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SERATEC® COMBO Pregnancy Test

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SERATEC® COMBO Pregnancy Test SERATEC ® Gesellschaft für Biotechnologie mbH Ernst-Ruhstrat-Str. 5 D -37079 Göttingen, Germany Phone: +49 (0)551/504 800 • Fax: +49 (0)551/504 80 80 • e-mail: [email protected], web: www.seratec.com SERATEC COMBO Pregnancy Test REF HCG-C2 A visual one-step immunoassay for the qualitative detection of human chorionic gonodotropin in serum or urine. For professional In Vitro diagnostic use only. INTENDED USE USER QUALITY CONTROL For the rapid determination of human chorionic gonadotropin (hCG) in The test device is standardized to the recent WHO standard (4 th IRP urine and serum specimens. The test kit is used to obtain a visual, 75/589). The appearance of the control line serves as procedural con- qualitative result and is intended for professional use. trol and indicates proper performance and reactive reagents. However, good laboratory practices recommends the use of external SUMMARY specimens to ensure proper kit performance. Each day of testing, two Human chorionic gonadotropin (hCG) is a glycoprotein hormone se- levels of commercial controls should be tested with the SERATEC ® creted by the developing placenta shortly after fertilization. In normal hCG test devices. The two levels of controls should consist of a nega- pregnancy, hCG can be detected in serum or urine as early as 7 days tive control and a positive control containing low levels of hCG. The use following conception (1-4) using sufficiently sensitive test methods. The of the low level positive control will assure that the test devices have concentration of hCG continues to rise rapidly, frequently exceeding not been adversely affected and are detecting hCG at the stated sensi- 100 mIU/mL by the first missed menstrual period (2-5) and peaking in tivity of the test system. the 30,000 - 100,000 mIU/mL range by 10 - 12 weeks into pregnancy. After this the hCG concentration declines until it reaches values at PRECAUTIONS about one tenth of the maximum for the remainder of the pregnancy. • For single in-vitro diagnostic use. Following delivery, hCG levels rapidly decrease and usually return to • For professional use only. normal within several weeks after parturition. The appearance of hCG • Urine and serum specimens may be potentially infectious. Proper in both, serum and urine, soon after conception and its subsequent rise handling and disposal methods should be established. in concentration during early gestational growth makes it an excellent • Avoid cross-contamination of samples by using new specimen collec- marker for the early detection of pregnancy. tion containers and specimen pipettes for each sample. Healthy men and healthy non-pregnant women do not exhibit detect- • ® Do not use test device if the pouch is damaged able hCG levels with the SERATEC COMBO hCG test. However, • The components of the test that are of animal origin (e.g. antibodies) elevated serum hCG levels comparable to those observed in early do not cause any danger if the test is used according to the instruc- pregnancy may also be associated with trophoblastic or non- tions. trophoblastic neoplasms such as hydatidiform mole, choriocarcinoma. Therefore, the possibility of such diseases should be ruled out before a SPECIMEN COLLECTION positive hCG result is considered diagnostic for pregnancy. Reliable test results can be expected on the first day of the missed ® The SERATEC COMBO hCG device is a rapid lateral flow test for the period. detection of hCG at a level of more than 20 mIU/mL. The test utilizes monoclonal antibodies as active compounds to selectively detect ele- Urine samples vated levels of hCG. The immunological specificity of the test kit virtu- The urine specimen must be collected in a clean, dry container. Speci- ally eliminates cross-reactivity interference from the structurally related mens collected at anytime may be used, however, the first morning glycoprotein hormones hFSH, hLH and hTSH at physiological levels. urine generally contains the highest concentration of hormone. Urine specimens may be refrigerated (2-8°C) and stored up to 72 hours prior PRINCIPLE to assay. If samples are refrigerated, they must be equilibrated to room The SERATEC ® COMBO hCG device is a chromatographic immuno- temperature before testing. Urine samples exhibiting visible precipitates assay (CIA) for the rapid qualitative determination of hCG in serum or should be filtered, centrifuged or allowed to settle and clear aliquots urine. The membrane of the test is precoated with anti-alpha hCG obtained for testing. capture antibody on the test line region and goat anti-rabbit antibodies on the control line region. A glass fibre pad downstream of the mem- Serum samples brane contains dried anti-beta-hCG antibody that has been labelled with No special preparation of the patient specimen is required. Limited gold-conjugate. It can bind to hCG if present in the sample. The pad sample studies indicated that a plasma sample prepared from EDTA also contains gold-conjugated rabbit-antibodies that are a part of the can be used instead of serum. Serum not assayed immediately must control reaction. be stored in the refrigerator (2-8°C, up to 72 hours) or frozen (-20°C, for During testing the dried components are mobilized by the liquid and up to 3 months). Do not freeze and thaw sample repeatedly. Grossly hemolyzed samples should not be used. move upwards by capillary action. In the presence of hCG the colored hCG-antibody-cold-conjugate complex is captured by the immobilized TEST PROCEDURE anti-hCG-antibody on the membrane (sandwich complex) resulting in a 1. Review Specimen Collection instructions. Test device, patient`s red-colored line in the test line region. Independent on the presence of samples, or controls should be brought to room temperature ( 18 - hCG the gold labelled rabbit-antibody will bind in the control line region 30°C) prior to testing. to form the red-colored control line. 2. Remove the test device from its protective pouch (bring the device to This means that hCG positive samples result in the formation of two room temperature before opening the pouch to avoid condensation of colored lines in the test line (T) and control line region (C), whereas moisture on the membrane). Label the device with patient or control hCG negative samples only exhibit one colored line in the control line identifications. region. The appearance of the control line confirms the proper capillary 3. Draw the sample to the line marked on the pipette (approximately 0.1 flow and the correct handling of the test device. mL). Hold the pipette in a straight up and down position - not an an- STORAGE AND STABILITY gle. Dispense 3 drops (approximately 0.1 mL) of the specimen or control into the sample well. For each sample or control, use a sepa- The test kit is to be stored at refrigeration (+2-8°C) or at room tempera- rate pipette and device. ture (up to 30°C) in the sealed pouch for the duration of the shelf life. Do not use beyond expiration date. MATERIALS SUPPLIED • Test devices with disposable pipettes • One instruction leaflet MATERIALS REQUIRED BUT NOT PROVIDED • Timer • Specimen collection containers 4. Wait for the colored lines to appear in the test area. Depending on the concentration of hCG, positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (5 min) is required. Do not interpret results after 5 min- utes. SERATEC ® Combo user instruction page1 SERATEC ® Gesellschaft für Biotechnologie mbH Ernst-Ruhstrat-Str. 5 D -37079 Göttingen, Germany Phone: +49 (0)551/504 800 • Fax: +49 (0)551/504 80 80 • e-mail: [email protected], web: www.seratec.com INTERPRETATION OF RESULTS hCG added 0 10 20 40 100 Negative result: (mIU/mL) Only one colored line appears in the control region (C). No apparent samples 20 20 20 20 20 line in the test line region (T) indicates a negative result. negative 20 10 0 0 0 positive 0 10 20 20 20 Positive result: Two red lines indicate a positive result. In addition to the red colored B. Serum control line (C), a distinct red colored line appears in the test line Pooled serum samples from five known non-pregnant subjects were region (T). The color of the test result line can be less or more intent tested under the same conditions as the urine samples. The results than that of the control line. Even a weak test result line is a positive are summarized in the following table. result and indicates an elevated hCG level. hCG added 0 10 20 40 100 Invalid: (mIU/mL) A total absence of a colored line in the control line region is an indica- samples 20 20 20 20 20 tion of a procedural error and/or a deterioration of test reagents. Add negative 20 16 0 0 0 some additional drops of sample to the sample well. If still no colored positive 0 4 20 20 20 band appears, the test should be voided. Accuracy A. Urine 100 randomly selected urine samples were analyzed by the SERATEC ® hCG device test procedure in parallel with a commer- cially available one step hCG test. The results indicated complete agreement (60 positive samples and 40 negative samples). B. Serum 100 randomly selected serum samples were analyzed by the ® SERATEC COMBO hCG device test procedure in parallel with another commercially available pregnancy test. Here also the results NOTES ON THE INTERPRETATION OF RESULTS indicated complete agreement (66 positive samples and 34 negative • Negative test results for patients strongly suspected to be pregnant samples). should be repeated with a sample obtained 48 to 72 hours later, or by performing a quantitative assay. When testing a urine specimen, Interference testing/Cross reactivity the first morning urine would contain the highest hCG concentra- The following substances were added to hCG free and 20 mIU/mL tion.
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