INTENDED USE

D-Dimer Qualitative Rapid Test Kit is intended for use in the detection of D-Dimer in human plasma or whole blood, at a cut off concentration of 0.4mg/L. It is for health care professional use only.

PRINCIPLE

The D-Dimer Qualitative Test is a chromatographic immunoassay (CIA) for the detection of antigens to D-Dimer in human plasma or whole blood. D-Dimer specific antibody are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with D-Dimer specific antibodies. Antigen to D-Dimer, if present, a red colored band will develop on the membrane in proportion to the amount of D-Dimer antigens presented in the specimen. Absence of this red colored band in the test region suggests a negative result.To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antigens to D-Dimer.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).

PROCAUTION

1. For in vitro diagnostic use only.

2. All patient samples should be treated as if capable of transmitting diseases.

3. Do not interchange reagents from different lots or use test kit beyond expiration date.

4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

SPECIMEN COLLECTION

Whole Blood

1. Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
2. Carefully withdraw the blood for testing, or label and store it at 2-8°C for up to two weeks.

Plasma

1. Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

2. Separate the plasma by centrifugation.

1. Carefully withdraw the plasma for testing, or label and store it

at 2-8°C for up to 1 weeks. Plasma may be frozen at -20°C for at least 3 months.

Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year

PROCEDURE

Add 1 drop of plasma/ whole blood into the sample well and then add 1 drops of chasing buffer into the sample well. Observe the result in 15 minutes.

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 D-Dimer has been detected.

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

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.

LIMITATION

Measurement range: D-Dimer Qualitative Rapid Test Kit support the use of the rapid immuno assay reader, and the Qualitative range of the sample is 0-10ng/mL.

The result is only for clinical reference and should not be as the only basis for patients with clinical diagnosis and treatment.The clinical management of patients should be combined with its symptoms/signs, history and other laboratory examination, treatment response and epidemiological information such as the comprehensive consideration.

PERFORMANCE CHARACTERISTICS

1. Sensitivity: 0.4mg/L.

2. Specificity:

The specificity of D-Dimer Qualitative Rapid Test Kit was determined from cross-reaction studies with 100mg/ml Alb, 5mg/ml Fibrinogen, and 20mg/ml Immunoglobulin. 100mIU/m Human Chorionic Gonadotropin Hormone (hCG) 200mIU/ml Human Luteinizing Hormone (hLH) 200mIU/ml

3. Total accuracy: Testing by a series of different concentrations of internal control products, the deviation between testing value and standard should be less than±15%.

REPRODUCIBILITY

1) Within run performance test was determined by one analyst with ten devices of one lot for 1 negative and 3 different positive control specimens. There was no variation within the test devices of one lot.

2) Between run performance test was determined by three analyst with 3 different lots for 1 negative and 3 different positive control specimens. There were no variation of results between different analyst.

DISCLAIMER

All instructions given in the package insert must be strictly followed in order to obtain valid results. Any deviation from the given procedure may give erroneous results and therefore, the manufacture, the distributor, or its associates will not be liable for any losses, claims, liability, costs or damages, whether direct or indirect or consequential arising out of or related to an incorrect result, whether a positive or negative by use of this product Once the results indicates positive test, it must be confirmed using a reference test.

INDEX OF SYMBOLS

Do not re-use  manufacture

For In-Vitro Diagnostic use only

Stored at Room Temperature

Attention: See instruction for use

Authorized Representative in the European Company

Use by (Expiration date)  Lot number