Click the right arrow to advance the Proper Testing Technique slide show.
![Recommended Quality Control Materials](https://marketing.webassets.siemens-healthineers.com/85f9ec0317f32251/654aab0ed3d4/v/a81ca9911808/17-clinitest_v2.jpg)
Recommended Quality Control Materials
To view a full chart of quality control materials, click on the button below.
![CLINITEST® hCG](https://marketing.webassets.siemens-healthineers.com/cd2de421d4d6ffce/31449d27d8bb/v/8f89c322e548/00-clinitest_v3.jpg)
CLINITEST® hCG test on the CLINITEK Status® Family of Analyzers
![Recommended Quality Control Materials](https://marketing.webassets.siemens-healthineers.com/1f660a0714595e00/66ac7a6f35da/v/6901cd7b38b1/01-clinitest_v2.jpg)
CLINITEST hCG Test
The CLINITEST hCG test is a qualitative, instrument-read test for early detection of pregnancy.
- For use on the CLINITEK Status® family of analyzers
- Uses urine sample only
- Results reported in as little as 2 minutes if positive and up to 5 minutes to confirm negative results
- CLIA-waived when used on the CLINITEK Status family of analyzers
![CLINITEST hCG Test Kit Contents](https://marketing.webassets.siemens-healthineers.com/76a11bea7fe3a13d/58762a24e6f8/v/4f9c5dd10e07/02-clinitest_v2.jpg)
CLINITEST hCG Test Kit Contents
The CLINITEST hCG test kit contains 25 individually wrapped test cassettes. Each foil pack contains:
- 1 single-use pipette
- 1 hCG test cassette
- desiccant to prevent moisture
The test kit can be refrigerated or stored at room temperature (2°-30°C / 36°-86°F). Do not use the test cassettes beyond the expiration date.
![Preparing to run an hCG test](https://marketing.webassets.siemens-healthineers.com/9ce783978ffb7277/44a0ebd66496/v/2e2864c40140/03-clinitest_v2.jpg)
Preparing to run an hCG test
Before performing a CLINITEST hCG test on the CLINITEK Status analyzer, be sure to:
- Collect urine specimen in a clean, dry container
- Make sure you have the CLINITEST hCG cassette, the pipette, and the urine specimen
- Turn the analyzer ON
Helpful Hints to Avoid Errors
Test fresh urine sample within 2 hours of collection. Refrigerate specimen at 2°-8°C for up to 72 hours if the testing is not done immediately.
Refrigerated urine samples should be brought to room temperature (20°-30°C) before testing.
DO NOT test urine samples that look bloody or if they are not a normal color.
![Step 1 – Select Test Option](https://marketing.webassets.siemens-healthineers.com/f4986a438717a254/5c2bcd501acf/v/8a788b759eb6/04-clinitest_v2.jpg)
Step 1 – Select Test Option
To perform the test:
- Select "Cassette Test" from the Select Ready screen on the analyzer
![Step 2 – Enter Operator Information](https://marketing.webassets.siemens-healthineers.com/801a4ec7a516fe83/dc788ff6da42/v/7b3cb9ec89cf/05-clinitest_v2.jpg)
Step 2 – Enter Operator Information
To perform the test:
- Enter your assigned operator ID, if prompted
Note: Operator ID can be entered using the onscreen keyboard or via the bar code scanner*
* bar code scanner is available on the CLINITEK Status® Connect System only
![Step 3 – Enter Patient Information](https://marketing.webassets.siemens-healthineers.com/84f2109f1a4b4de1/33fa1632fe82/v/df24e309d65a/06-clinitest_v2.jpg)
Step 3 – Enter Patient Information
To perform the test:
- Enter the patient demographics (ID and/or Name), if prompted
Note: Patient demographics can be entered using the onscreen keyboard or via the bar code scanner*
* bar code scanner is available on the CLINITEK Status® Connect System only
![Step 4 – Select CLINITEST hCG Cassette](https://marketing.webassets.siemens-healthineers.com/dafbeba685ff9a99/6358c9284bec/v/5995ab845236/07-clinitest_v2.jpg)
Step 4 – Select CLINITEST hCG Cassette
To perform the test:
- Select "CLINITEST hCG Cassette"
![Step 5 – Turn Test Table](https://marketing.webassets.siemens-healthineers.com/d73471c80d462ad9/013f54829c64/v/19718512bb13/08-clinitest_v2.jpg)
Step 5 – Turn Test Table
To perform the test:
- Turn test table insert so cassette holder is facing upward
Note: The test table, the table insert, and the calibration bar need to be clean. Be sure to follow the recommended maintenance procedure.
![Step 6 – Place Cassette](https://marketing.webassets.siemens-healthineers.com/17777903df5122a7/38d0a83af41f/v/ba7316f9a503/09-clinitest_v2.jpg)
Step 6 – Place Cassette
To perform the test:
- Remove a cassette from the foil package
- Place the hCG cassette onto the test table
Helpful Hints to Avoid Errors
Do not add sample to the cassette until prompted by the analyzer.
![Step 7 – Select Start](https://marketing.webassets.siemens-healthineers.com/806a6d866f6704e6/d1a645f03997/v/b9feea44c390/10-clinitest_v2.jpg)
Step 7 – Select Start
To perform the test:
- Select "Start" to begin the sampling procedure
Note: You will have 8 seconds to draw and add sample.
Helpful Hints to Avoid Errors
Do not add sample to sample well until after pressing the "Start" button.
![Step 8 – Draw Sample](https://marketing.webassets.siemens-healthineers.com/bb4edba45fdb9c21/ff3e8cf78aae/v/0f75f5c884b3/11-clinitest_v2.jpg)
Step 8 – Draw Sample
To perform the test:
- Draw the sample and completely fill the pipette stem
Note: Any excess sample will go into the overflow reservoir.
Helpful Hints to Avoid Errors
Use only the pipette provided with each cassette.
Ensure the pipette stem is completely full.
![Step 9 – Add Sample](https://marketing.webassets.siemens-healthineers.com/708fb238582151d9/22e8c139383d/v/2b694e12735b/12-clinitest_v2.jpg)
Step 9 – Add Sample
To perform the test:
- Empty only 1 pipette stem into the cassette sample well
Note: The pipette is specially designed to deliver the required 200 µL sample volume.
- The CLINITEK Status analyzer will automatically draw the test table into the analyzer for processing.
Helpful Hints to Avoid Errors
Do not overfill the sample, only 1 pipette stem is required.
Ensure the entire pipette stem is dispensed.
Do not attempt to dispense any sample that is in the overflow reservoir.
It is recommended to use the pipette provided with the cassette to
dispense the quality control materials. Counting drops may lead to
erroneous results.
If you are using dropper bottles for quality control materials, ensure
that only 200 µL of control material is added for testing.
![Step 10 – Get Result](https://marketing.webassets.siemens-healthineers.com/19aa61ca47e51bf5/21ff1e641792/v/42efc83b9343/13-clinitest_v2.jpg)
Step 10 – Get Result
To perform the test:
- The analyzer will automatically time and record the result.
- Results can be automatically printed and/or sent to the electronic medial record, data management system or LIS, if connected.
Note: CLINITEST hCG can take up to 5 minutes to perform the test (strongly positive samples may be detected more quickly).
- Once the test is completed, remove the cassette.
![Results Interpretation](https://marketing.webassets.siemens-healthineers.com/ecada72d33b92fc5/22518f49d416/v/c8dc4c41e7a9/14-clinitest_v2.jpg)
Results Interpretation
- If a positive result is obtained on an individual where pregnancy is not suspected, repeat the test with another urine sample 24 hours later or confirm with an alternative method.
- If a borderline result is obtained repeat test in 48–72 hours.
- In acute situations, have a blood sample drawn from the patient and confirm result by a quantitative lab test.
![Avoid Common Errors](https://marketing.webassets.siemens-healthineers.com/e90246b46416261b/c294c4cb8d61/v/258565d359fe/15-clinitest_v2.jpg)
Avoid Common Errors
Tips to avoid common errors:
- Use only pipette provided with test kit to ensure proper volume of 200 µL is delivered.
- Do not overfill sample well on hCG cassette, only 1 pipette stem is required. Overfilling leads to erroneous results.
- Only empty sample in pipette stem, do not attempt to empty sample from overflow reservoir. It is normal for excess sample to remain in overflow reservoir.
- Add sample to sample well only after pressing the START button.
- Use recommended quality control solutions. If using dropper bottles for QC materials, ensure only 200 µL of material is added for testing.
- Properly store cassettes.
- Use CLINITEK Status Family of analyzers to interpret results.
- Avoid using visibly bloody sample, severely turbid, viscous, or highly colored samples.
- Use samples and cassettes at room temperature.
- Follow proper cleaning and maintenance procedures.
![Quality Control](https://marketing.webassets.siemens-healthineers.com/a6f009eb3eb6b55e/a150e9be47f7/v/64288e59bca8/16-clinitest_v2.jpg)
Quality Control
- Use recommended quality control solutions.
- It is recommended to use only the pipette provided with the hCG cassette to ensure only 200 µL of QC material is dispensed.
- If using dropper bottles for QC materials, ensure only 200 µL of material is added for testing.
- Counting the number of drops of QC materials may lead to incorrect sample volume and erroneous QC test results.
- Using more or less than the required 200 µL may cause an error.
![Recommended Quality Control Materials](https://marketing.webassets.siemens-healthineers.com/85f9ec0317f32251/654aab0ed3d4/v/a81ca9911808/17-clinitest_v2.jpg)
Recommended Quality Control Materials
To view a full chart of quality control materials, click on the button below.
![CLINITEST® hCG](https://marketing.webassets.siemens-healthineers.com/cd2de421d4d6ffce/31449d27d8bb/v/8f89c322e548/00-clinitest_v3.jpg)
CLINITEST® hCG test on the CLINITEK Status® Family of Analyzers
![Recommended Quality Control Materials](https://marketing.webassets.siemens-healthineers.com/1f660a0714595e00/66ac7a6f35da/v/6901cd7b38b1/01-clinitest_v2.jpg)
CLINITEST hCG Test
The CLINITEST hCG test is a qualitative, instrument-read test for early detection of pregnancy.
- For use on the CLINITEK Status® family of analyzers
- Uses urine sample only
- Results reported in as little as 2 minutes if positive and up to 5 minutes to confirm negative results
- CLIA-waived when used on the CLINITEK Status family of analyzers
![CLINITEST hCG Test Kit Contents](https://marketing.webassets.siemens-healthineers.com/76a11bea7fe3a13d/58762a24e6f8/v/4f9c5dd10e07/02-clinitest_v2.jpg)
CLINITEST hCG Test Kit Contents
The CLINITEST hCG test kit contains 25 individually wrapped test cassettes. Each foil pack contains:
- 1 single-use pipette
- 1 hCG test cassette
- desiccant to prevent moisture
The test kit can be refrigerated or stored at room temperature (2°-30°C / 36°-86°F). Do not use the test cassettes beyond the expiration date.
![Preparing to run an hCG test](https://marketing.webassets.siemens-healthineers.com/9ce783978ffb7277/44a0ebd66496/v/2e2864c40140/03-clinitest_v2.jpg)
Preparing to run an hCG test
Before performing a CLINITEST hCG test on the CLINITEK Status analyzer, be sure to:
- Collect urine specimen in a clean, dry container
- Make sure you have the CLINITEST hCG cassette, the pipette, and the urine specimen
- Turn the analyzer ON
Helpful Hints to Avoid Errors
Test fresh urine sample within 2 hours of collection. Refrigerate specimen at 2°-8°C for up to 72 hours if the testing is not done immediately.
Refrigerated urine samples should be brought to room temperature (20°-30°C) before testing.
DO NOT test urine samples that look bloody or if they are not a normal color.
![Step 1 – Select Test Option](https://marketing.webassets.siemens-healthineers.com/f4986a438717a254/5c2bcd501acf/v/8a788b759eb6/04-clinitest_v2.jpg)
Step 1 – Select Test Option
To perform the test:
- Select "Cassette Test" from the Select Ready screen on the analyzer
![Step 2 – Enter Operator Information](https://marketing.webassets.siemens-healthineers.com/801a4ec7a516fe83/dc788ff6da42/v/7b3cb9ec89cf/05-clinitest_v2.jpg)
Step 2 – Enter Operator Information
To perform the test:
- Enter your assigned operator ID, if prompted
Note: Operator ID can be entered using the onscreen keyboard or via the bar code scanner*
* bar code scanner is available on the CLINITEK Status® Connect System only
![Step 3 – Enter Patient Information](https://marketing.webassets.siemens-healthineers.com/84f2109f1a4b4de1/33fa1632fe82/v/df24e309d65a/06-clinitest_v2.jpg)
Step 3 – Enter Patient Information
To perform the test:
- Enter the patient demographics (ID and/or Name), if prompted
Note: Patient demographics can be entered using the onscreen keyboard or via the bar code scanner*
* bar code scanner is available on the CLINITEK Status® Connect System only
![Step 4 – Select CLINITEST hCG Cassette](https://marketing.webassets.siemens-healthineers.com/dafbeba685ff9a99/6358c9284bec/v/5995ab845236/07-clinitest_v2.jpg)
Step 4 – Select CLINITEST hCG Cassette
To perform the test:
- Select "CLINITEST hCG Cassette"
![Step 5 – Turn Test Table](https://marketing.webassets.siemens-healthineers.com/d73471c80d462ad9/013f54829c64/v/19718512bb13/08-clinitest_v2.jpg)
Step 5 – Turn Test Table
To perform the test:
- Turn test table insert so cassette holder is facing upward
Note: The test table, the table insert, and the calibration bar need to be clean. Be sure to follow the recommended maintenance procedure.
![Step 6 – Place Cassette](https://marketing.webassets.siemens-healthineers.com/17777903df5122a7/38d0a83af41f/v/ba7316f9a503/09-clinitest_v2.jpg)
Step 6 – Place Cassette
To perform the test:
- Remove a cassette from the foil package
- Place the hCG cassette onto the test table
Helpful Hints to Avoid Errors
Do not add sample to the cassette until prompted by the analyzer.
![Step 7 – Select Start](https://marketing.webassets.siemens-healthineers.com/806a6d866f6704e6/d1a645f03997/v/b9feea44c390/10-clinitest_v2.jpg)
Step 7 – Select Start
To perform the test:
- Select "Start" to begin the sampling procedure
Note: You will have 8 seconds to draw and add sample.
Helpful Hints to Avoid Errors
Do not add sample to sample well until after pressing the "Start" button.
![Step 8 – Draw Sample](https://marketing.webassets.siemens-healthineers.com/bb4edba45fdb9c21/ff3e8cf78aae/v/0f75f5c884b3/11-clinitest_v2.jpg)
Step 8 – Draw Sample
To perform the test:
- Draw the sample and completely fill the pipette stem
Note: Any excess sample will go into the overflow reservoir.
Helpful Hints to Avoid Errors
Use only the pipette provided with each cassette.
Ensure the pipette stem is completely full.
![Step 9 – Add Sample](https://marketing.webassets.siemens-healthineers.com/708fb238582151d9/22e8c139383d/v/2b694e12735b/12-clinitest_v2.jpg)
Step 9 – Add Sample
To perform the test:
- Empty only 1 pipette stem into the cassette sample well
Note: The pipette is specially designed to deliver the required 200 µL sample volume.
- The CLINITEK Status analyzer will automatically draw the test table into the analyzer for processing.
Helpful Hints to Avoid Errors
Do not overfill the sample, only 1 pipette stem is required.
Ensure the entire pipette stem is dispensed.
Do not attempt to dispense any sample that is in the overflow reservoir.
It is recommended to use the pipette provided with the cassette to
dispense the quality control materials. Counting drops may lead to
erroneous results.
If you are using dropper bottles for quality control materials, ensure
that only 200 µL of control material is added for testing.
![Step 10 – Get Result](https://marketing.webassets.siemens-healthineers.com/19aa61ca47e51bf5/21ff1e641792/v/42efc83b9343/13-clinitest_v2.jpg)
Step 10 – Get Result
To perform the test:
- The analyzer will automatically time and record the result.
- Results can be automatically printed and/or sent to the electronic medial record, data management system or LIS, if connected.
Note: CLINITEST hCG can take up to 5 minutes to perform the test (strongly positive samples may be detected more quickly).
- Once the test is completed, remove the cassette.
![Results Interpretation](https://marketing.webassets.siemens-healthineers.com/ecada72d33b92fc5/22518f49d416/v/c8dc4c41e7a9/14-clinitest_v2.jpg)
Results Interpretation
- If a positive result is obtained on an individual where pregnancy is not suspected, repeat the test with another urine sample 24 hours later or confirm with an alternative method.
- If a borderline result is obtained repeat test in 48–72 hours.
- In acute situations, have a blood sample drawn from the patient and confirm result by a quantitative lab test.
![Avoid Common Errors](https://marketing.webassets.siemens-healthineers.com/e90246b46416261b/c294c4cb8d61/v/258565d359fe/15-clinitest_v2.jpg)
Avoid Common Errors
Tips to avoid common errors:
- Use only pipette provided with test kit to ensure proper volume of 200 µL is delivered.
- Do not overfill sample well on hCG cassette, only 1 pipette stem is required. Overfilling leads to erroneous results.
- Only empty sample in pipette stem, do not attempt to empty sample from overflow reservoir. It is normal for excess sample to remain in overflow reservoir.
- Add sample to sample well only after pressing the START button.
- Use recommended quality control solutions. If using dropper bottles for QC materials, ensure only 200 µL of material is added for testing.
- Properly store cassettes.
- Use CLINITEK Status Family of analyzers to interpret results.
- Avoid using visibly bloody sample, severely turbid, viscous, or highly colored samples.
- Use samples and cassettes at room temperature.
- Follow proper cleaning and maintenance procedures.
![Quality Control](https://marketing.webassets.siemens-healthineers.com/a6f009eb3eb6b55e/a150e9be47f7/v/64288e59bca8/16-clinitest_v2.jpg)
Quality Control
- Use recommended quality control solutions.
- It is recommended to use only the pipette provided with the hCG cassette to ensure only 200 µL of QC material is dispensed.
- If using dropper bottles for QC materials, ensure only 200 µL of material is added for testing.
- Counting the number of drops of QC materials may lead to incorrect sample volume and erroneous QC test results.
- Using more or less than the required 200 µL may cause an error.
![Recommended Quality Control Materials](https://marketing.webassets.siemens-healthineers.com/85f9ec0317f32251/654aab0ed3d4/v/a81ca9911808/17-clinitest_v2.jpg)
Recommended Quality Control Materials
To view a full chart of quality control materials, click on the button below.
Testing Tips
Sample Handling
- Collect specimen in a clean, dry container – specimens collected at any time of the day may be used.
- Test fresh sample within 2 hours of collection. Refrigerate specimen at 2°C to 8°C for up to 72 hours if the testing is not done immediately.
- Refrigerated samples should be brought to room temperature prior to testing.
Hints to Avoid Errors
- Use only pipette provided with each cassette pack to ensure proper volume of 200 µL is dispensed.
- Do not overfill sample well with more than one pipette stem of sample.
- Do not empty overflow reservoir. It is normal for excess sample to remain in overflow reservoir. Do not try to dispel it.
- Do not add sample to the sample well until after you press the START button.
- Visibly bloody or highly colored samples should not be tested
Results Interpretation
- If a positive result is obtained on an individual where pregnancy is not suspected, confirm with an alternative urine or blood method or repeat the test with another urine sample 24 hours later.
- If a borderline result is obtained and pregnancy is suspected, rerun with an alternative urine or blood method or repeat the CLINITEST hCG test in 48-72 hours.
- In acute situations where the test result does not correlate with the observed clinical condition of the patient, have a blood sample drawn from the patient and confirm the CLINITEST hCG result by a quantitative blood test.