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Frequently Asked Questions (FAQs) about GE4

updated time:2026-01-08


Q1: What is the purpose of turning on the GE4 Isothermal Amplification Analyzer in advance?


A1: Preheating the instrument in advance is to allow it to warm up, ensuring that the reagents react at a constant temperature. After sample loading is completed, the reagents can be directly placed into the instrument for reaction. Keep the instrument lid closed during the preheating process.


Q2: What will happen if the instrument is not turned on in advance and the samples are directly placed into it after loading?

A2: If the instrument is not preheated in advance and fails to reach a constant temperature before sample loading, placing the reagents into the instrument during the heating process will have no impact on negative and strong positive samples. However, it may lead to false negative results or invalid outcomes for weak positive samples. In such cases, it is recommended to repeat the test in accordance with the standard operating procedures.


Q3: How to determine that the GE4 has finished preheating and entered the standby state for testing?

A3: The GE4 is ready for testing when the word "Ready" appears on the display screen.


Q4: What types of samples is this instrument compatible with?

A4: It is suitable for reagents using samples such as blood, feces, and swabs (nasopharyngeal swabs, urethral swabs, vaginal swabs, etc.). It is not applicable to the company's square-tube format products, chip format products, or any non-company products.


Q5: How can the samples be used after collection?

A5:  ① They can be immediately tightened and connected with the detection reagents for testing;② The sample collection tube cap can be tightened for sample transportation and storage.


Q6: What will happen if the samples are not inverted and mixed well, nor stood vertically for 2-3 minutes during sample processing?

A6: It may result in poor sample purification efficiency, thereby causing false negative results for low-concentration samples.


Q7: How long can the processed samples be allowed to stand?

A7: As long as the samples do not flow into the detection chamber, the test results will not be affected within 30 minutes. Do not squeeze the samples before testing to prevent the sample liquid from flowing into the detection chamber prematurely.


Q8: During sample processing, after inverting and mixing 7-10 times and then standing vertically for 2-3 minutes, do not squeeze the sample processing hose. What will happen if the hose is squeezed by mistake, causing some samples to flow into the detection chamber prematurely and come into contact with the white lyophilized powder?

A8:  ① Premature inflow of incompletely processed samples will lead to poor detection rates or false negative results for medium and low-concentration samples;

② The entry of a small amount of liquid will cause partial dissolution and collapse of the lyophilized detection reagents, resulting in difficulty in dissolving the reagents and increased mixing complexity.


Q9: What are the correct sample loading steps for pen-type microfluidic detection? If liquid flows into the detection chamber with difficulty during sample loading, how to improve the operation to ensure that the samples fully fill the entire detection chamber?

A9: The correct sample loading procedure is to squeeze the tube twice and then flick it twice, repeating the operation until the samples fully fill the entire detection chamber. If liquid inflow is difficult during squeezing:
  1. Squeeze the hose as much as possible to deform it, and maintain the squeezed state without releasing it during liquid inflow to avoid liquid backflow;

  2. Squeeze and hold the hose tightly (without releasing it) while flicking it 2-3 times to facilitate rapid liquid entry and full filling of the detection chamber;

  3. The presence of small air bubbles in the detection chamber is a normal phenomenon. However, if a large portion of the chamber remains unfilled, it may affect the detection rate of low-concentration samples and lead to false negative results.


Q10: How to mix the reagents thoroughly to ensure the optimal detection effect?

A10:  ① After the samples enter and fill the detection chamber, let them stand for 30 seconds to 1 minute (maximum extension to 3 minutes). Standing for more than 3 minutes will affect the detection rate of low-concentration samples;

② Mix gently by flicking 3-5 times / swirling manually 5-8 times / vortex mixing for 1-3 seconds until the detection reagents are completely dissolved;

③ Do not invert the detection chamber to mix after adding the samples, to prevent the reaction reagents in the chamber from flowing back into the sample processing tube, which may cause false negative or invalid results;

④ For the best detection effect, place the mixed reagents into the isothermal nucleic acid amplification analyzer and start the test immediately. Leaving the mixed reagents standing for more than 3 minutes will affect the detection rate of low-concentration samples.


Q11: After mixing, a small amount of white foam may float on the top of the detection chamber. Will this affect the test results?

A11: The white foam floating on the top of the detection chamber is a normal phenomenon and will not affect the test results.


Q12: How to handle sample or reagent leakage during the test process?

A12: In case of leakage:
  1. If leakage occurs from the sample processing tube before testing, or the sample hose becomes skewed after being tightened: Stop the experiment immediately, clean the leaked area on the laboratory bench with 75% alcohol, and perform manual disinfection.

  2. If reagent leakage occurs before placing the detection reagents into the instrument: Stop the experiment immediately, tighten the reaction tube cap, seal the detection reagents in a biosafety bag, clean the laboratory bench with 75% alcohol, and perform manual disinfection.

  3. If leakage occurs after the reaction is completed: Clean the laboratory bench with 75% alcohol and perform manual disinfection. Then, irradiate the contaminated area with an ultraviolet lamp forat least 2 hours (prolonged irradiation time is acceptable), and enhance laboratory ventilation.


Q13: How turino effectively prevent leakage dg the reaction process?

A13:  1. Before testing, inspect the condition of the relevant components of the detection reagents. If any components are found to be damaged, deformed, skewed, loose, or defective, replace them immediately. Do not proceed with the formal test to minimize the risk of leakage.

2. Take the detection reagents out to reach room temperature 10 minutes in advance for equilibration. This is to ensure that the reagent temperature is consistent with the room temperature, preventing leakage caused by excessive temperature differences before and after placing the reagents into the instrument.


Q14: How to interpret the test results displayed on the GE4?

A14: The instrument displays two types of test results: the negative result is shown as "—" in the graphic area and "Negative" in the letter area; the positive result is shown as "+" in the graphic area and "Positive" in the letter area.
When the above quality control criteria are met, the isothermal nucleic acid amplification analyzer will automatically display the interpretation results as follows:
  • Positive: If the graphic area shows "+" and the letter area shows "Positive", the result can be judged as positive.

  • Negative: If the graphic area shows "-" and the letter area shows "Negative", the result can be judged as negative.

A negative result cannot rule out infection and should not be used as the sole basis for treatment or patient management decisions.
When a diagnostic test result is positive, the possibility of a false positive result should be considered in combination with the patient's recent exposure history and clinical symptoms and signs consistent with infection.


Q15: How long does it take for the final test results to be displayed on the GE4?

A15: The results will be available within 10 minutes. Positive results will be displayed in real time once confirmed, while negative results will be displayed at the 10-minute mark.


Q16: What are the possible causes of abnormal test results?

A16: If abnormal results occur, the following aspects should be considered:
  1. The storage condition of the detection reagents is -20±5℃for 12 months. Failure to store the reagents in accordance with the instructions or using expired products may lead to false negative or invalid results.

  2. Improper operations such as opening the reaction tube after the reaction, not replacing pipette tips, or not changing disposable gloves may cause laboratory contamination, resulting in false negative or false positive results. It is necessary to check for potential contamination.

  3. Failure to process samples or load samples in accordance with the instructions may result in excessively high levels of inhibitors in the test system, reducing the functionality of some components in the detection reagents and leading to false negative results.

  4. Failure to perform sample loading operations as instructed, resulting in insufficient filling of the detection chamber with liquid reagents or incomplete dissolution of the lyophilized reagents, may lead to false negative, false positive, or invalid results.

  5. Conducting the test with the instrument exposed to direct sunlight may cause false positive results.

  6. For square-tube format detection, failure to flick the mixed detection reagents to the bottom of the tube; or for pen-type microfluidic detection, insufficient filling of the detection chamber with liquid may both lead to abnormal test results.

  7. Removing the detection reagents from the instrument during the test or reinserting them after removal may cause abnormal results.

  8. The power supply does not meet the requirements of the GE4 instrument.


Q17: What are the power supply requirements for the normal operation of the GE4? Can it be used if the power supply voltage is too high or too low?

A17: The power supply requirements for the normal operation of the GE4 are DC 5V 3A, 15W. The instrument cannotbe used if the power supply voltage is either too high or too low.


Q18: How to dispose of the detection reagent devices after the test is completed?

A18: The used detection reagent devices must be sealed properly to prevent leakage. For frequently used testing locations, regular environmental cleaning and disinfection are required.


Q19: Can the GE4 query historical test results?

A19: Historical result query is not supported at present, but this function is under development. Currently, test data must be recorded manually, and the current version does not support automated data storage.


Q20: What is the shelf life of the GE4 devices?

A20: The GE4 have a shelf life of 3 years (under recommended storage conditions: -20℃~55℃,Relative humidity ≤90%).