened at 2°C-30°C.
If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test
device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the
kit over 30°C.

Warnings and Precautions

1. For professional In Vitro diagnostic use only.

2. Warning: the reagents in this kit contain sodium azide which may react with lead or copper plumbing to form
potentially explosive metal azides. When disposing of such reagents, always flush with large volumes of water to
prevent azide build-up.

3. Do not use it if the tube pouch is damaged or broken.

4. Test is for single use only. Do not re-use under any circumstances.

5. Handle all specimens as if they contain infectious agents. Observe established standard procedure for proper
disposal of specimens

6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are
assayed.

7. Humidity and temperature can adversely affect results.