What Is A Cassette Pregnancy Test?

What Is A Cassette Pregnancy Test
The hCG Pregnancy Rapid Test Cassette is a rapid test that qualitatively detects the presence of hCG in urine or serum or plasma specimen at the sensitivity of 10mIU/mL. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine or serum or plasma.
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How do you use a cassette pregnancy test?

Accu-Tell ® HCG Pregnancy Rapid Test Cassette/Strip (Serum/Plasma/Urine) is a One Step chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum or plasma to aid in the early detection of pregnancy. Product Description CATALOG

Product Name Specimen Catalog No. Quantity per box Certificate
HCG Strip Serum/Plasma/Urine ABT-FT-A2 100T CE
HCG Cassette Serum/Plasma/Urine ABT-FT-B2 25T CE

KEY POINTS Detection for: Human chorionic gonadotropin (HCG) in plasma, Serum, and urine Reading time: at 3 minutes when testing a urine specimen, or at 5 minutes when testing a serum or plasma specimen Sensitivity: 25 mIU/mL Relative Specificity: >99.9% Accuracy: >99.9 % INTRODUCTION Human chorionic gonadotropin(HCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization.

In normal pregnancy, HCG can be detected in both urine and serum or plasma as early as 7 to 10 days after conception. HCG levels continue to rise very rapidly,frequently exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy.

The appearance of HCG in both urine and serum or plasma soon after conception, and its subsequent One Step rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy. INTENDED USE ACCU-TELL ® HCG Pregnancy Rapid Test Cassette/Strip (Serum/Plasma/Urine) is a One Step chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum or plasma to aid in the early detection of pregnancy. For Strip: For Cassette: 1. Bring the pouch to room temperature (15-30℃) before opening it. Remove the cassette from the sealed pouch and use it as soon as possible.2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine or serum or plasma (approximately 120ul) to the specimen well of the cassette, and then start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.3. Wait for the colored line(s) to appear. Read the result at 3 minutes when testing a urine specimen, or at 5 minutes when testing a serum or plasma specimen. NOTE: A low HCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time; therefore, do not interpret the result after 10 minutes. For Strip: 1. Bring the pouch or canister to room temperature before opening it. Remove the test strip from the sealed pouch or closed canister and use it as soon as possible.2. With arrows pointing toward the urine or serum or plasma specimen, immerse the test strip vertically in the urine or serum or plasma specimen for at least 15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip. See illustration below.3. Place the test strip on a non-absorbent flat surface, start the timer and wait for the colored line(s) to appear. Read the result at 3 minutes when testing a urine specimen, or at 5 minutes when testing a serum or plasma specimen. NOTE: A low HCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time. Do not interpret the result after 10 minutes. PERFORMANCE CHARACTERISTICS Accuracy A multi-center clinical evaluation was conducted comparing the results obtained using ACCU-TELL ® HCG Pregnancy Rapid Test Cassette/Strip (Serum/Plasma/Urine) to another commercially available urine and serum or plasma HCG One Step test. The urine study included 413 specimens, and both assays identified 296 negative and 117 positive results. The serum study included 200 specimens, and both assays identified 141 negative and 59 positive results. The plasma study included 200 specimens, and both assays identified 141 negative and 59 positive results. The results demonstrated a >99% overall accuracy of ACCU-TELL® HCG Pregnancy Rapid Test Cassette/Strip (Serum/Plasma/Urine) when compared to the other urine and serum or plasma HCG One Step test. Sensitivity and Cross-Reactivity ACCU-TELL ® HCG Pregnancy Rapid Test Cassette/Strip (Serum/Plasma/Urine) detects HCG at a concentration of 25 mIU/ml or greater. The test has been standardized to the W.H.O. International Standard. The addition of LH (300mIU/mL), FSH (1,000 mIU/ml), and TSH (1,000μIU/ml) to negative (0 mIU/ml HCG) and positive (25 mIU/ml HCG) specimens showed no cross-reactivity. Precision Intra-Assay Within-run precision has been determined by using 10 replicates of three specimens containing 25 mIU/ml, 100 mIU/ml, 250 mIU/ml and 0 mIU/ml of HCG. The negative and positive values were correctly identified 100% of the time. Inter-Assay Between-run precision has been determined by using the same three specimens of 25 mIU/ml, 100 mIU/ml, 250 mIU/ml and 0 mIU/ml of HCG in 10 independent assays. Three different lots of ACCU-TELL ® HCG Pregnancy Rapid Test Cassette/Strip (Serum/Plasma/Urine) have been tested. The specimens were correctly identified 100% of the time. Interfering Substance The following potentially interfering substances were added to HCG negative and positive specimens.

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Acetaminophen 20 mg/dL Caffeine 20 mg/dL
Acetylsalicylic Acid 20 mg/dL Gentisic Acid 20 mg/dL
Ascorbic Acid 20 mg/dL Glucose 2 g/dL
Atropine 20 mg/dL Hemoglobin 1 mg/dL
Bilirubin 2 mg/dL Bilirubin (serum or plasma ) 40 mg/dL
Triglycerides(serum or plasma ) 1,200 mg/dL

None of the substances at the concentration tested interfered in the assay. LIMITATIONS 1. ACCU-TELL ® HCG Pregnancy Rapid Test Cassette/Strip (Serum/Plasma/Urine) is a preliminary qualitative test, herefore, neither the quantitative value nor the rate of increase in HCG can be determined by this test.2.

Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of HCG. If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.3. Very low levels of HCG (less than 50mIU/mL) are present in urine specimens shortly after implantation.

However, because a significant number of first trimester pregnancies terminate for natural reasons,5 a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.4. This test may produce false positive results.

  • A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of HCG.
  • Therefore, the presence of HCG in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.5.

This test may produce false negative results. False negative results may occur when the levels of HCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.

  • In case pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.6.
  • As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen.
  • Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA.

Such specimens may cause false positive or false negative results.7. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
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Is pregnancy test cassette accurate?

How accurate is the test? This test is over 99% accurate if used 7 days after your next period is due. Hormone levels in women do vary and some women may not have detectable levels of the hormone on the first day they test for it.
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When can I use pregnancy test cassette?

EXTRA INFORMATIONS – 1, How does the test cassette work? HCG Pregnancy Rapid Test Cassette detects a hormone in your urine that your body produces during pregnancy (hCG-human chorionic gonadotropin). The amount of pregnancy hormone increases as pregnancy progresses.2. How soon after I suspect that I am pregnant can I take the test? You can test your urine as early as the first day you miss your period. You can perform the test anytime of the day; however, if you are pregnant, first morning urine contains the most pregnancy hormone.3. Do I have to test with first morning urine? Although you can test at any time of the day, your first morning urine is usually the most concentrated of the day and would have the most hCG in it.4. How accurate is the test? A clinical evaluation was conducted comparing the results obtained using the HCG Pregnancy Rapid Test Cassette to another commercially available urine hCG test. The consumer clinical trial included 608 urine specimens: both assays identified 231 positive and 377 negative results. The results demonstrated >99% overall accuracy of the HCG Pregnancy Rapid Test Cassette when compared to the other urine hCG test.5. How sensitive is the test? HCG Pregnancy Rapid Test Cassette detects hCG in urine at a concentration of 25 mIU/mL or greater. The test has been standardized to the W.H.O. International Standard. The addition of LH (300 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 μIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/mL hCG) specimens showed no cross-reactivity.6. What should I do if the result shows that I am pregnant? It means that your urine contains hCG and you are probably pregnant. See your doctor to confirm that you are pregnant and to discuss the steps you should take.7. How do I know that the test was run properly? The appearance of a colored line in the control line region (C) tells you that you followed the test procedure properly and the proper amount of urine was absorbed.8. What should I do if the result shows that I am not pregnant? It means that no hCG has been detected in your urine and probably you are not pregnant. If you do not start your period within a week of its due date, repeat the test with a new test device. If you receive the same result after repeating the test and you still do not get your period, you should see your doctor.
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How sensitive are cassette pregnancy tests?

Product Description – The hCG series professional pregnancy cassette with pipettes tests are the preferred clinical brand for early detection of hCG (Human Chorionic Gonadotropin) in serum or urine specimens. This test kit is used to obtain a visual, qualitative result for early detection of pregnancy. The pregnancy test cassette kit is for use in the monitoring of early pregnancy (6-15 days after egg fertilization) with the test line accurate sensitivity of 20 mIU/mL and specificity >99%. Early pregnancy tests work by detecting the increase in human Chorionic Gonadotropin (hCG) hormone in urine that starts to develop after the fertilization of the egg (ovum). HCG rapidly starts to increase at exponential levels (see Pregnancy hCG development table). Each home pregnancy test kit has both U.S. FDA 510k Cleared and Health Canada Medical Device Licensed and are sold internationally at manufacturer direct wholesale prices, providing a inexpensive pregnancy test alternative. Whether it is clinical or home application, these pregnancy tests are useful tools for pre-screening purposes that show easy to read and accurate results within just minutes.
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How accurate is hCG combo cassette test?

This test reliably detects intact hCG up to 500,000 mIU/mL. It does not reliably detect hCG degradation products, including free-beta hCG and beta core fragments. Quantitative assays used to detect hCG may detect hCG degradation products and therefore may disagree with the results of this rapid test.
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Can peeing on the window of a pregnancy test give false-positive?

I peed on the test result window; does it affect the result? – It happens! As we stated above, the test window isn’t waterproof, so it’s possible you could get an inaccurate result. Try taking another test (use a cup and dip the test if that’s easier!) to ensure you’re getting accurate results.
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Which pregnancy test shows the earliest?

The best pregnancy test strips (with cups) – As accurate and nearly as sensitive as First Response Early Result at the time of a missed period, these inexpensive strips (currently about 30¢ per test) are useful for anyone who anticipates testing often.
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What pregnancy test is too early?

When should I take a home pregnancy test? Many home pregnancy tests claim to be accurate as early as the first day of a missed period — or even before. You’re likely to get more accurate results, however, if you wait until after the first day of your missed period.
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Why do you have to wait 2 weeks to take a pregnancy test?

– You should wait to take a pregnancy test until the week after your missed period for the most accurate result. If you don’t want to wait until you’ve missed your period, you should wait at least one to two weeks after you had sex. If you are pregnant, your body needs time to develop detectable levels of HCG.
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What do invalid pregnancy tests look like?

H ow do I read the test results? – Pregnancy hormone levels present – 2 red lines in both the test window (T) and control window (C) means you may have retained products of conception. One line may be lighter than the other; they do not have to match. No pregnancy hormone level present 1 red line in the control window (C) means that your pregnancy hormone levels are falling and the products of conception has been passed. Invalid Result The result is invalid (the test has not worked) if no red line appears in the control window (C), even if a line appears in the test window (T). You should repeat the test with a new midstream urine test using a new device. What will happen next?

  1. If you are well and your test is negative you will be discharged.
  2. If the test remains weakly positive (faint line) we will book you in for an assessment.
  3. If you have not had any change in symptoms and the test remains strongly positive you will be asked to return to the hospital for assessment and an ultrasound scan.
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When will my periods return to normal? If your periods were regular before you got pregnant, then your periods should return to normal within 4-6 weeks. This will also depend on what type of contraception you are taking.
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Can I do pregnancy test at night?

If you wonder whether to take a pregnancy test at night or morning, you have come to the right place. Most couples trying to conceive a baby are often concerned about doing everything right to make sure that they are not missing out on anything. Home pregnancy tests are designed to rely on the level of human chorionic gonadotropin in your urine to detect a pregnancy.

There is a rise in the production of this hormone in the placenta during the first eight to twelve weeks of pregnancy. Although you may take a pregnancy test at night, the test may be a false negative since urine tends to be more diluted at night. This is why doctors recommend taking a pregnancy test in the morning, especially in the first couple of weeks of pregnancy.

‍ Book an Appointment with Dr. Manjula Raghuveer for all your concerns related to Gynecology ‍ What Is A Cassette Pregnancy Test
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What does the C and T mean on a pregnancy test?

Pregnancy Test Instructions Instructions for using your pregnancy tests If you miss a period, please take a pregnancy test. We have given you two pregnancy tests for this purpose. If you need additional pregnancy tests, please contact us by phone or email. When you have a POSITIVE PREGNANCY TEST, please CONTACT US TO SCHEDULE YOUR ULTRASOUND. You can call us at 919-843-8246, or email us at, What Is A Cassette Pregnancy Test Instructions:

Remove the plastic cap to expose the absorbent window. Point the absorbent tip (with 5 small openings) directly into the urine stream. Take the sample for at least 7-10 seconds, to ensure that an adequate sample is collected by the testing device. (Another technique is to collect the urine into a clean container and dip half of the absorbent pad for at least 10 seconds.) Re-cap the device and place it horizontally on a clean, flat surface. Wait 5 minutes for the test to finish processing.

RESULT INTERPRETATION Negative Result: NOT PREGNANT Only one color band appears on the top Control (C) region. There should be no apparent band on the Test (T) region. The control line is designed to validate the test and should be crisp and clear in intensity against the white background. Positive Result: POSSIBLE PREGNANCY Distinct and consistent color bands appear on the Control (C) and Test (T) regions. Color intensity of the bands may vary according to concentration and level of hCG development. The test line is usually slightly weaker in intensity in comparison to the control line.

  • The pattern of increasing intensity of the test line is a much better predictor of pregnancy rather than any individual reading.
  • Invalid Results If there is no visible control line, discard the test.
  • Repeat test with a new device.
  • STORAGE Store pregnancy tests at normal room temperature, between 36°F and 86°F.

Discard unused pregnancy tests after the expiration date, which is stamped on each sealed pregnancy test. Avoid prolonged exposure to direct sunlight, moisture, heat, and other related conditions. DISPOSAL Urine samples and used test devices are potentially infectious, so please keep them away from direct contact with objects.
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When taking a pregnancy test do you pee on the stick?

Should I dip my home pregnancy test in urine, or pee on it? Most tests allow you to either place the absorbent tip in your urine stream for (usually) five seconds or dip the tip in a collected urine sample for five to 20 seconds. Accuracy is not dependent on the method as long as you follow the instructions.
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